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Minoxidil Response Testing in Males With Androgenetic Alopecia

Information source: Applied Biology, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Androgenetic Alopecia

Intervention: 5% minoxidil topical foam (Drug)

Phase: N/A

Status: Active, not recruiting

Sponsored by: Applied Biology, Inc.

Official(s) and/or principal investigator(s):
Sharon Keene, MD, Principal Investigator, Affiliation: Physicians Hair Institute
Flavio Grasso, MD, Principal Investigator, Affiliation: Istituto Medico Tricologico/Studi Life Cronos
Rodney Sinclair, MD, Principal Investigator, Affiliation: Sinclair Dermatology

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.

Clinical Details

Official title: Minoxidil Response Testing in Males With Androgenetic Alopecia

Study design: Observational Model: Case Control, Time Perspective: Prospective

Primary outcome:

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

Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the subjects ratings

Secondary outcome:

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

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

Mean change in minoxidil sulfotransferase activity in plucked hairs as measured by the minoxidil response in-vitro diagnostic kit

Eligibility

Minimum age: 18 Years. Maximum age: 49 Years. Gender(s): Male.

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

Locations and Contacts

Sinclair Dermatology, East Melbourne 3002, Australia

LTM Medical College & Hospital, Mumbai 400022, India

Istituto Medico Tricologico/Studi Life Cronos, Florence 50127, Italy

Physicians Hair Institute, Tucson, Arizona 85719, United States

Tennessee Clinical Research Center, Nashville, Tennessee 37215, United States

Additional Information

Related 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.

Starting date: July 2014
Last updated: June 18, 2015

Page last updated: August 23, 2015

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