Assessment of the efficacy of a new formulation of minoxidil (DC120) on hair growth, in a minizone model in androgenetic alopecia in men

• Register: EUCTR
• Last refreshed on: 6 February 2017
• Main ID: EUCTR2014-005573-36-DE
• Date of registration: 10/04/2015
• Prospective Registration: Yes
• Primary sponsor: Pierre Fabre Dermatologie represented by the Institut de Recherche Pierre Fabre (IRPF)
• Public title: Assessment of the efficacy of a new formulation of minoxidil (DC120) on hair growth, in a minizone model in androgenetic alopecia in men
• Scientific title: Assessment of the efficacy of a new formulation of minoxidil (DC120) on hair growth, in a minizone model in androgenetic alopecia in men
• Date of first enrolment: 18/06/2015
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-005573-36
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: yes Other: no Number of treatment arms in the trial: 4
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Germany

Contacts

• Name: Françoise TONNER
• Affiliation: Pierre Fabre Dermatologie represented by the Institut de Recherche Pierre Fabre (IRPF)

• Name: Françoise TONNER
• Affiliation: Pierre Fabre Dermatologie represented by the Institut de Recherche Pierre Fabre (IRPF)

Key inclusion & exclusion 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:
- 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;



Age minimum:
Age maximum:
Gender:
Female: no
Male: yes

Health Condition(s) or Problem(s) studied

androgenetic alopecia

Therapeutic area: Body processes [G] - Genetic Phenomena [G05]

Intervention(s)

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-
Pharmaceutical form of the placebo: Cutaneous solution
Route of administration of the placebo: Cutaneous use

Trade Name: ALOSTIL
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: MINOXIDIL
CAS Number: 38304-91-5
Concentration unit: % percent
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Cutaneous solution
Route of administration of the placebo: Cutaneous use

Primary Outcome(s)

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

Timepoint(s) of evaluation of this end point: V2 (baseline) and V10 (Trial day 112).

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.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: V2 (baseline) and V6 (trial day 56) and V10 (Trial day 112), respectively.

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

Secondary ID(s)

DC0120LE202

Source(s) of Monetary Support

Pierre Fabre Dermatologie