Trial Outcomes & Findings for The Efficacy and Tolerability of Oleogel-S-10 in Patients With Actinic Keratoses (NCT NCT00786994)
NCT ID: NCT00786994
Last Updated: 2015-09-14
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
165 participants
Primary outcome timeframe
18 weeks
Results posted on
2015-09-14
Participant Flow
165 patients were recruited.
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.
Participant milestones
| Measure |
A - Oleogel-S10 Once Daily
Oleogel-S10 ointment for three months once a day (54 patients)
Oleogel-S10: topical use once or twice daily
|
B - Oleogel-S10 Twice Daily
Oleogel-S10 vehicle for three months twice a day (54 patients)
Oleogel-S10: topical use once or twice daily
|
C - Placebo Once Daily
Placebo (petroleum jelly) for three months once a day (27 patients)
Placebo (petroleum jelly)
|
D - Placebo Twice Daily
Placebo (petroleum jelly) for three months twice a day (27 patients)
Placebo (petroleum jelly)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
57
|
54
|
26
|
28
|
|
Overall Study
ITT
|
53
|
51
|
25
|
28
|
|
Overall Study
COMPLETED
|
47
|
39
|
24
|
22
|
|
Overall Study
NOT COMPLETED
|
10
|
15
|
2
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Efficacy and Tolerability of Oleogel-S-10 in Patients With Actinic Keratoses
Baseline characteristics by cohort
| Measure |
A - Oleogel-S10 Once Daily
n=53 Participants
Oleogel-S10 ointment for three months once a day (54 patients)
Oleogel-S10: topical use once or twice daily
|
B - Oleogel-S10 Twice Daily
n=51 Participants
Oleogel-S10 vehicle for three months twice a day (54 patients)
Oleogel-S10: topical use once or twice daily
|
C - Placebo Once Daily
n=25 Participants
Placebo (petroleum jelly) for three months once a day (27 patients)
Placebo (petroleum jelly)
|
D - Placebo Twice Daily
n=28 Participants
Placebo (petroleum jelly) for three months twice a day (27 patients)
Placebo (petroleum jelly)
|
Total
n=157 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
72 years
n=99 Participants
|
74 years
n=107 Participants
|
69 years
n=206 Participants
|
72 years
n=7 Participants
|
72 years
n=31 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
25 Participants
n=7 Participants
|
128 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
29 Participants
n=31 Participants
|
|
Actinic keratosis baseline severity index
Mild
|
22 participants
n=99 Participants
|
18 participants
n=107 Participants
|
9 participants
n=206 Participants
|
13 participants
n=7 Participants
|
62 participants
n=31 Participants
|
|
Actinic keratosis baseline severity index
Moderate
|
31 participants
n=99 Participants
|
33 participants
n=107 Participants
|
16 participants
n=206 Participants
|
15 participants
n=7 Participants
|
95 participants
n=31 Participants
|
|
Histopathological grading
Grade I
|
9 participants
n=99 Participants
|
4 participants
n=107 Participants
|
2 participants
n=206 Participants
|
2 participants
n=7 Participants
|
17 participants
n=31 Participants
|
|
Histopathological grading
Grade II
|
11 participants
n=99 Participants
|
10 participants
n=107 Participants
|
4 participants
n=206 Participants
|
12 participants
n=7 Participants
|
37 participants
n=31 Participants
|
|
Histopathological grading
Grade III
|
32 participants
n=99 Participants
|
36 participants
n=107 Participants
|
19 participants
n=206 Participants
|
13 participants
n=7 Participants
|
100 participants
n=31 Participants
|
|
Histopathological grading
not done
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
0 participants
n=206 Participants
|
1 participants
n=7 Participants
|
3 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 18 weeksObjective 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.
Outcome measures
| Measure |
A - Oleogel-S10 Once Daily
n=47 Participants
Oleogel-S10 ointment for three months once a day
Oleogel-S10: topical use once or twice daily
|
B - Oleogel-S10 Twice Daily
n=39 Participants
Oleogel-S10 vehicle for three months twice a day
Oleogel-S10: topical use once or twice daily
|
C/D - Placebo Once or Twice Daily
n=46 Participants
Placebo (petroleum jelly) for three months once or twice a day
Placebo (petroleum jelly)
|
|---|---|---|---|
|
Objective Response of the Marker Actinic Keratosis, Defined as Histologically Complete or Partial Clearance.
