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Oleogel-S10 in Wound Healing of Split-Thickness Skin Graft Donor Sites (BSG-12) (BSG-12)

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ClinicalTrials.gov Identifier: NCT01807650
Recruitment Status : Completed
First Posted : March 8, 2013
Results First Posted : July 19, 2018
Last Update Posted : July 19, 2018
Sponsor:
Information provided by (Responsible Party):
Amryt Pharma ( Birken AG )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Wounds
Interventions Drug: Oleogel-S10, non-adhesive wound dressing
Device: Non-adhesive wound dressing only
Enrollment 112
Recruitment Details Participants were enrolled from 04 Apr 2013 to 04 Sep 2013 in 14 clinical centers in 4 countries: Spain (6 centers), Greece (3 centers), Latvia (2 centers), and France (3 centers).
Pre-assignment Details 113 participants were screened and wound halves of 112 participants were randomized and treated. For one participant, wound halves were neither randomized nor treated because the split-thickness skin graft surgery was cancelled. Overall, 112 wounds in 112 participants were treated.
Arm/Group Title Entire Study Population
Hide Arm/Group Description A split-thickness skin graft (STSG) donor site wound >15cm2 in size was divided in 2 halves. One half of the STSG wound was randomized to Oleogel-S10 treatment plus non-adhesive wound dressing. The other wound half was covered with a non-adhesive wound dressing only as control (intra-individual comparison)
Period Title: Overall Study
Number of participants Number of units (STSG donor site wounds)
Started 112 112
Completed 92 92
Not Completed 20 20
Reason Not Completed
Lack of Full Wound Closure at Day 28             13            
Adverse Event             5            
Other             2            
Arm/Group Title Entire Study Population
Hide Arm/Group Description Intra-individual comparison: A split-thickness skin graft (STSG) donor site wound ≥15 cm² in size was divided in 2 halves. One half was randomized to Oleogel-S10 treatment and non-adhesive wound dressing, the other half to non-adhesive wound dressing only. Non-adhesive wound dressings, specifically soft silicone faced polyurethane foam dressings (e.g., Mepilex®), represent standard of care (SOC) in the treatment of STSG donor site wounds. Oleogel-S10 was administered at a thickness of 1 mm (0.04 inches) and wound dressings were changed at least every 3 to 4 days. Study treatment continued until both wound halves were closed (at least 95% epithelialised) or ended at Day 28.
Overall Number of Baseline Participants 112
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants
<=18 years
0
   0.0%
Between 18 and 65 years
89
  79.5%
>=65 years
23
  20.5%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 112 participants
49
(19 to 90)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants
Female
39
  34.8%
Male
73
  65.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 112 participants
Greece 14
Latvia 31
France 11
Spain 56
1.Primary Outcome
Title Intra-individual Difference in Time to Wound Closure
Hide Description Intra-individual difference in time to wound closure between wound halves, either treated with Oleogel-S10 and non-adhesive wound dressing or treated with non-adhesive wound dressing only. Independent experts were blind to treatment and assessed efficacy based on chronological series of cropped and coded photographs by wound half that were taken before start of treatment, during wound dressing changes and at the end of treatment. Difference in time to wound closure was calculated for every individual participant as [time taken for wound half treated with Oleogel-S10 to close] - [time taken for wound half treated with non-adhesive wound dressing to close], i.e., results below 0 indicate earlier wound closure of Oleogel-S10 treatment. The overall mean difference in time to wound closure was calculated based on all mean differences in time to wound closure of individual participants. Hence, primary outcome data derived from mean difference in time to wound closure by participant.
Time Frame 2 to 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) analysis population included all participants who were treated at least once with study medication, i.e. who received any dose of Oleogel-S10 and who had signed an informed consent form.
Arm/Group Title Entire Study Population
Hide Arm/Group Description:
All participants treated with Oleogel-S10 plus non-adhesive wound dressing and with non-adhesive wound dressing only
Overall Number of Participants Analyzed 110
Mean (95% Confidence Interval)
Unit of Measure: days
-0.8
(-1.5 to -0.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Entire Study Population
Comments

All participants received both treatments and treatments were intra-individually compared.

