Minoxidil Response Testing in Females With Female Pattern Hair Loss

Alopecia Clinical Trial

Official title:

Minoxidil Response Testing in Females With Female Pattern Hair Loss

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02206802
• Other study ID #: AB-IVD-MINOXIDIL-004
• 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

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

Description:

Topical minoxidil is the only US FDA approved drug used for the treatment of AGA in females. 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 once daily for a period of at least 24 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Females in overall good health

• Age: 18 or older

• Female pattern hair loss

• 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 24 consecutive weeks

• Willing to use an adequate method of birth control (if applicable)

• Negative urine pregnancy test

Exclusion Criteria:

• Previous adverse event from topical minoxidil treatment

• History of hypotension

• Uncontrolled hypertension

• Pregnant, nursing, or planning a pregnancy during the study

• Prior hair transplant

• Uses wigs or hair weaves

• Have used minoxidil (topical or oral) anytime during the past 6 months

• Chronic scalp disorders that require medications

• Uses 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

• Enrolled in any other medical study or has been enrolled in any medical study in the past 6 months

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Female Pattern Hair Loss

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 change in Target Area Hair Count	Number of hairs measured in the target area by macrophotography.	baseline to week 24
Primary	Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the subjects ratings		baseline to week 24
Secondary	Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the change in Target Area Hair Count	Number of hairs measured in the target area by macrophotography.	baseline to week 12
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 24
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 24
Secondary	Mean change in minoxidil sulfotransferase activity in plucked hairs as measured by the minoxidil response in-vitro diagnostic kit		baseline to week 24