Clinical Trial in Females for Female Pattern Hair Loss

Learn more about:
Related Clinical Trial
A Study Evaluating the Hair Regrowth Efficacy and Safety of ALRV5XR in Male Subjects With Hair Loss A Study Evaluating the Hair Regrowth Efficacy and Safety of ALRV5XR in Female Subjects With Hair Loss Anti-Androgen Treatment for COVID-19 A Study to Evaluate the Superiority, Efficacy and Tolerability of Combination Pantovigar With 2% Minoxidil vs 2% Minoxidil in Women With Female Pattern Hair Loss The Effect of Platelet Rich Plasma on Non-scarring Alopecia Optimizing Parameters for Long-pulsed Nd:YAG Laser for Reducing Hair Shaft Diameter HairDx Analytical Validation Study The Efficacy and Safety of Topical Valproic Acid in Preventing Hair Loss A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0002899) A Study to Evaluate and Compare Injections of Autologous Dermal Cells Into the Balding Scalp of Subjects With Hair Loss A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0002013) A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0002012) A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss Minoxidil Dose Response Study in Females Identified Through IVD Testing as Non-Responders to 5% Topical Minoxidil A Study to Evaluate and Compare Injections of Autologous Mixed Population of Dermal Cells Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0006931) A Study to Evaluate and Compare Injections of Autologous Mixed Population of Dermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0005995) A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0004669) A Study to Evaluate and Compare Injections of Autologous Mixed Population of Dermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0004542) A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0004541) To Investigate Efficacy of FOL-005 on Hair Growth on Scalp Skin Computer-Assisted Hair Implantation Using ARTAS System VS Manual Implantation Technique Hair Restoration Study To Evaluate the Pharmacokinetics and Safety of AD-208 The Utility of Platelet Rich Plasma in Hair Loss Computer-Assisted Versus Manual Hair Harvest Comparative Study Topical Bimatoprost Effect on Androgen Dependent Hair Follicles Efficacy Study of Minoxidil Lotion Versus Combined Minoxidil and Finasteride Lotion to Treat Male Pattern Hair Loss A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0004512) PAI-1 Expression in Non-scarring Hair Loss Split Wound Comparison of Trichophytic Closure Techniques for Donor Site in Hair Transplantation A Study to Evaluate the Effectiveness and Safety of 5 Percent Minoxidil Foam in the Treatment of Male Pattern Hair Loss Laser Assisted Delivery of Minoxidil in Androgenetic Alopecia Cold Plasma to Treat Hair Loss Adipose-derived SVF for Treatment of Alopecia Efficacy Study of Topical NEOSH101 to Treat Male Pattern Hair Loss Efficacy of Nutrition Supplement for Treatment of Men With Hair Loss Photosensitization Study in Androgenetic Alopecia Point-of-Care Adipose-derived Cells for Hair Growth Clinical Trial to Explore the Efficacy and Safety of DA-4001 After Topical Application Modulated Light Therapy in Participants With Pattern Hair Loss Pharmacokinetics/ Pharmacodynamics and Safety of DA-4001 in Healthy Male Subjects With Androgenic Alopecia N-Acetyl-Cysteine for Treatment of AGA in Men Clinical Trial in Females for Female Pattern Hair Loss Effects of Finasteride on Serum Prostate-Specific Antigen (0906-111) Effect of Pumpkin Seed Oil on Hair Growth in Men With Androgenetic Alopecia Evaluating the Topical Herbal Solution on the Treatment of Male Pattern Hair Loss and Comparison With Minoxidil 5% Treatment of Androgenetic Alopecia in Males and Females Microarray Analysis of Scalp Biopsies After Minoxidil Treatment Efficacy of Platelet-Rich Plasma Therapy for Androgenetic Alopecia: A Systematic Review and Meta-analysis 24 Week Clinical Trial to Evaluate Safety and Effectiveness of a Hair Growth System to Treat Male and Female Baldness A Randomized, Double-blind Clinical Trial to Evaluate the Safety and Efficacy of the X5 HairLaser for the Treatment of Androgenetic Alopecia in Males Dose-Ranging Efficacy Study of Topical NEOSH101 to Treat Male Pattern Hair Loss Minoxidil Response Testing in Males With Androgenetic Alopecia Follicular Revival in Androgenic Alopecia: Evaluating Use of Micro-needling A Novel Approach to Treating Androgenetic Alopecia in Females With Low Level Laser Therapy Study To Determine Safety & Efficacy Of Autologous Human Platelet Lysate in Androgenetic Alopecia After Hair Transplant Effectiveness and Safety of Minoxidil Foam Versus Placebo Foam for Androgenetic Alopecia Study to Assess Efficacy of Platelet-Rich Plasma in Androgenetic Alopecia The Effect of Allogeneic Human Adipose Derived Stem Cell Component Extract on Androgenic Alopecia A Study of the Safety, Tolerability, and Efficacy of Topical SM04554 Solution in Male Subjects With Androgenetic Alopecia (AGA) Evaluating the Efficacy of Microneedling in the Treatment of Androgenetic Alopecia A Phase 2 Study to Evaluate the Safety and Efficacy of CB-03-01 Solution, a Comparator Solution and Vehicle Solution in Males With Androgenetic Alopecia The Use of 5mg Finasteride Versus 200mg Spironolactone and Topical 5% Minoxidil in Treating Postmenopausal Female Androgenetic Alopecia A Study to Determine the Safety and Efficacy of Autologous Human Platelet Lysate for Treatment of Androgenetic Alopecia A Study in Male and Female Subjects With Androgenetic Alopecia Treated With ATI-50002 Topical Solution Treatment of Androgenetic Alopecia in Females, 9 Beam Treatment of Androgenetic Alopecia in Males With Theradome™ LH80 PRO Comparing Different Platelet Rich Plasma (PRP) Treatment Regimens for Management of Androgenic Alopecia Local Pharmacokinetics and Tolerability of Bimatoprost Applied to the Scalp of Male Patients With Androgenetic Alopecia Dutasteride Versus Placebo and Finasteride in Men With Androgenetic Alopecia Safety and Efficacy of Hair Stimulating Complex (HSC) on Hair Growth in Males With Androgenetic Alopecia Hair Growth Efficacy and Safety of NGF-574H in Adult With Androgenic Alopecia Plasma Rich in Growth Factors (PRGF-Endoret)in the Treatment of Androgenetic Alopecia Evaluating the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Androgenic Alopecia Efficacy and Safety Study to Compare Two Minoxidil Formulations on Women With Androgenetic Alopecia A Study of SM04554 Applied Topically to the Scalp of Male Subjects With Androgenetic Alopecia Analyzed by Biopsy of the Scalp Prior To and Post Dosing Treatment of Androgenetic Alopecia in Males Adipose Derived Stem Cells Versus Platelet Rich Plasma on Follicular Unit Extraction Treatment of Androgenetic Alopecia in Females, 12 Beam Nanofat Grafting for Treatment of Androgenetic Alopecia Topical Cetirizine 1% vs Minoxidil 5% Gel in Treatment of Androgenetic Alopecia Efficacy Study of a Cosmetic Lotion in the Treatment of Androgenetic Alopecia in Males and Females Treatment of Androgenic Alopecia in Males A Study Evaluating the Efficacy and Safety of SM04554 Topical Solution in Male Subjects With Androgenetic Alopecia Androgenetic Alopecia and the JAK-STAT Pathway Evaluate the Clinical Effectiveness of RegenKit Platelet-rich Plasma (PRP) in Androgenetic Alopecia Treatment Efficacy and Safety of Platelet Rich Plasma in Androgenetic Alopecia The Effect of Platelet-rich Plasma in Subjects With Androgenetic Alopecia

