Clinical Trial in Females With Female Pattern Hair Loss

2014-07-23 21:08:45 | BioPortfolio


This is a year-long clinical trial to evaluate the effectiveness and safety in women with Female Pattern Hair Loss (FPHL), comparing a new 5% minoxidil topical foam (MTF) formulation applied once a day versus the 2% minoxidil topical solution (MTS) applied twice a day.

This clinical trial will use a standard measurement called Target Area Hair Count (TAHC) to evaluate if there is a change in the number of hairs in the area being examined after using the product for 24 weeks (and also after using the product for 12 Weeks).

This trial will determine if the benefit of using either study product outweighs the risks.


This is a phase 3, two-arm, randomized, active-controlled, multi-center, 52-week, parallel design trial to evaluate the efficacy and safety in women with FPHL, comparing the new 5% MTF formulation versus the 2% MTS formulation.

This clinical trial is designed to compare the risk/benefit profile of the 5% MTF formulation applied once a day versus the 2% MTS applied twice a day (BID), using objective efficacy measures and safety assessments.

Study centers will screen a sufficient number of subjects so that a minimum of 300 female subjects with FPHL will be enrolled, to ensure 270 to complete. There will be at least 16 subjects enrolled per center at multiple centers located across the US and globally. Approximately 300 subjects will be randomized in a 1:1 ratio to use either 5% MTF or 2% MTS, for 52 weeks for efficacy and safety evaluations.

Subjects meeting the inclusion criteria will be randomized in the order of their enrollment at each site. The signing of the informed consent and assignment of a subject number to a subject shall constitute enrollment.

During the trial following enrollment at Baseline, subjects will return to the study site at regular intervals for safety assessments, adverse events monitoring, and compliance assessments. At the Week 12 and 24 visits TAHC will be recorded for primary and secondary outcome analysis.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment




5% Minoxidil, 2% Minoxidil


Burke Pharmaceutical Research
Hot Springs
United States




Johnson & Johnson Consumer & Personal Products Worldwide

Results (where available)

View Results


Published on BioPortfolio: 2014-07-23T21:08:45-0400

Clinical Trials [117 Associated Clinical Trials listed on BioPortfolio]

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

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 androgene...

Topical 5% Minoxidil and Potent Topical Corticosteroid Versus Intralesional Corticosteroid in the Treatment of Alopecia Areata

Alopecia areata (AA) presents with circumscribed patches of non-scarring hair loss. It inflects a significant psychological and social burden. Many treatment options are used for the treat...

Minoxidil Dose Response Study in Females Identified Through IVD Testing as Non-Responders to 5% Topical Minoxidil

5% topical minoxidil is the maximum dosage approved by the US FDA for the treatment of female pattern hair loss. While topical minoxidil exhibits a good safety profile, the efficacy in the...

The Use of 5mg Finasteride Versus 200mg Spironolactone and Topical 5% Minoxidil in Treating Postmenopausal Female Androgenetic Alopecia

The investigators propose to conduct a head-to-head, randomized clinical trial to compare the effectiveness of Minoxidil with Spironolactone and Finasteride in treating postmenopausal fema...

Platelet Rich Plasma Versus Minoxidil Foam for Treatment of Androgenic Alopecia in Women

The primary objective of this proposal is to conduct a study that assesses the safety, feasibility and efficacy of using PRP to treat this type of hair loss.

PubMed Articles [126 Associated PubMed Articles listed on BioPortfolio]

A randomized, double-blind controlled study of the efficacy and safety of topical solution of 0.25% finasteride admixed with 3% minoxidil versus 3% minoxidil solution in the treatment of male androgenetic alopecia.

The synergism of combined use between oral finasteride and topical minoxidil has been established in treating androgenetic alopecia among men. However, the concern regarding adverse effects of finaste...


Topical minoxidil is the only US FDA approved OTC drug for the treatment of androgenetic alopecia (AGA). Minoxidil is a pro-drug converted into its active form, minoxidil sulfate, by the sulfotransfer...

Controversies in the treatment of androgenetic alopecia: The history of finasteride.

Male androgenetic alopecia (AGA) affects up to 60% of men by the age of 50. Currently, there are only two approved drugs for the treatment of male AGA: topical minoxidil and oral finasteride. Topical ...

Lysyl Hydroxylase Inhibition by Minoxidil Blocks Collagen Deposition and Prevents Pulmonary Fibrosis via TGF-β₁/Smad3 Signaling Pathway.

BACKGROUND Idiopathic pulmonary fibrosis (IPF) is a deadly disease characterized by excessive collagen in the extracellular matrix (ECM) of the lungs. Collagen is the primary protein component of the ...

Over-the-Counter Hair Loss Treatments: Help or Hype?

Introduction: A limited number of treatments have been approved for androgenetic alopecia, however, myriad over-the-counter products for hair loss are available and readily purchased by consumers. Thi...

Medical and Biotech [MESH] Definitions

A potent direct-acting peripheral vasodilator (VASODILATOR AGENTS) that reduces peripheral resistance and produces a fall in BLOOD PRESSURE. (From Martindale, The Extra Pharmacopoeia, 30th ed, p371)

Heteromultimers of Kir6 channels (the pore portion) and sulfonylurea receptor (the regulatory portion) which affect function of the HEART; PANCREATIC BETA CELLS; and KIDNEY COLLECTING DUCTS. KATP channel blockers include GLIBENCLAMIDE and mitiglinide whereas openers include CROMAKALIM and minoxidil sulfate.

Absence of hair from areas where it is normally present.

A microscopically inflammatory, usually reversible, patchy hair loss occurring in sharply defined areas and usually involving the beard or scalp. (Dorland, 27th ed)

Precursor of an alkylating nitrogen mustard antineoplastic and immunosuppressive agent that must be activated in the LIVER to form the active aldophosphamide. It has been used in the treatment of LYMPHOMA and LEUKEMIA. Its side effect, ALOPECIA, has been used for defleecing sheep. Cyclophosphamide may also cause sterility, birth defects, mutations, and cancer.

More From BioPortfolio on "Clinical Trial in Females With Female Pattern Hair Loss"

Quick Search


Relevant Topics

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...

Women's Health
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...

Searches Linking to this Trial