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

NCT00786994 | Completed Phase 2 Results

• 1 other identifier: BAK-08
• Study Type: interventional
• Target: 165
• Locations: 2 countries
• Sites: 6

Brief 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.

Conditions

Actinic Keratoses

Keywords

Actinic Keratoses

Outcome Measures

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.

  18 weeks

Study Arms (4)

1

EXPERIMENTAL

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

Drug: Oleogel-S10 100 mg/g

2

EXPERIMENTAL

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

Drug: Oleogel-S10 100 mg/g

3

PLACEBO COMPARATOR

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

Drug: Placebo (petroleum jelly)

4

PLACEBO COMPARATOR

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

Drug: Placebo (petroleum jelly)

Interventions

Oleogel-S10 100 mg/g DRUG

topical use once or twice daily

1; 2

Placebo (petroleum jelly) DRUG

topical use once or twice daily

Also known as: Vaseline

3; 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Birken AG: lead
• University Hospital Tuebingen: collaborator

Study Sites (6)

Charité University Hospital

Berlin, Germany

Location

University Dermatology Hospital

Freiburg im Breisgau, Germany

Location

University Dermatology Hospital

Tübingen, Germany

Location

Dermatology practice

Wuppertal, Germany

Location

National University, "Andreas Syggros" Skin & Venereal Diseases Hospital

Athens, Greece

Location

University Dermatology Hospital

Heraklion, Greece

Location

Related Publications (1)

• 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.

  PMID: 25124939 RESULT

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Petrolatum

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Dr Annette Pflugfelder
• Organization: Center for Dermatooncology, Department of Dermatology, University Hospital Tübingen, Tübingen, Germany

annette.pflugfelder@med.uni-tuebingen.de

Study Officials

• Claus Garbe, Prof. Dr.

  Universitätshautklinik Tübingen

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2008
• First Posted: November 6, 2008
• Study Start: October 1, 2008
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: September 14, 2015
• Results First Posted: August 14, 2015

Record last verified: 2015-08

Locations

DE (4); GR (2)