Hypotheses tested: H0: δ = 0 and H1: δ ≠ 0 with δ being the difference in time to wound closure between treatments.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.0232
Comments 2-sided, significance level = 0.05
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Time From Surgery Until Wound Closure is Achieved
Hide Description Time from surgery until wound closure is achieved, separately for wound halves treated with Oleogel-S10 and non-adhesive wound dressing vs. non-adhesive wound dressing only. While outcome measure 1 (intra-individual difference in time to wound closure) was calculated based on mean intra-individual difference in time to wound closure in 110 participants with missing values replaced by a value of 0, for outcome measure 2 missing values were not replaced. For 2 of the 110 wounds data were missing, thus the reported values are calculated from 108 STSG donor site wound halves by intervention (Oleogel-S10 and non-adhesive wound dressing vs. non-adhesive wound dressing only).
Time Frame 2 to 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) analysis population included all participants who were treated at least once with study medication, i.e. who received any dose of Oleogel-S10 and who had signed an informed consent form. For 2 of the 110 wounds, data were missing, thus the reported values are calculated from 108 STSG donor site wound halves by intervention
Arm/Group Title Oleogel-S10 and Non-adhesive Wound Dressing Non-adhesive Wound Dressing Only
Hide Arm/Group Description:
A split-thickness skin graft (STSG) donor site wound >15cm2 in size was divided in 2 halves. One half of the STSG wound was randomized to Oleogel-S10 treatment plus non-adhesive wound dressing.
A split-thickness skin graft (STSG) donor site wound >15cm2 in size was divided in 2 halves. One half of the STSG wound was randomized to coverage with non-adhesive wound dressing only.
Overall Number of Participants Analyzed 110 110
Overall Number of Units Analyzed
Type of Units Analyzed: STSG Wound (Halves)
 108 108
Mean (95% Confidence Interval)
Unit of Measure: Days from surgery until wound closure
15.1
(14.1 to 16.1)
16.0
(14.8 to 17.1)
3.Secondary Outcome
Title Percentage of Participants With Earlier Healing
Hide Description Percentage of participants with earlier healing of wound area treated with Oleogel-S10 and non-adhesive wound dressing compared to non-adhesive wound dressing only
Time Frame 2 to 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) analysis population included all participants who were treated at least once with study medication, i.e. who received any dose of Oleogel-S10 and who had signed an informed consent form.
Arm/Group Title Oleogel-S10 and Non-adhesive Wound Dressing Non-adhesive Wound Dressing Only
Hide Arm/Group Description:
A split-thickness skin graft (STSG) donor site wound >15cm2 in size was divided in 2 halves. One half of the STSG wound was randomized to Oleogel-S10 treatment plus non-adhesive wound dressing.
A split-thickness skin graft (STSG) donor site wound >15cm2 in size was divided in 2 halves. One half of the STSG wound was randomized to coverage with non-adhesive wound dressing only.
Overall Number of Participants Analyzed 110 110
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage with earlier healing
45.5
(35.9 to 55.2)
30.0
(21.6 to 39.5)
4.Secondary Outcome
Title Percentage of Participants With Wound Closure at Different Time Points
Hide Description For separate time points (Day 7, Day 10, Day 14, Day 18, Day 21, and Day 28), the frequencies of wound areas which have reached wound closure were calculated.
Time Frame 2 to 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) analysis population included all participants who were treated at least once with study medication, i.e. who received any dose of Oleogel-S10 and who had signed an informed consent form. Data were missing for n=2 participants at all time points.
Arm/Group Title Oleogel-S10 and Non-adhesive Wound Dressing Non-adhesive Wound Dressing Only
Hide Arm/Group Description:
A split-thickness skin graft (STSG) donor site wound >15cm2 in size was divided in 2 halves. One half of the STSG wound was randomized to Oleogel-S10 treatment plus non-adhesive wound dressing.
A split-thickness skin graft (STSG) donor site wound >15cm2 in size was divided in 2 halves. One half of the STSG wound was randomized to coverage with non-adhesive wound dressing only.
