Study to compare the effectiveness on hair growth and safety of a 5% minoxidil foam versus placebo foam over 24 weeks, when twice dialy applied on the hair thinning sites in male patients with androgenetic alopecia. After the 24 weeks period all willing subjects can participate in the open-label phase of the study, getting 5% minoxidil foam for further 80 weeks.

• Conditions: Otherwise healthy men with androgenetic alopecia (Hamilton-Norwood Scale IIIvertex to VI) in the temple and vertex area.; MedDRA version: 13.1Level: PTClassification code 10068168Term: Androgenetic alopeciaSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2010-018291-25-DE
• Lead Sponsor: Charité-Universitätsmedizin Berlin, Klinik für Dermatologie, Venerologie und Allergologie, CRC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-24
• Last Update Posted: 12 May 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

- Male, age 18 to 70, in general good health.
- Exhibits male AGA based on a discernable hair loss in temple and vertex region rating Hamilton-Norwood Scale IIIvertex to VI
- Subjects who give their consent to the study after thorough explanation and who personally signed and dated the informed consent document indicating that the subject (or a legally acceptable representative), has been informed of all pertinent aspects of the trial.
- Willing to maintain the same hairstyle, hair length and hair color throughout the study.
- Subjects who are willing and able to comply with scheduled visits, treatment plan, mini-tattoo and other trial procedures.
- Accepting the Information form plus accepting and signing the Informed Consent form.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 62
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

Exclusion Criteria

- Known to be hypersensitive to minoxidil, hair dye (p-phenylendiamin), tattoo ink, fragrances, hair gel or any vehicle components
- Current or 4 weeks dated back use of medical shampoos or solutions which include Ketoconazol or the like (e. g. Terzolin®) in the target region interfering with the study product or examination method
- Current or 3 months dated back use of topical treatment in the target regions taken for more then 2 consecutive weeks interfering with the study product (topical corticosteroids, aminexil, minoxidil, estrogens)
- Current or 3 months dated back use of systemic treatment (drugs or dietary supplement) taken for more than 2 consecutive weeks interfering with the study product or examination method (beta blocker, Cimetidine, Diazoxid, Isotretionin, corticosteroids, vitamin A intake above 10000 IU per day)
- Current or 12 months dated back use of Finasteride (Propecia®, FinaHair®, etc.), Durasteride or a similar product
- Within past 12 months undergoing chemotherapy or receiving cytotoxic agents as well as radiation and/or laser/surgical therapy of the scalp
- Current or prior enrollment in any other investigational medication (drug) study within the 4 weeks prior to study initiation.
- Presence of hair transplants, hair weaves, non-breathable wigs or hair bonding
- Current or 2 months dated back severe diet or presenting a history of eating disorder
- Any dermatological disorders of the scalp in the target region with the possibility of interfering with the study product or examination method, such as fungal or bacterial infections, seborrheic dermatitis, psoriasis, eczema, folliculitis, scars or scalp atrophy
- Untreated persisting hypertension
- Active hair loss or history within the past 3 months including diffuse telogen effluvium, alopecia areata, scarring alopecia
- Other severe, acute or chronic medical condition that may lead to hair loss or interfere with the interpretation of trial results (e. g. untreated hypothyroidism)
- Individuals who are institutionalized by court or regulatory order

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified