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Oleogel-S10 Versus Standard of Care in Healing of Grade 2a Burn Wounds

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ClinicalTrials.gov Identifier: NCT01657292
Recruitment Status : Completed
First Posted : August 6, 2012
Results First Posted : September 28, 2015
Last Update Posted : September 28, 2015
Sponsor:
Information provided by (Responsible Party):
Amryt Pharma ( Birken AG )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Burns
Interventions Drug: Oleogel-S10 ointment
Device: Octenilin® wound gel
Enrollment 61
Recruitment Details Study participants were enrolled from 31-Aug-2012 to 10-Jul-2013, in 10 clinical centres in 4 countries: Germany (4 centers), Uk (3 centers), Sweden (2 centers), and Switzerland (1 center).
Pre-assignment Details 66 patients were screened of which 5 violated eligibility criteria and thus 61 subjects were treated.
Arm/Group Title Entire Study Population
Hide Arm/Group Description All patients treated with Oleogel-S10 and Octenilin® wound gel.
Period Title: Overall Study
Started 61
Completed 51
Not Completed 10
Reason Not Completed
Adverse Event             6
Withdrawal by Subject             2
Violation of eligibility criteria             1
Change of therapy             1
Arm/Group Title Entire Study Population
Hide Arm/Group Description All patients treated with Oleogel-S10 and Octenilin® wound gel.
Overall Number of Baseline Participants 61
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants
<=18 years
1
   1.6%
Between 18 and 65 years
54
  88.5%
>=65 years
6
   9.8%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 61 participants
41
(18 to 79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants
Female
19
  31.1%
Male
42
  68.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 61 participants
Sweden 3
United Kingdom 28
Switzerland 4
Germany 26
1.Primary Outcome
Title Percentage of Patients With Earlier Healing of the Wound Half Treated With Oleogel-S10 Compared to the Wound Half Receiving Standard of Care
Hide Description Photo-based evaluation by independent experts blinded to the treatment regime.
Time Frame 2 to 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis included all patients who were treated at least once with Oleogel-S10 or Octenilin® wound gel (as randomised) and for whom a difference in wound healing between the treatment was observed.
Arm/Group Title Entire Study Population
Hide Arm/Group Description:
All patients treated with Oleogel-S10 and Octenilin® wound gel.
Overall Number of Participants Analyzed 35
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
85.7
(69.7 to 95.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Entire Study Population
Comments

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

Hypotheses tested: H0: s0 ≤0.5 and H1: s0 >0.5 (with s0=rate of superiority of Oleogel-S10).

