Minoxidil Response Testing in Males With Androgenetic Alopecia

Androgenetic Alopecia Clinical Trial

Official title:

Minoxidil Response Testing in Males With Androgenetic Alopecia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02198261
• Other study ID #: AB-IVD-MINOXIDIL-003
• Status: Completed
• Start date: July 2014
• Est. completion date: October 2018

Study information

• Verified date: October 2018
• Source: Applied Biology, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Androgenetic Alopecia

Intervention

Drug:
• 5% minoxidil topical foam
5% minoxidil topical foam

Locations

Country	Name	City	State
Australia	Sinclair Dermatology	East Melbourne
India	LTM Medical College & Hospital	Mumbai
Italy	Istituto Medico Tricologico/Studi Life Cronos	Florence
United States	Tennessee Clinical Research Center	Nashville	Tennessee
United States	Physicians Hair Institute	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Applied Biology, Inc.

Countries where clinical trial is conducted

United States,  Australia,  India,  Italy, 

References & Publications (4)

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. — View 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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		baseline to week 16
Primary	Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the subjects ratings		baseline to week 16
Secondary	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		baseline to week 16
Secondary	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		baseline to week 16
Secondary	Mean change in minoxidil sulfotransferase activity in plucked hairs as measured by the minoxidil response in-vitro diagnostic kit		baseline to week 16