Assessment of the efficacy of a new formulation of minoxidil (DC120) on hair growth, in a minizone model in androgenetic alopecia in me
- Conditions
- androgenetic alopeciaTherapeutic area: Body processes [G] - Genetic Phenomena [G05]
- Registration Number
- EUCTR2014-005573-36-DE
- Lead Sponsor
- Pierre Fabre Dermatologie represented by the Institut de Recherche Pierre Fabre (IRPF)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- Not specified
- Male aged from 18 to 65 years old
- Androgenetic alopecia on fronto-temporal areas (Norwood/Hamilton grade 3/3a, 3V to 4/4a)
- Phototype I to IV according to Fitzpatrick’s classification.
Ethical /legal considerations:
- Having signed the written informed consent (V0)
- Accepting to have 2 shaved and tattooed minizones on the scalp;
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 220
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
- Other known causes of alopecia (alopecia areata, hair loss related to endocrinopathies, telogen effluvium …);
- Any scalp abnormality, inflammation or disease processes in the skin including excoriation, psoriasis and sunburn; or any underlying conditions on the investigational areas that may interfere with the alopecia evaluation or favour product absorption;
- Shaved scalp
- History of surgery on the investigational scalp areas (e.g. hair transplant)
- Known hypersensitivity to minoxidil or any of the excipients;
- Minoxidil: within the last 3 months prior to V0 and during the study duration,
- Hair loss treatments within the last 3 months prior to V0 and during the study duration,
- Known cardiovascular disease, cardiopathy or cardiac arrhythmia
- Tachycardia;
- Treated or untreated hypertension;
- History of hypotension;
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate the non-inferiority of DC120 on hair growth, versus a reference product (ALOSTIL®), in the treatment of androgenetic alopecia, over 16 weeks. ;Secondary Objective: To evaluate the safety of DC120 in comparison to the reference product and placebo:<br>- Adverse events recorded at each visit, <br>- Dermal tolerability of each target zone: erythema, desquamation, pruritus, burning, others<br>- Global physical examination<br>- Vital signs: heart rate, blood pressure<br>;Primary end point(s): Change from baseline of nonvellus target area hair count (TAHC) (number of hair > 30 µm/cm²) measured using the phototrichogram method (Trichoscan) between V2 (baseline) and V10.;Timepoint(s) of evaluation of this end point: V2 (baseline) and V10 (Trial day 112).
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Change from baseline in nonvellus TAHC between V2 (baseline) and V6.<br>- Change from baseline in vellus TAHC:<br>o between V2 (baseline) and V6<br>o between V2 (baseline) and V10<br>- Change from baseline in total TAHC: <br>o between V2 (baseline) and V6<br>o between V2 (baseline) and V10<br>- Change from baseline in cumulative hair thickness (mm/cm²) density :<br>o between V2 (baseline) and V6<br>o between V2 (baseline) and V10<br>;Timepoint(s) of evaluation of this end point: V2 (baseline) and V6 (trial day 56) and V10 (Trial day 112), respectively.