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CompletedNCT00786994Updated Sep 14, 2015Results posted

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

A Phase 2 interventional study of Oleogel-S10 100 mg/g and Placebo (petroleum jelly) in Actinic Keratoses, sponsored by Birken AG. Completed at 6 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-09-14.

Sponsored by Birken AG · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
165
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

In this study the impact of Oleogel-S-10 versus placebo on actinic keratoses over a treatment period of 3 months will be tested. Additionally, once and twice daily applications are tested.

Read the detailed description

Oleogel-S-10 has shown efficacy and was well tolerated in two previous clinical trials. In the second open label phase II trial the efficacy of Oleogel-S-10 alone was similar compared to a more invasive treatment with cryotherapy. Response rates of 85% with a clear-ance of more than 75 % of the lesions of the patients treated with Oleogel-S-10 over three months were reported. These encouraging results led to the present randomized, multicenter, double blind phase II trial. The efficacy of the treatment shall be tested in a double blind placebo controlled (petroleum jelly) fashion in order to obtain more reliable results for the planning of a phase III study.

02

Conditions studied

  • Actinic Keratoses

Keywords

  • Actinic Keratoses
03

In context

Keratosis, Actinic

364 studies on the registry are indexed under Keratosis, Actinic; 31 are open to participants now.

This study's enrollment of 165 is above the median of 60 across 315 interventional studies indexed under Keratosis, Actinic.

Browse Keratosis, Actinic studies →

Lead sponsor

Birken AG is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • At least two mild to moderate actinic keratoses located at the facial skin or the head (except lips)

  • Actinic keratoses with a diameter of 0,5 - 2 cm,

    • that are definitely distinguished from other lesions and display a minimum distance of 0,5 cm to neighbored lesions
    • that are evaluated as histopathological grade 1 to 3
  • histologically proven AK within three months before study entry
  • prepared and able to give written informed consent
  • ≥ 18 years of age

  • In case of females: postmenopause defined as

    • natural menopause with menses > 1 year ago
    • serum FSH (> 20 IU/l) and E2 levels in the postmenopausal range or
    • patients who had bilateral oophorectomy

  • prepared and comply with all study requirements, including the following:

    • application of Oleogel-S10 on the treatment area once or twice a day
    • 4 clinic visits during the pre-study, treatment, post-treatment, and follow-up period
    • pre- and post-treatment biopsy for histological confirmation (of clearance) of AK-diagnosis
  • Representative histologic slide and tissue block were shipped

Exclusion criteria

Exclusion Criteria:

  • Active immunosuppressive therapy
  • data of clinically significant, unstable, cardiovascular or hematologic, hepatic, neurologic, renal, endocrine, collagen-vascular, or gastrointestinal abnormalities or diseases Note: Patients with clinically stable medical conditions including, but not limited to, controlled hypertension, diabetes mellitus type II, hypercholesterolemia, or osteoarthritis will be allowed to enter the study
  • known allergies to any excipient in the study drug
  • any dermatological disease and/or condition in the treatment or surrounding area (3 cm distances from treatment area) that may be exacerbated by treatment with Oleogel-S-10 or cause difficulty with examination
  • active chemical dependency or alcoholism, as assessed by the investigator
  • pregnant and lactating women
  • currently participating in another clinical study or have completed another clinical study with an investigational drug within the past 30 days
  • received topical treatment at the treatment area with diclofenac gel, imiquimod or 5-FU within a time period of 1 month
  • Concomitant existence of non-treated (non-excised) basal cell carcinoma, squamous cell carcinoma or malignant melanoma
  • Invasive tumors within the treatment area, e.g.: merkel cell carcinoma, squamous cell carcinoma, basal cell carcinoma, the latter is accepted if completely surgically removed Note: A biopsy of any lesion within the treatment or surrounding area suggestive of malignancy should be performed at the pre-study screening visit. If invasive SCC or other malignant conditions are confirmed within the treatment area, the patient will not be included in the study.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
165 participants (actual)

Study arms

  • Experimental
    1

    Oleogel-S10 100 mg/g ointment for three months once a day (54 patients)

    Drug: Oleogel-S10 100 mg/g

  • Experimental
    2

    Oleogel-S10 100 mg/g ointment for three months twice a day (54 patients)

    Drug: Oleogel-S10 100 mg/g

  • Placebo comparator
    3

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

    Drug: Placebo (petroleum jelly)

  • Placebo comparator
    4

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

    Drug: Placebo (petroleum jelly)

Interventions

  • DrugOleogel-S10 100 mg/g

    topical use once or twice daily

  • DrugPlacebo (petroleum jelly)

    topical use once or twice daily

    Also known as: Vaseline

06

What researchers measure

Primary outcomes

  1. Objective Response of the Marker Actinic Keratosis, Defined as Histologically Complete or Partial Clearance.

    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

07

Results

Posted Aug 14, 2015

Participant flow

165 patients were recruited.

