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Minoxidil Response Testing in Females With Female Pattern Hair Loss

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

Condition(s) targeted: Alopecia; Female Pattern Hair Loss

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
Rachita Dhurat, MD, Principal Investigator, Affiliation: LTM Medical College & Hospital

Summary

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 Females With Female Pattern Hair Loss

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 change in Target Area Hair Count

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 change in Target Area Hair Count

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

Detailed 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

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

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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