Clinical trial NCT02198261: Minoxidil Response Testing in Males With Androgenetic Alopecia
Official title: Minoxidil Response Testing in Males With Androgenetic Alopecia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Androgenetic Alopecia
Keywords: alopecia
androgenetic alopecia
hair loss
minoxidil
5% minoxidil foam
male pattern hair loss
Lead sponsor: Applied Biology, Inc.
Sponsor class: INDUSTRY
First posted: 2014-07-23
Enrollment: 300
Sex: MALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Males with androgenetic alopecia

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.


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

Primary outcomes:
measure: 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
timeFrame: baseline to week 16
measure: Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the subjects ratings
timeFrame: baseline to week 16
Secondary outcomes:
measure: 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
timeFrame: baseline to week 16
measure: 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
timeFrame: baseline to week 16
measure: Mean change in minoxidil sulfotransferase activity in plucked hairs as measured by the minoxidil response in-vitro diagnostic kit
timeFrame: baseline to week 16
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Physicians Hair Institute
state: Arizona
city: Nashville
country: United States
facility: Tennessee Clinical Research Center
state: Tennessee
city: East Melbourne
country: Australia
facility: Sinclair Dermatology
city: Mumbai
country: India
facility: LTM Medical College & Hospital
city: Florence
country: Italy
facility: Istituto Medico Tricologico/Studi Life Cronos
Study officials:
affiliation: Physicians Hair Institute
name: Sharon Keene, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Istituto Medico Tricologico/Studi Life Cronos
name: Flavio Grasso, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sinclair Dermatology
name: Rodney Sinclair, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.