Ingenol Mebutate Gel, 0.015% Repeat Use for Multiple Actinic Keratoses on Face and Scalp
- Conditions
- Actinic keratosis on the face and scalpMedDRA version: 14.1 Level: PT Classification code 10000614 Term: Actinic keratosis System Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2011-005018-13-GB
- Lead Sponsor
- EO Pharma A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 450
1. Following verbal and written information about the trial, subject must provide informed consent documented by signing the Informed Consent Form (ICF) prior to any trial-related procedures
2. Subjects with 4 to 8 clinically typical, visible and discrete AKs within a contiguous 25 cm2 treatment area on the face or scalp
3. Subject at least 18 years of age
4. Female subjects must be of either:
a. Non-childbearing potential, i.e. post-menopausal or have a confirmed clinical history of sterility (e.g. the subject is without a uterus) or,
b. Childbearing potential, provided there is a confirmed negative urine pregnancy test prior to study treatment, to rule out pregnancy.
5. Female subjects of childbearing potential must be willing to consent to using highly effective methods of contraception (Pearl index < 1%) at study entry until completion of the Second Treatment Cycle (i.e. 8 weeks after randomisation) or until Week 44 for those subjects not randomised. These methods of contraception are defined as:
• abstinence (when this is in line with the preferred and usual lifestyle of the subject)
• vasectomised partner (partner should be the sole partner for the subject)
• an intrauterine device
• double barrier method defined as two distinct methods (either two actual barrier methods or one actual barrier method and one hormonal method)
• hormonal contraceptive (oral hormonal birth control, estrogenic vaginal ring, percutaneous contraceptive patches, implants and injectables) for at least one menstrual cycle prior to enrolment (Day 1)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 104
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 350
1. Location of the selected treatment area:
• on any location other than the face or scalp
• on the periorbital skin
•within 5 cm of an incompletely healed wound
• within 10 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC)
2. Prior treatment with ingenol mebutate gel on face or scalp (previous treatment on trunk and extremities acceptable).
3. Selected treatment area lesions that have atypical clinical appearance.
4. History or evidence of skin conditions other than the trial indication that would interfere with evaluation of the trial medication in the selected treatment area (e.g., eczema, psoriasis).
5. Anticipated need for hospitalization or out-patient surgery prior to Day 15 in the first treatment cycle.
6. Known sensitivity or allergy to any of the ingredients in ingenol mebutate gel.
7. Presence of sunburn within the selected treatment area
8. Current enrolment or participation in a clinical trial within 30 days of entry into this study.
9. Subjects previously entered first treatment in the trial.
10. Female subjects who are breastfeeding.
11. Subjects who are institutionalised by court order or by the local authority
12. In the opinion of the investigator, the subject is unlikely to comply with the Clinical Study Protocol (e.g. alcoholism, drug dependency or psychotic state)
The rest of exclusion criteria apply to prohibited therapies/medicines and are listed in the protocol.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method