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Trial record 7 of 7 for:    oleogel-s10

The Efficacy and Tolerability of Oleogel-S-10 in Patients With Actinic Keratoses

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ClinicalTrials.gov Identifier: NCT00786994
Recruitment Status : Completed
First Posted : November 6, 2008
Results First Posted : August 14, 2015
Last Update Posted : September 14, 2015
Sponsor:
Collaborator:
University Hospital Tuebingen
Information provided by (Responsible Party):
Amryt Pharma ( Birken AG )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Actinic Keratoses
Interventions Drug: Oleogel-S10 100 mg/g
Drug: Placebo (petroleum jelly)
Enrollment 165
Recruitment Details 165 patients were recruited.
Pre-assignment Details 157 patients were evaluated in the ITT population. 8 of 165 recruited patients were excluded from ITT evaluation due to a deviation from the inclusion and exclusion criteria. For safety evaluations, all 165 patients had received treatment with study medication and all 165 patients were assessed for adverse events.
Arm/Group Title A - Oleogel-S10 Once Daily B - Oleogel-S10 Twice Daily C - Placebo Once Daily D - Placebo Twice Daily
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Oleogel-S10 ointment for three months once a day (54 patients)

Oleogel-S10: topical use once or twice daily

Oleogel-S10 vehicle for three months twice a day (54 patients)

Oleogel-S10: topical use once or twice daily

Placebo (petroleum jelly) for three months once a day (27 patients)

Placebo (petroleum jelly)

Placebo (petroleum jelly) for three months twice a day (27 patients)

Placebo (petroleum jelly)

Period Title: Overall Study
Started 57 54 26 28
ITT 53 51 25 28
Completed 47 39 24 22
Not Completed 10 15 2 6
Arm/Group Title A - Oleogel-S10 Once Daily B - Oleogel-S10 Twice Daily C - Placebo Once Daily D - Placebo Twice Daily Total
Hide Arm/Group Description

Oleogel-S10 ointment for three months once a day (54 patients)

Oleogel-S10: topical use once or twice daily

Oleogel-S10 vehicle for three months twice a day (54 patients)

Oleogel-S10: topical use once or twice daily

Placebo (petroleum jelly) for three months once a day (27 patients)

Placebo (petroleum jelly)

Placebo (petroleum jelly) for three months twice a day (27 patients)

Placebo (petroleum jelly)

Total of all reporting groups
Overall Number of Baseline Participants 53 51 25 28 157
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ITT
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 53 participants 51 participants 25 participants 28 participants 157 participants
72
(61 to 88)
74
(56 to 85)
69
(57 to 81)
72
(51 to 83)
72
(51 to 88)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 51 participants 25 participants 28 participants 157 participants
Female
41
  77.4%
42
  82.4%
20
  80.0%
25
  89.3%
128
  81.5%
Male
12
  22.6%
9
  17.6%
5
  20.0%
3
  10.7%
29
  18.5%
Actinic keratosis baseline severity index  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 53 participants 51 participants 25 participants 28 participants 157 participants
Mild 22 18 9 13 62
Moderate 31 33 16 15 95
Histopathological grading  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 53 participants 51 participants 25 participants 28 participants 157 participants
Grade I 9 4 2 2 17
Grade II 11 10 4 12 37
Grade III 32 36 19 13 100
not done 1 1 0 1 3
1.Primary Outcome
Title Objective Response of the Marker Actinic Keratosis, Defined as Histologically Complete or Partial Clearance.
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Objective response of the marker actinic keratosis, defined as histologically complete or partial clearance (partial clearance = down-grading in Cockerell-classification). The marker actinic keratosis is defined as an initially selected lesion within the target area that will be used for final biopsy.

The Cockerell classification refers to a single lesion, graded as the presence of atypical cells in the lower third of the epidermis (grade I), involvement of at least the lower two-thirds (grade II) or atypical keratinocytic proliferation in the entire epidermis (grade III). Thus a down-grading from a higher Cockerell grade (e.g., III) to a lower Cockerell grade (e.g., I) represents a positive outcome and treatment success.