Overall Number of Participants Analyzed 110 110
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage with wound closure
Day 7
2.8
(0.6 to 7.9)
3.7
(1.0 to 9.2)
Day 10
14.8
(8.7 to 22.9)
8.3
(3.9 to 15.2)
Day 14
48.1
(38.4 to 58.0)
48.1
(38.4 to 58.0)
Day 18
79.6
(70.8 to 86.8)
71.3
(61.8 to 79.6)
Day 21
86.1
(78.1 to 92.0)
80.6
(71.8 to 87.5)
Day 28
96.3
(90.8 to 99.0)
91.7
(84.8 to 96.1)
5.Secondary Outcome
Title Percentage of Wound Epithelialization at Different Time Points as Assessed by the Investigator
Hide Description A study team member assessed the progress of wound healing by treatment regimen and noted the degree of epithelialization (expressed in percent of the original wound size) at wound dressing changes on Day 7, Day 10, Day 14, Day 18, Day 21, and Day 28.
Time Frame 2 to 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) analysis population included all participants who were treated at least once with study medication, i.e. who received any dose of Oleogel-S10 and who had signed an informed consent form.
Arm/Group Title Oleogel-S10 and Non-adhesive Wound Dressing Non-adhesive Wound Dressing Only
Hide Arm/Group Description:
A split-thickness skin graft (STSG) donor site wound >15cm2 in size was divided in 2 halves. One half of the STSG wound was randomized to Oleogel-S10 treatment plus non-adhesive wound dressing.
A split-thickness skin graft (STSG) donor site wound >15cm2 in size was divided in 2 halves. One half of the STSG wound was randomized to coverage with non-adhesive wound dressing only.
Overall Number of Participants Analyzed 110 110
Mean (95% Confidence Interval)
Unit of Measure: Area Percent of initial wound size
Day 7
27.4
(21.5 to 33.3)
21.3
(16.4 to 26.3)
Day 10
48.6
(41.6 to 55.6)
42.5
(36.1 to 48.8)
Day 14
80.6
(75.2 to 86.0)
74.9
(68.9 to 81.0)
Day 18
90.9
(87.2 to 94.6)
85.0
(80.3 to 89.9)
Day 21
94.0
(91.0 to 97.1)
88.5
(84.2 to 92.8)
Day 28
96.4
(94.0 to 98.7)
92.8
(89.3 to 96.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Oleogel-S10 and Non-adhesive Wound Dressing, Non-adhesive Wound Dressing Only
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.0005
Comments Day 7
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 6.1
Confidence Interval (2-Sided) 95%
2.7 to 9.4
Parameter Dispersion
Type: Standard Deviation
Value: 17.8
Estimation Comments Mean difference in degree of epithelialization [%] (Oleogel-S10 and non-adhesive wound dressing minus non-adhesive wound dressing only)
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Oleogel-S10 and Non-adhesive Wound Dressing, Non-adhesive Wound Dressing Only
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.0002
Comments Day 10
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 6.2
Confidence Interval (2-Sided) 95%
3.0 to 9.4
Parameter Dispersion
Type: Standard Deviation
Value: 16.9
Estimation Comments Mean difference in degree of epithelialization [%] (Oleogel-S10 and non-adhesive wound dressing minus non-adhesive wound dressing only)
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Oleogel-S10 and Non-adhesive Wound Dressing, Non-adhesive Wound Dressing Only
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.0028
Comments Day 14
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 5.6
Confidence Interval (2-Sided) 95%
2.0 to 9.3
Parameter Dispersion
Type: Standard Deviation
Value: 19.3
Estimation Comments Mean difference in degree of epithelialization [%] (Oleogel-S10 and non-adhesive wound dressing minus non-adhesive wound dressing only)
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Oleogel-S10 and Non-adhesive Wound Dressing, Non-adhesive Wound Dressing Only
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.0009
Comments Day 18
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 5.9
Confidence Interval (2-Sided) 95%
2.5 to 9.3
Parameter Dispersion
Type: Standard Deviation
Value: 18.0
Estimation Comments Mean difference in degree of epithelialization [%] (Oleogel-S10 and non-adhesive wound dressing minus non-adhesive wound dressing only)