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments 1-sided, significance level = 0.025
Method Binomial test
Comments [Not Specified]
2.Secondary Outcome
Title Intra-individual Difference in Time to Wound Closure Between Wound Halves, Either Treated With Oleogel-S10 or Treated With Standard of Care
Hide Description [Not Specified]
Time Frame 2 to 3 weeks
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Time From Study Start After Burn Accident Until Wound Closure is Achieved Separately for Wound Halves Treated With Oleogel-S10 vs. Standard of Care
Hide Description [Not Specified]
Time Frame 2 to 3 weeks
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Percentage of Patients With Wound Closure at Different Time Points
Hide Description [Not Specified]
Time Frame 2 to 3 weeks
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Percentage of Wound Epithelialization at Different Time Points as Assessed by the Investigator
Hide Description [Not Specified]
Time Frame 2 to 3 weeks
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Likert Scale Rating of Efficacy (Evaluated by Both the Investigators and Patients)
Hide Description By direct comparison of the separate simultaneous treatments for the two wound halves, patients and investigators, respectively, are asked to grade the efficacy of Oleogel-S10 Versus Standard of Care on a questionnaire with a 5-point graded visual analogue scale
Time Frame 2 to 3 weeks
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Cosmetic Outcome After 3 and 12 Months After Burn Accident, in Relation to Texture, Redness, Growth of Hair and Pigmentation, Based on Blinded Photo Evaluation
Hide Description [Not Specified]
Time Frame 3 and 12 months
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Likert Scale Rating of Tolerance (Evaluated by Both the Investigators and Patients)
Hide Description By direct comparison of the separate simultaneous treatments for the two wound halves, patients and investigators, respectively, are asked to provide their opinion on the tolerance of Oleogel-S10 Versus Standard of Care on a questionnaire with a 5-point graded visual analogue scale
Time Frame 2 to 3 weeks
Outcome Measure Data Not Reported
9.Secondary Outcome
Title PK Data: Systemic Presence/Concentration of Betulin in Blood Plasma Samples
Hide Description [Not Specified]
Time Frame 2 to 3 weeks
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Microbial Colonization of the Wound Halves
Hide Description [Not Specified]
Time Frame 2 to 3 weeks
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Assessment of Adverse Events
Hide Description [Not Specified]
Time Frame 2 to 3 weeks
Outcome Measure Data Not Reported
Time Frame Day 0 (start of treatment) till end of treatment (Day 21 or earlier if full wound closure was achieved earlier, or later, if the investigator decided to change medication and/or treatment due to unsatisfying wound closure after Day 21).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Entire Study Population - Systemic AEs Oleogel-S10 Localized AE Octenilin Localized AE Localized AE Both Wound Halves
Hide Arm/Group Description All patients treated with Oleogel-S10 and Octenilin® wound gel. Systemic AEs which are not localized to the wound application site are reported under this arm. All patients treated with Oleogel-S10 and Octenilin® wound gel. Application site reactions which occurred only at the Oleogel-S10 wound half are reported under this arm. All patients treated with Oleogel-S10 and Octenilin® wound gel. Application site reactions which occurred only at the Octenilin® wound half are reported under this arm. All patients treated with Oleogel-S10 and Octenilin® wound gel. Application site reactions which occurred at both the Octenilin® wound half and Oleogel-S10 wound half in one patient are reported under this arm.
All-Cause Mortality
Entire Study Population - Systemic AEs Oleogel-S10 Localized AE Octenilin Localized AE Localized AE Both Wound Halves
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 AEs Oleogel-S10 Localized AE Octenilin Localized AE Localized AE Both Wound Halves
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/61 (3.28%)   1/61 (1.64%)   1/61 (1.64%)   4/61 (6.56%) 
General disorders         
Condition aggravated  1 [1]  0/61 (0.00%)  0/61 (0.00%)  0/61 (0.00%)  2/61 (3.28%) 
Pyrexia  1  1/61 (1.64%)  0/61 (0.00%)  0/61 (0.00%)  0/61 (0.00%) 
Infections and infestations         
Soft tissue infection  1  0/61 (0.00%)  0/61 (0.00%)  1/61 (1.64%)  0/61 (0.00%) 
Wound infection  1  0/61 (0.00%)  0/61 (0.00%)  0/61 (0.00%)  2/61 (3.28%) 
Injury, poisoning and procedural complications         
Wound necrosis  1  0/61 (0.00%)  1/61 (1.64%)  0/61 (0.00%)  0/61 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Tonsil cancer  1  1/61 (1.64%)  0/61 (0.00%)  0/61 (0.00%)  0/61 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (15.1)
[1]
Further deepening of burn wound
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 AEs Oleogel-S10 Localized AE Octenilin Localized AE Localized AE Both Wound Halves
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/61 (0.00%)   0/61 (0.00%)   0/61 (0.00%)   0/61 (0.00%) 
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 pharmaceutical development
Organization: Birken AG
Phone: +49 7233 97490
EMail: t.zahn@birken.eu
Layout table for additonal information
Responsible Party: Amryt Pharma ( Birken AG )
ClinicalTrials.gov Identifier: NCT01657292     History of Changes
Other Study ID Numbers: BBW-11
2012-000362-38 ( EudraCT Number )
First Submitted: July 29, 2012
First Posted: August 6, 2012
Results First Submitted: July 31, 2015
Results First Posted: September 28, 2015
Last Update Posted: September 28, 2015