5% MTF FOR THE TREATMENT OF FEMALE PATTERN HAIR LOSS (Apr 2010)

• Research type

  Research Study

• Full title

  A PHASE 3 MULTI-CENTER PARALLEL DESIGN CLINICAL TRIAL TO COMPARE THE EFFICACY AND SAFETY OF 5% MINOXIDIL FOAM VS. 2% MINOXIDIL SOLUTION IN FEMALES FOR THE TREATMENT OF FEMALE PATTERN HAIR LOSS (ANDROGENETIC ALOPECIA).

• IRAS ID

  52857

• Contact name

  Andrew Guy Messenger

• Sponsor organisation

  Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.

• Eudract number

  2009-018109-29

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Female Pattern Hair Loss (FPHL) or androgenetic alopecia is a hereditary condition. Some degree of hair loss is estimated to occur in approximately 50% of men and women over the age of 50 years. Most individuals are concerned about hair loss and how it affects their self-image. This study is being conducted for Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc. to see how safe and effective an investigational new product called 5% Minoxidil topical foam (MTF) formulation is for the treatment of FPHL.In most countries throughout the world, 2% Minoxidil topical solution (MTS) is the approved dose for the treatment of FPHL. MTS has been approved for use in women with FPHL for over 15 years, with a long-standing proven safety and efficacy profile. The formulation (5% MTF) being used in this study will differ from the currently marketed product in form, concentration, and dosing schedule. This study is being done to determine the risk/benefit profile of a 5% MTF formulation applied once daily for the treatment of FPHL in comparison to 2% MTS used twice daily. Approximately 300 women, aged 18 or older with FPHL will be enrolled in this study. There will be at least 16 subjects enrolled at multiple centres located world-wide. Subjects will be randomized to use either 5% minoxidil foam once a day or 2% minoxidil topical solution twice a day, for 52 weeks which will include approximately 11 study visits to the study centre.

• REC name

  Wales REC 3

• REC reference

  10/MRE09/14

• Date of REC Opinion

  6 Sep 2010

• REC opinion

  Further Information Favourable Opinion