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Oleogel-S10 and Non-adhesive Wound Dressing, Non-adhesive Wound Dressing Only
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.0003
Comments Day 21
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 5.6
Confidence Interval (2-Sided) 95%
2.6 to 8.6
Parameter Dispersion
Type: Standard Deviation
Value: 15.8
Estimation Comments Mean difference in degree of epithelialization [%] (Oleogel-S10 and non-adhesive wound dressing minus non-adhesive wound dressing only)
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Oleogel-S10 and Non-adhesive Wound Dressing, Non-adhesive Wound Dressing Only
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.0145
Comments Day 28
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.6
Confidence Interval (2-Sided) 95%
0.7 to 6.4
Parameter Dispersion
Type: Standard Deviation
Value: 15.1
Estimation Comments Mean difference in degree of epithelialization [%] (Oleogel-S10 and non-adhesive wound dressing minus non-adhesive wound dressing only)
6.Secondary Outcome
Title Likert Scale Rating of Efficacy
Hide Description Participants and investigators were asked to grade the efficacy of Oleogel-S10 and non-adhesive wound dressing versus non-adhesive wound dressing only on a 5-point Likert scale (treatment with Oleogel-S10 is much more effective, treatment with Oleogel-S10 is more effective, both treatments have the same efficacy, non-adhesive wound dressing only is more effective, non-adhesive wound dressing only is much more effective).
Time Frame 2 to 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) analysis population included all participants who were treated at least once with study medication, i.e. who received any dose of Oleogel-S10 and who had signed an informed consent form.
Arm/Group Title Investigator Asssessment Day 7 Investigator Assessment Day 14 Investigator Assessment Day 21 Investigator Assessment Day 28 Investigator Assessment End of Treatment Participant Assessment Day 7 Participant Assessment Day 14 Participant Assessment Day 21 Participant Assessment Day 28 Participant Assessment EoT
Hide Arm/Group Description:
Efficacy as assessed by investigator at Day 7
Efficacy as assessed by investigator at Day 14
Efficacy as assessed by investigator at Day 21
Efficacy as assessed by investigator at Day 28
Efficacy as assessed by investigator at End of Treatment (EoT)
Efficacy as assessed by participant at Day 7
Efficacy as assessed by participant at Day 14
Efficacy as assessed by participant at Day 21
Efficacy as assessed by participant at Day 28
Efficacy as assessed by participant at EoT
Overall Number of Participants Analyzed 107 103 101 101 105 110 100 99 98 102
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of efficacy assessments
Oleogel-S10 much more effective
4.7
(1.5 to 10.6)
13.6
(7.6 to 21.8)
16.8
(10.1 to 25.6)
17.8
(10.9 to 26.7)
17.1
(10.5 to 25.7)
7.7
(3.4 to 14.6)
15.0
(8.6 to 23.5)
16.2
(9.5 to 24.9)
15.3
(8.8 to 24.0)
14.7
(8.5 to 23.1)
Oleogel-S10 more effective
44.9
(35.2 to 54.8)
35.0
(25.8 to 45.0)
36.6
(27.3 to 46.8)
33.7
(24.6 to 43.8)
35.2
(26.2 to 45.2)
31.7
(22.9 to 41.6)
36.0
(26.6 to 46.2)
35.4
(26.0 to 45.6)
35.7
(26.3 to 46.0)
36.3
(27.0 to 46.4)
Both treatments same efficacy
40.2
(30.8 to 50.1)
40.8
(31.2 to 50.9)
36.6
(27.3 to 46.8)
37.6
(28.2 to 47.8)
37.1
(27.9 to 47.1)
53.8
(43.8 to 63.7)
38.0
(28.5 to 48.3)
39.4
(29.7 to 49.7)
38.8
(29.1 to 49.2)
39.2
(29.7 to 49.4)
Standard of care (SOC) more effective
9.3
(4.6 to 16.5)
10.7
(5.5 to 18.3)
9.9
(4.9 to 17.5)
9.9
(4.9 to 17.5)
9.5
(4.7 to 16.8)
6.7
(2.7 to 13.4)
11.0
(5.6 to 18.8)
8.1
(3.6 to 15.3)
8.2
(3.6 to 15.5)
7.8
(3.4 to 14.9)
SOC much more effective
0.9
(0.0 to 5.1)
0.0
(0.0 to 0.0)
0.0
(0.0 to 0.0)
1.0
(0.0 to 5.4)
1.0
(0.0 to 5.2)
0.0
(0.0 to 0.0)
0.0
(0.0 to 0.0)
1.0
(0.0 to 5.5)
2.0
(0.2 to 7.2)
2.0
(0.2 to 6.9)
7.Secondary Outcome
Title Cosmetic Outcome at 3 and 12 Months After Surgery, Respectively
Hide Description Blinded photographic evaluation which wound half resembles more closely the surrounding skin with regard to texture, redness, growth of hair, and pigmentation.