Success: Downgrading or clearance
|
22 participants
|
17 participants
|
19 participants
|
|
Objective Response of the Marker Actinic Keratosis, Defined as Histologically Complete or Partial Clearance.
Failure: No downgrading or clearance
|
25 participants
|
22 participants
|
27 participants
|
Adverse Events
A - Oleogel-S10 Once Daily
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
B - Oleogel-S10 Twice Daily
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
C - Placebo Once Daily
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
D - Placebo Twice Daily
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
A - Oleogel-S10 Once Daily
n=57 participants at risk
Oleogel-S10 ointment for three months once a day
Oleogel-S10: topical use once or twice daily
|
B - Oleogel-S10 Twice Daily
n=54 participants at risk
Oleogel-S10 vehicle for three months twice a day
Oleogel-S10: topical use once or twice daily
|
C - Placebo Once Daily
n=26 participants at risk
Placebo (petroleum jelly) for three months once a day
Placebo (petroleum jelly)
|
D - Placebo Twice Daily
n=28 participants at risk
Placebo (petroleum jelly) for three months twice a day
Placebo (petroleum jelly)
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Fracture of rib
|
1.8%
1/57 • Number of events 1 • Treatment period of 18 weeks: Visits at 0, 6, 12 and 18 weeks
|
0.00%
0/54 • Treatment period of 18 weeks: Visits at 0, 6, 12 and 18 weeks
|
0.00%
0/26 • Treatment period of 18 weeks: Visits at 0, 6, 12 and 18 weeks
|
0.00%
0/28 • Treatment period of 18 weeks: Visits at 0, 6, 12 and 18 weeks
|
|
Infections and infestations
Respiratory infection
|
1.8%
1/57 • Number of events 1 • Treatment period of 18 weeks: Visits at 0, 6, 12 and 18 weeks
|
0.00%
0/54 • Treatment period of 18 weeks: Visits at 0, 6, 12 and 18 weeks
|
0.00%
0/26 • Treatment period of 18 weeks: Visits at 0, 6, 12 and 18 weeks
|
0.00%
0/28 • Treatment period of 18 weeks: Visits at 0, 6, 12 and 18 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.00%
0/57 • Treatment period of 18 weeks: Visits at 0, 6, 12 and 18 weeks
|
1.9%
1/54 • Number of events 1 • Treatment period of 18 weeks: Visits at 0, 6, 12 and 18 weeks
|
0.00%
0/26 • Treatment period of 18 weeks: Visits at 0, 6, 12 and 18 weeks
|
0.00%
0/28 • Treatment period of 18 weeks: Visits at 0, 6, 12 and 18 weeks
|
|
Musculoskeletal and connective tissue disorders
Prolaps of intervertebral disc
|
0.00%
0/57 • Treatment period of 18 weeks: Visits at 0, 6, 12 and 18 weeks
|
1.9%
1/54 • Number of events 1 • Treatment period of 18 weeks: Visits at 0, 6, 12 and 18 weeks
|
0.00%
0/26 • Treatment period of 18 weeks: Visits at 0, 6, 12 and 18 weeks
|
0.00%
0/28 • Treatment period of 18 weeks: Visits at 0, 6, 12 and 18 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/57 • Treatment period of 18 weeks: Visits at 0, 6, 12 and 18 weeks
|
1.9%
1/54 • Number of events 1 • Treatment period of 18 weeks: Visits at 0, 6, 12 and 18 weeks
|
0.00%
0/26 • Treatment period of 18 weeks: Visits at 0, 6, 12 and 18 weeks
|
0.00%
0/28 • Treatment period of 18 weeks: Visits at 0, 6, 12 and 18 weeks
|
Other adverse events
| Measure |
A - Oleogel-S10 Once Daily
n=57 participants at risk
Oleogel-S10 ointment for three months once a day
Oleogel-S10: topical use once or twice daily
|
B - Oleogel-S10 Twice Daily
n=54 participants at risk
Oleogel-S10 vehicle for three months twice a day
