androgenetic alopecia
Conditions
Interventions
Product Code: DC120
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: MINOXIDIL
CAS Number: 38304-91-5
Concentration unit: % percent
Concentration type: equal
Concentration number: 5-
Phar
Sponsors
Pierre Fabre Dermatologie represented by the Institut de Recherche Pierre Fabre (IRPF)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: - Adverse events recorded at each visit, - Dermal tolerability of each target zone: erythema, desquamation, pruritus, burning, others - Global physical examination - Vital signs: heart rate, blood pressure ;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
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Change from baseline in nonvellus TAHC between V2 (baseline) and V6. - Change from baseline in vellus TAHC: o between V2 (baseline) and V6 o between V2 (baseline) and V10 - Change from baseline in total TAHC: o between V2 (baseline) and V6 o between V2 (baseline) and V10 - Change from baseline in cumulative hair thickness (mm/cm²) density : o between V2 (baseline) and V6 o between V2 (baseline) and V10 ;Timepoint(s) of evaluation of this end point: V2 (baseline) and V6 (trial day 56) and V10 (Trial day 112), respectively. | — |
Countries
Germany
Contacts
Public ContactFrançoise TONNER
Pierre Fabre Dermatologie represented by the Institut de Recherche Pierre Fabre (IRPF)
Outcome results
None listed