Time Frame 3 months and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description

The intent-to-treat (ITT) analysis population included 96 participants for the 3-months follow-up and 65 participants for the 12-months follow-up.

*Note: The assessment for one patient was missing as no photo was not taken at the Month 3 follow-up visit, therefore this outcome measure is based on 95 patients
Arm/Group Title Texture at 3 Months Follow-up Hair Growth at 3 Months Follow-up Pigmentation at 3 Months Follow-up Redness at 3 Months Follow-up Texture at 12 Months Follow-up Hair Growth at 12 Months Follow-up Pigmentation at 12 Months Follow-up Redness at 12 Months Follow-up
Hide Arm/Group Description:
Evaluation of cosmetic outcome with regard to texture at 3 months follow-up
Evaluation of cosmetic outcome with regard to hair growth at 3 months follow-up
Evaluation of cosmetic outcome with regard to pigmentation at 3 months follow-up
Evaluation of cosmetic outcome with regard to redness at 3 months follow-up
Evaluation of cosmetic outcome with regard to texture at 12 months follow-up
Evaluation of cosmetic outcome with regard to hair growth at 12 months follow-up
Evaluation of cosmetic outcome with regard to pigmentation at 12 months follow-up
Evaluation of cosmetic outcome with regard to redness at 12 months follow-up
Overall Number of Participants Analyzed 95 95 95 95 65 65 65 65
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of wounds
Wound half treated with Oleogel-S10
18.9
(11.6 to 28.3)
1.1
(0.0 to 5.7)
32.6
(23.4 to 43.0)
25.3
(16.9 to 35.2)
13.8
(6.5 to 24.7)
0.0
(0.0 to 0.0)
27.7
(17.3 to 40.2)
15.4
(7.6 to 26.5)
Wound half treated with wound dressing only
8.4
(3.7 to 15.9)
0.0
(0.0 to 0.0)
13.7
(7.5 to 22.3)
14.7
(8.3 to 23.5)
3.1
(0.4 to 10.7)
0.0
(0.0 to 0.0)
9.2
(3.5 to 19.0)
4.6
(1.0 to 12.9)
Both equal
71.6
(61.4 to 80.4)
98.9
(94.3 to 100.0)
50.5
(40.1 to 60.9)
56.8
(46.3 to 67.0)
83.1
(71.7 to 91.2)
100.0
(94.5 to 100.0)
60.0
(47.1 to 72.0)
80.0
(68.2 to 88.9)
8.Secondary Outcome
Title Likert Scale Rating of Tolerability
Hide Description Participants and investigators were asked to evaluate the tolerability of Oleogel-S10 and non-adhesive wound dressing versus non-adhesive wound dressing only (standard of care) on a 5-point Likert scale (treatment with Oleogel-S10 is much better tolerated, treatment with Oleogel-S10 is better tolerated, both treatments are equally well tolerated, non-adhesive wound dressing only is better tolerated, non-adhesive wound dressing only is much better tolerated).
Time Frame 2 to 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population (SAF) included all participants who received treatment at least once, i.e. who received any dose of Oleogel-S10 or standard of care (SOC). If the application of any treatment was uncertain, the participant was included in the SAF.
