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

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Brief Title

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

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

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.
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Change of target area non-vellus hair count (TAHC) [n/cm²] after 24 weeks

Secondary Outcome

 Assessing the investigational products safety by means of clinical examination (local intolerance, facial hypertrichosis, AE, SAE) and blood Minoxidil level (baseline + week 24)

Condition

Androgenetic Alopecia

Intervention

minoxidil

Study Arms / Comparison Groups

 5% MTF
Description:  5% minoxidil topical foam used once daily

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

113

Start Date

June 2008

Completion Date

June 2009

Primary Completion Date

February 2009

Eligibility Criteria

        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
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

Germany

Location Countries

Germany

Administrative Informations


NCT ID

NCT00958750

Organization ID

CRC-AGA01

Secondary IDs

EudraCT: 2008-001770-33


Study Sponsor

Charite University, Berlin, Germany


Study Sponsor

, , 


Verification Date

August 2009