Minoxidil Response Testing in Males With Androgenetic Alopecia

NCT ID: NCT02198261

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

Topical minoxidil is the most common drug used for the treatment of AGA in men. 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 twice daily for a period of at least 16 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.

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

Conditions

Androgenetic Alopecia

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

• Males in overall good health
• Age: 18 to 49
• Diagnosed with male androgenetic alopecia with vertex pattern IIIv, IV, or V on the Norwood Hamilton Scale
• 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 16 consecutive weeks

Exclusion Criteria

• Previous adverse event from topical minoxidil treatment
• Does not use and have not used in the past 6 months anti-androgen therapy such as finasteride
• Does not use and have not used in the past 6 months minoxidil (topical or oral)
• Does not take 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: MALE
• 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

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-003

Identifier Type: -

Identifier Source: org_study_id