Oleogel-S10: topical use once or twice daily
|
C - Placebo Once Daily
n=26 participants at risk
Placebo (petroleum jelly) for three months once a day
Placebo (petroleum jelly)
|
D - Placebo Twice Daily
n=28 participants at risk
Placebo (petroleum jelly) for three months twice a day
Placebo (petroleum jelly)
|
|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/57 • Treatment period of 18 weeks: Visits at 0, 6, 12 and 18 weeks
|
1.9%
1/54 • Number of events 1 • Treatment period of 18 weeks: Visits at 0, 6, 12 and 18 weeks
|
0.00%
0/26 • Treatment period of 18 weeks: Visits at 0, 6, 12 and 18 weeks
|
7.1%
2/28 • Number of events 2 • Treatment period of 18 weeks: Visits at 0, 6, 12 and 18 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/57 • Treatment period of 18 weeks: Visits at 0, 6, 12 and 18 weeks
|
5.6%
3/54 • Number of events 3 • Treatment period of 18 weeks: Visits at 0, 6, 12 and 18 weeks
|
3.8%
1/26 • Number of events 1 • Treatment period of 18 weeks: Visits at 0, 6, 12 and 18 weeks
|
0.00%
0/28 • Treatment period of 18 weeks: Visits at 0, 6, 12 and 18 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/57 • Treatment period of 18 weeks: Visits at 0, 6, 12 and 18 weeks
|
1.9%
1/54 • Number of events 4 • Treatment period of 18 weeks: Visits at 0, 6, 12 and 18 weeks
|
3.8%
1/26 • Number of events 1 • Treatment period of 18 weeks: Visits at 0, 6, 12 and 18 weeks
|
0.00%
0/28 • Treatment period of 18 weeks: Visits at 0, 6, 12 and 18 weeks
|
|
Infections and infestations
Flu-like syndrome
|
0.00%
0/57 • Treatment period of 18 weeks: Visits at 0, 6, 12 and 18 weeks
|
3.7%
2/54 • Number of events 2 • Treatment period of 18 weeks: Visits at 0, 6, 12 and 18 weeks
|
0.00%
0/26 • Treatment period of 18 weeks: Visits at 0, 6, 12 and 18 weeks
|
3.6%
1/28 • Number of events 1 • Treatment period of 18 weeks: Visits at 0, 6, 12 and 18 weeks
|
|
Gastrointestinal disorders
Gastritis (including bile reflux gastritis)
|
3.5%
2/57 • Number of events 2 • Treatment period of 18 weeks: Visits at 0, 6, 12 and 18 weeks
|
0.00%
0/54 • Treatment period of 18 weeks: Visits at 0, 6, 12 and 18 weeks
|
0.00%
0/26 • Treatment period of 18 weeks: Visits at 0, 6, 12 and 18 weeks
|
0.00%
0/28 • Treatment period of 18 weeks: Visits at 0, 6, 12 and 18 weeks
|
|
Infections and infestations
Cough / upper respiratory tract infection
|
3.5%
2/57 • Number of events 2 • Treatment period of 18 weeks: Visits at 0, 6, 12 and 18 weeks
|
0.00%
0/54 • Treatment period of 18 weeks: Visits at 0, 6, 12 and 18 weeks
|
0.00%
0/26 • Treatment period of 18 weeks: Visits at 0, 6, 12 and 18 weeks
|
0.00%
0/28 • Treatment period of 18 weeks: Visits at 0, 6, 12 and 18 weeks
|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
0.00%
0/57 • Treatment period of 18 weeks: Visits at 0, 6, 12 and 18 weeks
|
0.00%
0/54 • Treatment period of 18 weeks: Visits at 0, 6, 12 and 18 weeks
|
3.8%
1/26 • Number of events 1 • Treatment period of 18 weeks: Visits at 0, 6, 12 and 18 weeks
|
0.00%
0/28 • Treatment period of 18 weeks: Visits at 0, 6, 12 and 18 weeks
|
Additional Information
Dr Annette Pflugfelder
Center for Dermatooncology, Department of Dermatology, University Hospital Tübingen, Tübingen, Germany
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Agreement on publication prior to disclosure
- Publication restrictions are in place
Restriction type: OTHER