Minoxidil Response Testing in Females With Female Pattern Hair Loss

NCT ID: NCT02206802

Last Updated: 2018-10-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2018-10-31

Brief Summary

The primary purpose of this study is to evaluate the clinical validity of the minoxidil response in-vitro diagnostic kit.

Detailed Description

Topical minoxidil is the only US FDA approved drug used for the treatment of AGA in females. While topical minoxidil exhibits a good safety profile, the efficacy in the overall population remains relatively low i.e., 30-40% re-grow hair. To observe significant improvement in hair growth, minoxidil is typically used once daily for a period of at least 24 weeks. Due to the significant time commitment and low response rate, a diagnostic test to identify non-responders prior to initiating therapy would be advantageous.

Minoxidil is converted in the scalp to its active form, minoxidil sulfate, by the sulfotransferase enzyme SULT1A1. The enzyme expression is variable among individuals. We have demonstrated in two prior feasibility studies that the SULT1A1 enzyme activity in plucked hair follicles correlates with minoxidil response in the treatment of AGA and thus can server as a predictive biomarker.

Consequently, we developed a minoxidil response in-vitro diagnostic kit intended to identify non-responders prior to initiating therapy with 5% topical minoxidil foam.

Conditions

Alopecia; Female Pattern Hair Loss

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Predicted as non-responders

Patients that the minoxidil response in-vitro diagnostic kit predicted as non-responders. 5% minoxidil topical foam will be administered to subjects in this group.

5% minoxidil topical foam

Intervention Type: DRUG

5% minoxidil topical foam

Predicted as responders

Patients that the minoxidil response in-vitro diagnostic kit predicted as responders. 5% minoxidil topical foam will be administered to subjects in this group.

5% minoxidil topical foam

Intervention Type: DRUG

5% minoxidil topical foam

Interventions

5% minoxidil topical foam

5% minoxidil topical foam

Intervention Type: DRUG

Other Intervention Names

Rogaine 5% minoxidil foam; Regaine 5% minoxidil foam

Eligibility Criteria

Inclusion Criteria

• Females in overall good health
• Age: 18 or older
• Female pattern hair loss
• Willing to have a mini dot tattoo placed in the target area of the scalp
• Willing to maintain the same hair style, color, shampoo and hair products use, and approximate hair length throughout the study
• Able to give informed consent
• Able to comply with the study requirements for 24 consecutive weeks
• Willing to use an adequate method of birth control (if applicable)
• Negative urine pregnancy test

Exclusion Criteria

• Previous adverse event from topical minoxidil treatment
• History of hypotension
• Uncontrolled hypertension
• Pregnant, nursing, or planning a pregnancy during the study
• Prior hair transplant
• Uses wigs or hair weaves
• Have used minoxidil (topical or oral) anytime during the past 6 months
• Chronic scalp disorders that require medications
• Uses medication known to cause hair thinning such as Coumadin and anti-depressants/anti-psychotics
• Folliculitis
• Scalp psoriasis
• Seborrheic dermatitis
• Inflammatory scalp conditions such as lichen planopilaris
• Enrolled in any other medical study or has been enrolled in any medical study in the past 6 months

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Applied Biology, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sharon Keene, MD

Role: PRINCIPAL_INVESTIGATOR

Physicians Hair Institute

Flavio Grasso, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Medico Tricologico/Studi Life Cronos

Rodney Sinclair, MD

Role: PRINCIPAL_INVESTIGATOR

Sinclair Dermatology

Rachita Dhurat, MD

Role: PRINCIPAL_INVESTIGATOR

LTM Medical College & Hospital

Locations

Physicians Hair Institute

Tucson, Arizona, United States

Tennessee Clinical Research Center

Nashville, Tennessee, United States

Sinclair Dermatology

East Melbourne, , Australia

LTM Medical College & Hospital

Mumbai, , India

Istituto Medico Tricologico/Studi Life Cronos

Florence, , Italy

Countries

United States; Australia; India; Italy

References

Roberts J, Desai N, McCoy J, Goren A. Sulfotransferase activity in plucked hair follicles predicts response to topical minoxidil in the treatment of female androgenetic alopecia. Dermatol Ther. 2014 Jul-Aug;27(4):252-4. doi: 10.1111/dth.12130. Epub 2014 Apr 28.

Reference Type: BACKGROUND

PMID: 24773771 (View on PubMed)

Goren A, Castano JA, McCoy J, Bermudez F, Lotti T. Novel enzymatic assay predicts minoxidil response in the treatment of androgenetic alopecia. Dermatol Ther. 2014 May-Jun;27(3):171-3. doi: 10.1111/dth.12111. Epub 2013 Nov 27.

Reference Type: BACKGROUND

PMID: 24283387 (View on PubMed)

Buhl AE, Waldon DJ, Baker CA, Johnson GA. Minoxidil sulfate is the active metabolite that stimulates hair follicles. J Invest Dermatol. 1990 Nov;95(5):553-7. doi: 10.1111/1523-1747.ep12504905.

Reference Type: BACKGROUND

PMID: 2230218 (View on PubMed)

Messenger AG, Rundegren J. Minoxidil: mechanisms of action on hair growth. Br J Dermatol. 2004 Feb;150(2):186-94. doi: 10.1111/j.1365-2133.2004.05785.x.

Reference Type: BACKGROUND

PMID: 14996087 (View on PubMed)

Other Identifiers

AB-IVD-MINOXIDIL-004

Identifier Type: -

Identifier Source: org_study_id