Arm/Group Title Investigator Asssessment Day 7 Investigator Assessment Day 14 Investigator Assessment Day 21 Investigator Assessment Day 28 Investigator Assessment End of Treatment Participant Assessment Day 7 Participant Assessment Day 14 Participant Assessment Day 21 Participant Assessment Day 28 Participant Assessment EoT
Hide Arm/Group Description:
Tolerability as assessed by investigator at Day 7
Tolerability as assessed by investigator at Day 14
Tolerability as assessed by investigator at Day 21
Tolerability as assessed by investigator at Day 28
Tolerability as assessed by investigator at End of Treatment (EoT)
Tolerability as assessed by participant at Day 7
Tolerability as assessed by participant at Day 14
Tolerability as assessed by participant at Day 21
Tolerability as assessed by participant at Day 28
Tolerability as assessed by participant at EoT
Overall Number of Participants Analyzed 112 112 112 112 112 112 112 112 112 112
Measure Type: Number
Unit of Measure: Percentage of participants
Oleogeogel-S10 much better tolerated 5.4 8.9 11.6 12.5 13.4 8.0 13.4 16.1 15.2 16.1
Oleogel-S10 better tolerated 30.4 33.9 28.6 26.8 28.9 23.2 29.5 26.8 25.9 27.7
Both treatments equally well tolerated 58.9 44.6 46.4 48.2 49.1 58.0 37.5 37.5 40.2 41.1
SOC better tolerated 2.7 5.4 3.6 3.6 3.6 3.6 8.9 7.1 5.4 5.4
SOC much better tolerated 0.0 0.0 0.9 0.0 0.0 0.0 0.0 0.9 0.9 0.9
9.Secondary Outcome
Title Pharmacokinetic (PK) Data (Number of Plasma Samples With Measurable Betulin Concentration)
Hide Description Systemic presence/concentration of betulin in blood plasma samples. Plasma samples were collected in weekly intervals and at the end of treatment (when wound closure was achieved or at Day 28). Samples were analysed in a central laboratory with a validated LC-MS/MS method with a lower limit of quantification (LLOQ) of 1 ng/mL.
Time Frame up to 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population included all participants who received treatment at least once, i.e. who received any dose of Oleogel-S10 or standard of care (SOC). If the application of any treatment was uncertain, the participant was included in the SAF.
Arm/Group Title Day 0 (Pre-dose) Treatment Period
Hide Arm/Group Description:
Plasma samples collected at the day of STSG surgery prior to first treatment with study medication
Plasma samples collected at Day 7, Day 14, Day 21 or at end of treatment (day of wound closure or Day 28)
Overall Number of Participants Analyzed 112 112
Overall Number of Units Analyzed
Type of Units Analyzed: Plasma Samples
 112 290
Measure Type: Number
Unit of Measure: Plasma Samples
Samples below LLOQ (<1 ng/mL) 110 271
Samples above LLOQ 2 13
Samples without valid result 0 6
10.Secondary Outcome
Title Pharmacokinetic (PK) Data (Plasma Betulin Concentration)
Hide Description Systemic presence/concentration of betulin in blood plasma samples - values for the number of samples with measurable values in samples above the lower limit of quantification (LLOQ) of 1 ng/mL
Time Frame up to 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 13 participants had a total of 15 samples with betulin concentrations above the LLOQ (1 ng/mL), 2 participants with 2 samples each above LLOQ
Arm/Group Title Day 0 (Pre-dose) Treatment Period
Hide Arm/Group Description:
Plasma samples collected at the day of STSG surgery prior to first treatment with study medication
Plasma samples collected at Day 7, Day 14, Day 21 or at end of treatment (day of wound closure or Day 28)
Overall Number of Participants Analyzed 112 112
Overall Number of Units Analyzed
Type of Units Analyzed: Samples above LLOQ
 2 13
Mean (Full Range)
Unit of Measure: Betulin (ng/mL)
24.0
(4.1 to 43.9)
10.4
(1.1 to 68.6)
11.Secondary Outcome
Title Frequency of Adverse Events
Hide Description [Not Specified]
Time Frame Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population included all participants who received treatment at least once, i.e. who received any dose of Oleogel-S10 or standard of care (SOC). If the application of any treatment was uncertain, the participant was included in the SAF.
