Effectiveness and Safety of Minoxidil Foam Versus Placebo Foam for Androgenetic Alopecia

Natalie GARCIA BARTELS

Status and phase

Completed

Phase 2

Conditions

Androgenetic Alopecia

Treatments

Drug: Minoxidil

Drug: vehicle of 5% Minoxidil topical foam

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01319370

CRC-AGA02

2010-018291-25 (EudraCT Number)

Details and patient eligibility

About

The current study aims to show efficacy of twice daily application of 5% Minoxidil Topical Foam (MTF) formulation compared to placebo in the temple region of male patients with androgenetic alopecia after 24 weeks as well as to gain long-term data on the efficacy and safety of 5% MTF in male subjects with AGA in temple and vertex region, over a period of 2 years. Objective and subjective efficacy measures will be compared to baseline. Moreover, all patients will get the equal treatment and measurements in the vertex region to enable comparison of the efficacy of 5% Minoxidil Topical Foam in the temples not only to baseline but also to vertex region. Additionally safety assessments will be performed throughout the whole study.

Enrollment

70 patients

Sex

Male

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male, age 18 to 70 year old, in general good health
Exhibits male AGA based on a discernable hair loss in temple and vertex region rating Hamilton-Norwood Scale III vertex to VI (See Appendix 1)
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, 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

Exclusion criteria

Known to be hypersensitive to minoxidil, hair dye (p-phenylenediamine), tattoo ink, fragrances, hair gel or any vehicle components
Current or 4 weeks dated back use of medical shampoos or solutions which include Ketoconazole or the like (e. g. Terzolin®) in the target region interfering with the CTM 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 CTM (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 CTM or examination method (beta blocker, cimetidine, diazoxide, isotretionin, corticosteroids, vitamin A intake above 10000 IU per day)
Current or 12 months dated back use of Finasteride (Propecia®, FinaHair®, etc.), Dutasteride 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 or non-breathable wigs and 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 CTM 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