Participant flow — Overall Study
MilestoneA - Oleogel-S10 Once DailyB - Oleogel-S10 Twice DailyC - Placebo Once DailyD - Placebo Twice Daily
Started57542628
Itt53512528
Completed47392422
Not completed101526

Outcome measures

PrimaryObjective Response of the Marker Actinic Keratosis, Defined as Histologically Complete or Partial Clearance.

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
Reported as:
Number · participants
Objective Response of the Marker Actinic Keratosis, Defined as Histologically Complete or Partial Clearance.
participantsA - Oleogel-S10 Once DailyB - Oleogel-S10 Twice DailyC/D - Placebo Once or Twice Daily
Success: Downgrading or clearance221719
Failure: No downgrading or clearance252227
Statistical analysis
  • A - Oleogel-S10 Once Daily vs C/D - Placebo Once or Twice Daily · Mantel Haenszel · p = 0.60
  • B - Oleogel-S10 Twice Daily vs C/D - Placebo Once or Twice Daily · Mantel Haenszel · p = 0.83

Adverse events

Collected over Treatment period of 18 weeks: Visits at 0, 6, 12 and 18 weeks. Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
A - Oleogel-S10 Once Daily—2/57 (3.5%)3/57 (5.3%)
B - Oleogel-S10 Twice Daily—3/54 (5.6%)7/54 (13%)
C - Placebo Once Daily—0/26 (0%)3/26 (11.5%)
D - Placebo Twice Daily—0/28 (0%)3/28 (10.7%)
Most frequent serious events
Most frequent serious events
EventA - Oleogel-S10 Once DailyB - Oleogel-S10 Twice DailyC - Placebo Once DailyD - Placebo Twice Daily
CholangiocarcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/571/540/260/28
Prolaps of intervertebral discMusculoskeletal and connective tissue disorders0/571/540/260/28
Basal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/571/540/260/28
Fracture of ribInjury, poisoning and procedural complications1/570/540/260/28
Respiratory infectionInfections and infestations1/570/540/260/28
Most frequent other events
Most frequent other events
EventA - Oleogel-S10 Once DailyB - Oleogel-S10 Twice DailyC - Placebo Once DailyD - Placebo Twice Daily
Basal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/571/540/262/28
RashSkin and subcutaneous tissue disorders0/573/541/260/28
PruritusSkin and subcutaneous tissue disorders0/571/541/260/28
Allergic reaction/hypersensitivity (including drug fever)Immune system disorders0/570/541/260/28
Flu-like syndromeInfections and infestations0/572/540/261/28
Gastritis (including bile reflux gastritis)Gastrointestinal disorders2/570/540/260/28
Cough / upper respiratory tract infectionInfections and infestations2/570/540/260/28

Baseline characteristics

ITT

Age, Continuous
Age, Continuous(years)A - Oleogel-S10 Once DailyB - Oleogel-S10 Twice DailyC - Placebo Once DailyD - Placebo Twice DailyTotal
Median72 (61 to 88)74 (56 to 85)69 (57 to 81)72 (51 to 83)72 (51 to 88)
Sex: Female, Male
Sex: Female, Male(Participants)A - Oleogel-S10 Once DailyB - Oleogel-S10 Twice DailyC - Placebo Once DailyD - Placebo Twice DailyTotal
Female41422025128
Male1295329
Actinic keratosis baseline severity index
Actinic keratosis baseline severity index(participants)A - Oleogel-S10 Once DailyB - Oleogel-S10 Twice DailyC - Placebo Once DailyD - Placebo Twice DailyTotal
Mild221891362
Moderate3133161595
Histopathological grading
Histopathological grading(participants)A - Oleogel-S10 Once DailyB - Oleogel-S10 Twice DailyC - Placebo Once DailyD - Placebo Twice DailyTotal
Grade I942217
Grade II111041237
Grade III32361913100
not done11013
08

Study locations

6 sites
  • Charité University Hospital
    Berlin, Germany
  • University Dermatology Hospital
    Freiburg, Germany
  • University Dermatology Hospital
    Tübingen, Germany
  • Dermatology practice
    Wuppertal, Germany
  • National University, "Andreas Syggros" Skin & Venereal Diseases Hospital
    Athens, Greece
  • University Dermatology Hospital
    Heraklion, Greece
09

References and documents

Publications

  • Pflugfelder A, Andonov E, Weide B, Dirschka T, Schempp C, Stockfleth E, Stratigos A, Kruger-Krasagakis S, Bauer J, Garbe C, Eigentler TK. Lack of activity of betulin-based Oleogel-S10 in the treatment of actinic keratoses: a randomized, multicentre, placebo-controlled double-blind phase II trial. Br J Dermatol. 2015 Apr;172(4):926-32. doi: 10.1111/bjd.13342. Epub 2015 Feb 25. PubMed 25124939 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00786994
Lead sponsor
Birken AG
Collaborators
University Hospital Tuebingen
Responsible party
Sponsor
First posted
Nov 6, 2008
Start date
Oct 2008
Primary completion
Nov 2010
Completion
Nov 2010
Results posted
Aug 14, 2015
Last update
Sep 14, 2015

Study contacts

Claus Garbe, Prof. Dr.
principal investigator · Universitätshautklinik Tübingen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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