Brief Title

Clinical Trial in Females for Female Pattern Hair Loss

Official 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)

Brief Summary

      This is a six month clinical trial to evaluate the effectiveness and safety in women with
      Female Pattern Hair Loss (FPHL), comparing a 5% minoxidil topical foam (MTF) formulation
      applied once a day versus a topical foam vehicle (placebo) formulation applied once a day.
    

Detailed Description

      This is a phase 3, two-arm, randomized, double-blind, vehicle-controlled, multi-center,
      24-week, parallel design trial to evaluate the efficacy and safety in women with Female
      Pattern Hair Loss (FPHL), comparing the 5% MTF formulation versus the foam vehicle
      formulation.

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

      Study centers will screen a sufficient number of participants so that a minimum of 300 female
      participants with FPHL will be enrolled, to ensure 260 complete. There will be at least 16
      participants enrolled per center at multiple centers located across the US and globally.
      Approximately 300 participants will be randomly assigned in a 1:1 ratio to use either 5% MTF
      OD or foam vehicle OD, for 24 weeks for efficacy and safety evaluations.

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

      During the trial following enrollment at Baseline, participants will return to the study site
      at Weeks 1, 6, 12, 18 and 24 for safety assessments, adverse events monitoring, and
      compliance assessments. At the Week 12 and 24 visits, efficacy assessments will also be
      conducted, using Target Area Hair Counts (TAHC), measured by macrophotography.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Target Area Hair Count

Secondary Outcome

 Target Area Hair Count

Condition

Androgenetic Alopecia

Intervention

5% Minoxidil Topical Foam

Study Arms / Comparison Groups

 Minoxidil Foam
Description:  5% Minoxidil Topical Foam

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

404

Start Date

September 2010

Completion Date

August 2011

Primary Completion Date

August 2011

Eligibility Criteria

        Inclusion Criteria:

          -  females, age 18 or older in general good health

          -  exhibits female pattern hair loss

          -  signs and dates an informed consent document

          -  agrees to use an adequate method of birth control; if of childbearing potential

          -  shows a negative urine pregnancy test at Screening Visit

          -  is willing to maintain the same hair style, hair color, and hair regimen throughout
             the study

          -  is willing and able to comply with scheduled visits, treatment plan, laboratory tests
             and other trial procedures

        Exclusion Criteria:

          -  hypersensitivity to the (study product), or any ingredients of the (study product)

          -  known allergy to hair dye, or hair dye components

          -  clinically relevant history of hypotension

          -  untreated or uncontrolled hypertension

          -  pregnant, planning a pregnancy or nursing a child

          -  history of hair transplants

          -  currently use hair weaves or non-breathable wigs

          -  dermatologic disorders of the scalp that require chronic use of medication for control

          -  other types or history of hair loss

          -  enrolled in any other investigational medication (drug) study currently, or within the
             last 6 months
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Clare Kendall, , 

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT01226459

Organization ID

MINALO3005

Secondary IDs

2010-019881-96

Responsible Party

Sponsor

Study Sponsor

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

Collaborators

 Johnson & Johnson Consumer and Personal Products Worldwide

Study Sponsor

Clare Kendall, Study Director, Johnson & Johnson Consumer and Personal Products Worldwide


Verification Date

June 2014