Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis (sun spots) on Balding Scalp including 12-month follow-up
- Conditions
- Actinic KeratosisMedDRA version: 18.1Level: PTClassification code 10000614Term: Actinic keratosisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2015-002452-27-DE
- Lead Sponsor
- EO Pharma A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 306
Signed and dated informed consent has been obtained.
Subjects with 5 to 20 clinically typical, visible and discrete AKs within a treatment area of
sun-damaged skin on the full balding scalp (the balding part of the scalp should be greater
than 25 cm2 and up to approximately 250 cm2).
Subjects at least 18 years of age.
Female subjects of childbearing potential must be confirmed not pregnant by a negative
urine pregnancy test prior to trial treatment.
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 153
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 153
-Location of the treatment area (full balding scalp)
•within 5 cm of an incompletely healed wound
•within 5 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC)
-Treatment with ingenol mebutate gel in the treatment area within the last 12 months
-Lesions in the treatment area that have: atypical clinical appearance (e.g. hypertrophic, hyperkeratotic or cutaneous horns) and/or recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To confirm the efficacy of LEO 43204 gel (0.037% for scalp) in AK when applied topically once daily for three consecutive days as field treatment;Secondary Objective: To evaluate the safety of LEO 43204 gel (0.037% for scalp) in AK when applied topically once daily for three consecutive days as field treatment<br><br>To evaluate the long term efficacy of LEO 43204 gel (0.037% for scalp) in AK in an extended 12-month follow-up period after initial complete clearance at Week 8;Primary end point(s): Complete clearance at Week 8, defined as no clinically visible AKs in the treatment area;Timepoint(s) of evaluation of this end point: Week 8
- Secondary Outcome Measures
Name Time Method Secondary end point(s): -Partial clearance at Week 8, defined as at least 75% reduction in the number of clinically<br>visible AKs in the treatment area<br>-Partial clearance at Week 4, defined as at least 75% reduction in the number of clinically<br>visible AKs in the treatment area<br>-Percent reduction in AK count in the treatment area at Week 8 compared to baseline<br>-safety and tolerability of LEO 43204 gel;Timepoint(s) of evaluation of this end point: -Week 8<br>-Week 8<br>-Week 4