Women’s 5% Minoxidil Foam Trial

  • 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. VEHICLE IN FEMALES FOR THE TREATMENT OF FEMALE PATTERN HAIR LOSS (ANDROGENETIC ALOPECIA)

  • IRAS ID

    60680

  • Contact name

    John Berth-Jones

  • Sponsor organisation

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

  • Eudract number

    2010-019881-96

  • ISRCTN Number

    N/A

  • Research summary

    Female pattern hair loss (androgenetic alopecia) is a hereditary condition mainly occurring in post-menopausal women but can occur in women of all ages. Unlike men, there is a thinning of the hair over the whole scalp but rarely leads to balding, with the resulting hair loss affecting the women??s self-image.Minoxidil, when applied to the skin, has been shown to reverse miniaturization of the hair follicle and lengthen the follicle growth phase. Minoxidil Topical Solution (MTS) has been approved for the treatment of pattern hair loss in males and females and has a proven post marketing safety record. However, this topical solution can cause localized irritation with patients finding the product aesthetically displeasing. Therefore, a new foam formulation, containing 5% minoxidil with a hydro-alcohol based vehicle, has been developed to potentially address these issues.This formulation will differ from the currently marketed product in form (foam rather than a solution), concentration (5% rather than 2%), and dosing schedule (once a day rather than twice a day) allowing for potentially increased usage compliance due to a more aesthetically pleasing formula and once a day dose to address the inconvenience of twice daily use.The study will be conducted at multiple sites located across the UK and globally, recruiting female patients aged 18 and above who are suffering from female pattern hair loss. Patients will be randomized in a 1:1 ratio to use either 5% MTF or an inactive foam once a day, for 24 weeks. During the trial following enrollment at Baseline, patients will return to the study site at Weeks 1, 6, 12, 18 and 24, for safety, adverse event monitoring, and compliance assessments. At the Week 12 and 24 visits, assessments will also be conducted to see if it is successful.

  • REC name

    North West - Liverpool Central Research Ethics Committee

  • REC reference

    10/H1005/61

  • Date of REC Opinion

    30 Sep 2010

  • REC opinion

    Further Information Favourable Opinion