Time Frame 18 weeks
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title A - Oleogel-S10 Once Daily B - Oleogel-S10 Twice Daily C/D - Placebo Once or Twice Daily
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Oleogel-S10 ointment for three months once a day

Oleogel-S10: topical use once or twice daily

Oleogel-S10 vehicle for three months twice a day

Oleogel-S10: topical use once or twice daily

Placebo (petroleum jelly) for three months once or twice a day

Placebo (petroleum jelly)

Overall Number of Participants Analyzed 47 39 46
Measure Type: Number
Unit of Measure: participants
Success: Downgrading or clearance 22 17 19
Failure: No downgrading or clearance 25 22 27
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A - Oleogel-S10 Once Daily, C/D - Placebo Once or Twice Daily
Comments A vs C/D
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.60
Comments [Not Specified]
Method Mantel Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection B - Oleogel-S10 Twice Daily, C/D - Placebo Once or Twice Daily
Comments B vs. C/D
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.83
Comments [Not Specified]
Method Mantel Haenszel
Comments [Not Specified]
Time Frame Treatment period of 18 weeks: Visits at 0, 6, 12 and 18 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title A - Oleogel-S10 Once Daily B - Oleogel-S10 Twice Daily C - Placebo Once Daily D - Placebo Twice Daily
Hide Arm/Group Description

Oleogel-S10 ointment for three months once a day

Oleogel-S10: topical use once or twice daily

Oleogel-S10 vehicle for three months twice a day

Oleogel-S10: topical use once or twice daily

Placebo (petroleum jelly) for three months once a day

Placebo (petroleum jelly)

Placebo (petroleum jelly) for three months twice a day

Placebo (petroleum jelly)

All-Cause Mortality
A - Oleogel-S10 Once Daily B - Oleogel-S10 Twice Daily C - Placebo Once Daily D - Placebo Twice Daily
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
A - Oleogel-S10 Once Daily B - Oleogel-S10 Twice Daily C - Placebo Once Daily D - Placebo Twice Daily
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/57 (3.51%)      3/54 (5.56%)      0/26 (0.00%)      0/28 (0.00%)    
Infections and infestations         
Respiratory infection   1/57 (1.75%)  1 0/54 (0.00%)  0 0/26 (0.00%)  0 0/28 (0.00%)  0
Injury, poisoning and procedural complications         
Fracture of rib   1/57 (1.75%)  1 0/54 (0.00%)  0 0/26 (0.00%)  0 0/28 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Prolaps of intervertebral disc   0/57 (0.00%)  0 1/54 (1.85%)  1 0/26 (0.00%)  0 0/28 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Cholangiocarcinoma   0/57 (0.00%)  0 1/54 (1.85%)  1 0/26 (0.00%)  0 0/28 (0.00%)  0
Basal cell carcinoma   0/57 (0.00%)  0 1/54 (1.85%)  1 0/26 (0.00%)  0 0/28 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
A - Oleogel-S10 Once Daily B - Oleogel-S10 Twice Daily C - Placebo Once Daily D - Placebo Twice Daily
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/57 (5.26%)      7/54 (12.96%)      3/26 (11.54%)      3/28 (10.71%)    
Gastrointestinal disorders         
Gastritis (including bile reflux gastritis)   2/57 (3.51%)  2 0/54 (0.00%)  0 0/26 (0.00%)  0 0/28 (0.00%)  0
Immune system disorders         
Allergic reaction/hypersensitivity (including drug fever)   0/57 (0.00%)  0 0/54 (0.00%)  0 1/26 (3.85%)  1 0/28 (0.00%)  0
Infections and infestations         
Flu-like syndrome   0/57 (0.00%)  0 2/54 (3.70%)  2 0/26 (0.00%)  0 1/28 (3.57%)  1
Cough / upper respiratory tract infection   2/57 (3.51%)  2 0/54 (0.00%)  0 0/26 (0.00%)  0 0/28 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Basal cell carcinoma   0/57 (0.00%)  0 1/54 (1.85%)  1 0/26 (0.00%)  0 2/28 (7.14%)  2
Skin and subcutaneous tissue disorders         
Rash   0/57 (0.00%)  0 3/54 (5.56%)  3 1/26 (3.85%)  1 0/28 (0.00%)  0
Pruritus   0/57 (0.00%)  0 1/54 (1.85%)  4 1/26 (3.85%)  1 0/28 (0.00%)  0
Indicates events were collected by systematic assessment
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.
Agreement on publication prior to disclosure
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Annette Pflugfelder
Organization: Center for Dermatooncology, Department of Dermatology, University Hospital Tübingen, Tübingen, Germany
EMail: annette.pflugfelder@med.uni-tuebingen.de
Layout table for additonal information
Responsible Party: Amryt Pharma ( Birken AG )
ClinicalTrials.gov Identifier: NCT00786994     History of Changes
Other Study ID Numbers: BAK-08
First Submitted: November 5, 2008
First Posted: November 6, 2008
Results First Submitted: April 2, 2015
Results First Posted: August 14, 2015
Last Update Posted: September 14, 2015