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Efficacy and Safety Study to Compare Two Minoxidil Formulations on Women With Androgenetic Alopecia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00958750
Recruitment Status : Completed
First Posted : August 13, 2009
Last Update Posted : November 18, 2011
Information provided by:
Charite University, Berlin, Germany

Brief Summary:
The purpose of this study is to determine in women the risk/benefit profile and non-inferiority of a topical 5% Minoxidil foam formulation applied once daily for the treatment of androgenetic alopecia in comparison to 2% MTS used twice daily, using objective and subjective efficacy measures and safety assessments for a study period of 24 weeks.

Condition or disease Intervention/treatment Phase
Androgenetic Alopecia Female Pattern Hair Loss Drug: minoxidil Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 113 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2008
Actual Primary Completion Date : February 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Minoxidil

Arm Intervention/treatment
Active Comparator: 5% MTF
5% minoxidil topical foam used once daily
Drug: minoxidil
the investigators compared two different formulations and concentrations of minoxidil in this study

Active Comparator: 2% MTS
2% minoxidil topical solution twice daily use
Drug: minoxidil
the investigators compared two different formulations and concentrations of minoxidil in this study

Primary Outcome Measures :
  1. Change of target area non-vellus hair count (TAHC) [n/cm²] after 24 weeks [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Assessing the investigational products safety by means of clinical examination (local intolerance, facial hypertrichosis, AE, SAE) and blood Minoxidil level (baseline + week 24) [ Time Frame: 24 weeks ]
  2. Change of cumulative hair width in non-vellus hair (TAHW) after 24 weeks [ Time Frame: 24 weeks ]
  3. Global expert panel rating of change in scalp coverage via assessment of global photographs [ Time Frame: 24 weeks ]
  4. Volunteer questionnaire rating for administration and contentment of the study product [ Time Frame: 24 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 (See Appendix 1)
  • Hair density equal or less than 220 hairs /cm2 measured with TrichoScan
  • Subjects who give their consent to the study after thoroughly clarification 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
  • 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.

Exclusion Criteria:

  • 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, Isotretinoin, 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
  • Women with childbearing potential and 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
  • Individuals who are institutionalized by court or regulatory order

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00958750

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Charité-Universitaetsmedizin; Clinical Research Center for Hair and Skin Science
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany

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Responsible Party: Ulrike Blume-Peytavi, Clinical Research Center for Hair and Skin Science, Charité-Universitaetsmedizin Berlin Identifier: NCT00958750    
Other Study ID Numbers: CRC-AGA01
EudraCT: 2008-001770-33
First Posted: August 13, 2009    Key Record Dates
Last Update Posted: November 18, 2011
Last Verified: August 2009
Keywords provided by Charite University, Berlin, Germany:
Androgenetic alopecia
female pattern hair loss
Additional relevant MeSH terms:
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Alopecia Areata
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Antihypertensive Agents
Vasodilator Agents