Minoxidil Response Testing in Males With Androgenetic Alopecia

• ClinicalTrials.gov Identifier: NCT02198261
• Recruitment Status: Completed
• First Posted: July 23, 2014
• Last Update Posted: October 5, 2018
• Sponsor: Applied Biology, Inc.
• Information provided by (Responsible Party): Applied Biology, Inc.

Study Description

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.

Condition or disease	Intervention/treatment
Androgenetic Alopecia	Drug: 5% minoxidil topical foam

Study Design

• Study Type: Observational
• Estimated Enrollment: 300 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Minoxidil Response Testing in Males With Androgenetic Alopecia
• Study Start Date: July 2014
• Actual Primary Completion Date: October 2018
• Actual Study Completion Date: October 2018

Groups and Cohorts

Group/Cohort	Intervention/treatment
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.	Drug: 5% minoxidil topical foam; 5% minoxidil topical foam; Other Names: Rogaine 5% minoxidil foam; Regaine 5% minoxidil 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.	Drug: 5% minoxidil topical foam; 5% minoxidil topical foam; Other Names: Rogaine 5% minoxidil foam; Regaine 5% minoxidil foam

Outcome Measures

Primary Outcome Measures :

1. Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the mean change in non-vellus hair count in the target region [ Time Frame: baseline to week 16 ]
2. Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the subjects ratings [ Time Frame: baseline to week 16 ]

Secondary Outcome Measures :

1. Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the treatment efficacy evaluated by expert panel review of global photographs assessing hair regrowth [ Time Frame: baseline to week 16 ]
2. Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the mean change in non-vellus hair diameter in the target region [ Time Frame: baseline to week 16 ]
3. Mean change in minoxidil sulfotransferase activity in plucked hairs as measured by the minoxidil response in-vitro diagnostic kit [ Time Frame: baseline to week 16 ]

Biospecimen Retention:   Samples Without DNA

Plucked hair follicles with visible bulbs

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 49 Years (Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Males with androgenetic alopecia

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

Contacts and Locations

Locations

United States, Arizona

Physicians Hair Institute

Tucson, Arizona, United States, 85719

United States, Tennessee

Tennessee Clinical Research Center

Nashville, Tennessee, United States, 37215

Australia

Sinclair Dermatology

East Melbourne, Australia, 3002

India

LTM Medical College & Hospital

Mumbai, India, 400022

Italy

Istituto Medico Tricologico/Studi Life Cronos

Florence, Italy, 50127

Sponsors and Collaborators

Applied Biology, Inc.

Investigators

• Principal Investigator: Sharon Keene, MD; Physicians Hair Institute
• Principal Investigator: Flavio Grasso, MD; Istituto Medico Tricologico/Studi Life Cronos
• Principal Investigator: Rodney Sinclair, MD; Sinclair Dermatology

More Information

Publications:

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.

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.

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.

Messenger AG, Rundegren J. Minoxidil: mechanisms of action on hair growth. Br J Dermatol. 2004 Feb;150(2):186-94. Review.

• Responsible Party: Applied Biology, Inc.
• ClinicalTrials.gov Identifier: NCT02198261
• Other Study ID Numbers: AB-IVD-MINOXIDIL-003
• First Posted: July 23, 2014
• Last Update Posted: October 5, 2018
• Last Verified: October 2018

Keywords provided by Applied Biology, Inc.:

alopecia; androgenetic alopecia; hair loss; minoxidil; 5% minoxidil foam; male pattern hair loss

Additional relevant MeSH terms:

Alopecia; Alopecia Areata; Hypotrichosis; Hair Diseases; Skin Diseases; Pathological Conditions, Anatomical; Minoxidil; Antihypertensive Agents; Vasodilator Agents