Arm/Group Title Entire Study Population
Hide Arm/Group Description:
All participants who were randomized and treated with Oleogel-S10 and non-adhesive wound dressing and/or non-adhesive wound dressing only.
Overall Number of Participants Analyzed 112
Measure Type: Number
Unit of Measure: Participants with adverse events (%)
Adverse events (AEs) 53.6
Serious adverse events 4.5
AEs leading to discontinuation 3.6
Related AEs 14.3
Application site reactions 24.1
Non treatment-emergent AEs 7.1
12.Secondary Outcome
Title Severity of Adverse Events
Hide Description Adverse Events were graded according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) as being mild (NCI CTCAE Grade 1), moderate (NCI CTCAE Grade 2), severe (NCI CTCAE Grade 3), life-threatening (NCI CTCAE Grade 4) or death (NCI CTCAE Grade 5).
Time Frame Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population included all participants who received treatment at least once, i.e. who received any dose of Oleogel-S10 or standard of care (SOC). If the application of any treatment was uncertain, the participant was included in the SAF.
Arm/Group Title Entire Study Population
Hide Arm/Group Description:
All participants who were randomized and treated with Oleogel-S10 and non-adhesive wound dressing and/or non-adhesive wound dressing only.
Overall Number of Participants Analyzed 112
Measure Type: Number
Unit of Measure: Participants with adverse events (%)
Mild (CTCAE Grade 1) 40.2
Moderate (CTCAE Grade 2) 27.7
Severe (CTCAE Grade 3) 7.1
Life-Threatening (CTCAE Grade 4) 2.7
Death (CTCAE Grade 5) 0.0
13.Secondary Outcome
Title Adverse Events by Relationship to Study Medication
Hide Description Adverse events were assessed as being 'unlikely', 'possibly' or 'probably' related to study medication, 'not related' to study medication or the relationship to study medication was rated as 'unknown'.
Time Frame Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population included all participants who received treatment at least once, i.e. who received any dose of Oleogel-S10 or standard of care (SOC). If the application of any treatment was uncertain, the participant was included in the SAF.
Arm/Group Title Entire Study Population
Hide Arm/Group Description:
All participants who were randomized and treated with Oleogel-S10 and non-adhesive wound dressing and/or non-adhesive wound dressing only.
Overall Number of Participants Analyzed 112
Measure Type: Number
Unit of Measure: Participants with adverse events (%)
'Unlikely' related 2.7
'Possibly' related 5.4
'Probably' related 8.0
Unknown relationship 1.8
No relationship 47.3
Time Frame Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Entire Study Population - Systemic Adverse Events (AE) Oleogel-S10 Localized Adverse Event (AE) Non-adhesive Wound Dressing Localized AE Localized AE Both Wound Halves Entire Study Population -Systemic and Localized AEs
Hide Arm/Group Description All participants treated with Oleogel-S10 and non-adhesive wound dressing and/or non-adhesive wound dressing only. AEs not localized to any wound application site by the investigator are reported in this arm. All participants treated with Oleogel-S10 and non-adhesive wound dressing and/or non-adhesive wound dressing only. Application site reactions as judged by the investigator which occurred only at the Oleogel-S10 wound half are reported in this arm. All participants treated with Oleogel-S10 and non-adhesive wound dressing and/or non-adhesive wound dressing only. Application site reactions as judged by the investigator which occurred only at the wound half treated with non-adhesive wound dressing only are reported in this arm. All participants treated with Oleogel-S10 and non-adhesive wound dressing and non-adhesive wound dressing only. Application site reactions as judged by the investigator which occurred at both the Oleogel-S10 wound half and the non-adhesive wound dressing only half in one participant are reported in this arm. All participants treated with Oleogel-S10 and non-adhesive wound dressing and/or non-adhesive wound dressing only. Local and systemic AEs are reported in this arm.
