Actinic KeratosesPhase 2NCT00786994
The Efficacy and Tolerability of Oleogel-S-10 in Patients With Actinic Keratoses
A Phase 2 study testing Oleogel-S10 100 mg/g in people with Actinic Keratoses, run by Birken AG at 6 sites in 2 countries.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Keratoses
- What is being tested?
- Oleogel-S10 100 mg/g
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 165 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Oct 2008to Nov 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 16Show fewer
- ≥ 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
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Germany4 sites
Charité University Hospital
Berlin
University Dermatology Hospital
Freiburg im Breisgau
University Dermatology Hospital
Tübingen
Dermatology practice
Wuppertal
Greece2 sites
National University, "Andreas Syggros" Skin & Venereal Diseases Hospital
Athens
University Dermatology Hospital
Heraklion
About this study
Official title: Randomized, Multicenter, Double Blind Study to Compare the Efficacy and Tolerability of Oleogel-S-10 for 3 Month Versus Placebo Only in Patients With Mild to Moderate Actinic Keratoses Located at the Face and Head Oleogel-S-10 in Actinic Keratoses Trial
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.
- Conditions
- Actinic Keratoses
- Being tested
- Oleogel-S10 100 mg/g, Placebo (petroleum jelly)
- Keywords
- Actinic Keratoses
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oleogel-S10 100 mg/gDrug
topical use once or twice daily
Placebo (petroleum jelly)Drug
Also called Vaseline
topical use once or twice daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Oleogel-S10 100 mg/g ointment for three months once a day (54 patients) Receives: Drug: Oleogel-S10 100 mg/g |
| 2 | Experimental | Oleogel-S10 100 mg/g ointment for three months twice a day (54 patients) Receives: Drug: Oleogel-S10 100 mg/g |
| 3 | Placebo comparator | Placebo (petroleum jelly) for three months once a day (27 patients) Receives: Drug: Placebo (petroleum jelly) |
| 4 | Placebo comparator | Placebo (petroleum jelly) for three months twice a day (27 patients) Receives: Drug: Placebo (petroleum jelly) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2008 (estimated)
- Study startOct 2008
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Actinic KeratosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Birken AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital Tuebingen
- Responsible party
- Sponsor
- Investigators
- Claus Garbe, Prof. Dr., Principal investigator, Universitätshautklinik Tübingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00786994
- Sponsor's protocol ID
- BAK-08
- Status last verified
- Aug 2015
- First submitted
- 5 Nov 2008
- Last updated
- 14 Sep 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Multicenter, Double Blind Study to Compare the Efficacy and Tolerability of Oleogel-S-10 for 3 Month Versus Placebo Only in Patients With Mild to Moderate Actinic Keratoses Located at the Face and Head Oleogel-S-10 in Actinic Keratoses Trial
- ClinicalTrials.gov ID
- NCT00786994
- Acronym / sponsor ID
- BAK-08
- Conditions
- Actinic Keratoses
- Keywords
- Actinic Keratoses
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Birken AGIndustry (pharma, biotech, devices)
- Collaborators
- University Hospital Tuebingen
- Study start
- Oct 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 6 Nov 2008 (estimated)
- Results
- Posted 14 Aug 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Oleogel-S10 100 mg/gOleogel-S10 100 mg/g ointment for three months once a day (54 patients) |
| 2 | Experimental | Drug: Oleogel-S10 100 mg/gOleogel-S10 100 mg/g ointment for three months twice a day (54 patients) |
| 3 | Placebo comparator | Drug: Placebo (petroleum jelly)Placebo (petroleum jelly) for three months once a day (27 patients) |
| 4 | Placebo comparator | Drug: Placebo (petroleum jelly)Placebo (petroleum jelly) for three months twice a day (27 patients) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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,
- histologically proven AK within three months before study entry
- prepared and able to give written informed consent
- ≥ 18 years of age
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oleogel-S10 100 mg/gtopical use once or twice daily | Drug | 1, 2 |
| Placebo (petroleum jelly)Also: Vaselinetopical use once or twice daily | Drug | 3, 4 |
Primary outcome
Objective Response of the Marker Actinic Keratosis, Defined as Histologically Complete or Partial Clearance.
Time frame: 18 weeks
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25124939Pflugfelder 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.
Related trials for Actinic Keratoses
RecruitingPhase 3
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Upper Extremities
Actinic Keratosis
RecruitingPhase 3
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Face and Scalp
Actinic Keratosis
Active, not recruitingPhase 3
A Pilot Clinical Trial Comparing Topical Fluorouracil to Fluorouracil Plus Calcipotriene Field Treatments in Patients With Multiple Actinic Keratoses
Multiple Actinic Keratoses
RecruitingPhase 3
Basal Cell Carcinoma Chemoprevention Trial
Basal Cell Carcinoma
Active, not recruitingPhase 4
Cryotherapy in Combination With Red Light PDT for Actinic Keratosis of Full Face
Actinic Keratoses
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claus Garbe, Prof. Dr. principal investigator
Universitätshautklinik Tübingen
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oleogel-S10 100 mg/g in people with Actinic Keratoses, run by Birken AG at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response of the Marker Actinic Keratosis, Defined as Histologically Complete or Partial Clearance. (time frame: 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00786994, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2015.