INVESTIGATOR-INITIATED SINGLE BLIND, TWO-ARMED, RANDOMIZED PHASE 3 CLINICAL TRIAL TO COMPARE EFFICACY OF 5% MINOXIDIL TOPICAL FOAM (5% MTF) ONCE DAILY VERSUS 2% MINOXIDIL TOPICAL SOLUTION (2% MTS) TWICE DAILY IN APPLICATION ON FEMALES WITH SLIGHTLY TO MODERATE ANDROGENETIC ALOPECIA CONCERNING HAIR VOLUME Investigator-initiierte einfach verblindete, zweiarmige, randomisierte klinische Phase 3 Studie zum Nachweis der Wirksamkeit auf das Haarvolumen von 5%igen Minoxidil 1x tgl. versus 2%igem Minoxidil 2x tgl. bei Frauen mit leichter bis mäßiger androgenetischer Alopezie
- Conditions
- Women above 18 years old with slightly to moderate androgenetic alopecia (AGA), otherwise in general good health.The subjects have to show a female pattern type of AGA, Savin scale D3-D6 and a hair density minor 220/cm2.
- Registration Number
- EUCTR2008-001770-33-DE
- Lead Sponsor
- Charité-Universitätsmedizin Berlin, Klinik für Dermatologie, Venerologie und Allergologie, CRC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 114
Female, age 18 or older, in general good health.
Exhibits AGA based on a discernable decrease in hair density on the top of the scalp, relative to the sides and back of the scalp, with scalp hair density in involved area D3 to D6 on the Savin Density Scale.
Hair density equal or less than 220 hairs /cm2 measured with TrichoScan.
Exhibits of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative), has been informed of all pertinent aspects of the trial.
Women of childbearing potential, who practice an effective method of contraception for at least five consecutive weeks prior to the study entry and during the study with one of the following methods:
-Double contraceptive method among hormonal contraception (e. g. contraceptive pill, intra uterine device, vaginal ring, injectable or implantable contraception), spermicide, condom and diaphragm. Oral/systemic contraception must have been the same during the past 6 months and will not be changed during the study
-Sexual abstinence
-Partner with a vasectomy (dated back more than 6 months)
OR
Women of non-childbearing potential, i. e. postmenopausal (absence of menstrual bleeding for 2 years), or had hysterectomy, bilateral tubal ligation or bilateral ovariectomy.
Women of childbearing potential must show a negative urine pregnancy test at Screening.
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, laboratory test and other trial procedures.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Known to be hypersensitive to Minoxidil, hair dye (P-Phenylendiamin), Tattoo ink, propylene glycol, fragrances, hair gel or any vehicle components.
Current or 4 weeks dated back use of local treatment (drug or cosmetically) in the target region interfering with the study product or examination method (corticosteroids, Aminexil, Minoxidil, medical shampoos, topical estrogen, Ketoconazol).
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).
Within past 6 month receiving of chemotherapy/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 last 4 weeks.
Woman with childbearing potential with insufficient contraception.
Female who is pregnant, planning a pregnancy (during the course of the study) or nursing a child.
Presence of hair transplants, hair weaves or non-breathable wigs.
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.
Active hair loss or history within the past 3 months including diffuse telogen effluvium, alopecia areata, scarring alopecia and androgen hair loss /hyper-androgenemia).
Other severe, acute or chronic medical condition that may lead to hair loss or interfere with the interpretation of trial results.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Primary objective is the change of target area non-vellus hair count (TAHC) [n/cm²] after 24 weeks;Secondary Objective: Change of cumulative hair width in non-vellus hair (TAHW) after 24 weeks<br>Global expert panel rating of change in scalp coverage via assessment of global photographs<br>Subject rating of change in scalp coverage via global photographs<br>Assessing the investigational products safety by means of clinical examination (local intolerance, facial hypertrichosis, AE, SAE) and blood Minoxidil level (baseline + week 24)<br>Volunteer questionnaire for administration and contentment of the study product<br>;Primary end point(s): The objective of this study is to demonstrate the non-inferiority of 5% Foam once daily to 2% Solution twice daily.
- Secondary Outcome Measures
Name Time Method