All-Cause Mortality
Entire Study Population - Systemic Adverse Events (AE) Oleogel-S10 Localized Adverse Event (AE) Non-adhesive Wound Dressing Localized AE Localized AE Both Wound Halves Entire Study Population -Systemic and Localized AEs
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Entire Study Population - Systemic Adverse Events (AE) Oleogel-S10 Localized Adverse Event (AE) Non-adhesive Wound Dressing Localized AE Localized AE Both Wound Halves Entire Study Population -Systemic and Localized AEs
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/112 (3.57%)      0/112 (0.00%)      0/112 (0.00%)      1/112 (0.89%)      5/112 (4.46%)    
Infections and infestations           
Wound infection † 1  0/112 (0.00%)  0 0/112 (0.00%)  0 0/112 (0.00%)  0 1/112 (0.89%)  1 1/112 (0.89%)  1
Sepsis † 1  1/112 (0.89%)  1 0/112 (0.00%)  0 0/112 (0.00%)  0 0/112 (0.00%)  0 1/112 (0.89%)  1
Bacteremia † 1  1/112 (0.89%)  1 0/112 (0.00%)  0 0/112 (0.00%)  0 0/112 (0.00%)  0 1/112 (0.89%)  1
Injury, poisoning and procedural complications           
Postoperative wound complication † 1 [1]  1/112 (0.89%)  1 0/112 (0.00%)  0 0/112 (0.00%)  0 0/112 (0.00%)  0 1/112 (0.89%)  1
Psychiatric disorders           
Mania † 1  1/112 (0.89%)  1 0/112 (0.00%)  0 0/112 (0.00%)  0 0/112 (0.00%)  0 1/112 (0.89%)  1
Respiratory, thoracic and mediastinal disorders           
Bronchospasm † 1  1/112 (0.89%)  1 0/112 (0.00%)  0 0/112 (0.00%)  0 0/112 (0.00%)  0 1/112 (0.89%)  1
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
[1]
Post-operative wound necrosis on the site of a flap intake on the right leg
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Entire Study Population - Systemic Adverse Events (AE) Oleogel-S10 Localized Adverse Event (AE) Non-adhesive Wound Dressing Localized AE Localized AE Both Wound Halves Entire Study Population -Systemic and Localized AEs
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   30/112 (26.79%)      2/112 (1.79%)      4/112 (3.57%)      9/112 (8.04%)      40/112 (35.71%)    
Blood and lymphatic system disorders           
Anemia † 1  6/112 (5.36%)  6 0/112 (0.00%)  0 0/112 (0.00%)  0 0/112 (0.00%)  0 6/112 (5.36%)  6
Gastrointestinal disorders           
Constipation † 1  8/112 (7.14%)  8 0/112 (0.00%)  0 0/112 (0.00%)  0 0/112 (0.00%)  0 8/112 (7.14%)  8
General disorders           
Pain † 1  6/112 (5.36%)  6 0/112 (0.00%)  0 0/112 (0.00%)  0 0/112 (0.00%)  0 6/112 (5.36%)  6
Pyrexia † 1  12/112 (10.71%)  13 0/112 (0.00%)  0 0/112 (0.00%)  0 0/112 (0.00%)  0 12/112 (10.71%)  13
Infections and infestations           
Skin infection † 1  2/112 (1.79%)  2 1/112 (0.89%)  1 2/112 (1.79%)  2 4/112 (3.57%)  4 9/112 (8.04%)  9
Skin and subcutaneous tissue disorders           
Pain of skin † 1  4/112 (3.57%)  4 0/112 (0.00%)  0 2/112 (1.79%)  2 4/112 (3.57%)  4 10/112 (8.93%)  10
Pruritus † 1  5/112 (4.46%)  5 1/112 (0.89%)  1 0/112 (0.00%)  0 3/112 (2.68%)  3 9/112 (8.04%)  9
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Publication requires approval of the sponsor without specification of an embargo time period.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Head of Clinical Development
Organization: Amryt Pharma
Phone: +353 1 518 0200
EMail: medinfo@amrytpharma.com
Publications:
Layout table for additonal information
Responsible Party: Amryt Pharma ( Birken AG )
ClinicalTrials.gov Identifier: NCT01807650     History of Changes
Other Study ID Numbers: BSG-12
2012-003390-26 ( EudraCT Number )
First Submitted: March 5, 2013
First Posted: March 8, 2013
Results First Submitted: July 18, 2016
Results First Posted: July 19, 2018
Last Update Posted: July 19, 2018