Minoxidil Response Testing in Females With Female Pattern Hair Loss

• ClinicalTrials.gov Identifier: NCT02206802
• Recruitment Status: Completed
• First Posted: August 1, 2014
• Last Update Posted: October 5, 2018
• Sponsor: Applied Biology, Inc.
• Information provided by (Responsible Party): Applied Biology, Inc.

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment
Alopecia; Female Pattern Hair Loss	Drug: 5% minoxidil topical foam

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.

Study Design

• Study Type: Observational
• Estimated Enrollment: 300 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Minoxidil Response Testing in Females With Female Pattern Hair Loss
• Study Start Date: July 2014
• Actual Primary Completion Date: October 2018
• Actual Study Completion Date: October 2018

Groups and Cohorts

Group/Cohort	Intervention/treatment
Predicted as non-responders; Patients that the minoxidil response in-vitro diagnostic kit predicted as non-responders. 5% minoxidil topical foam will be administered to subjects in this group.	Drug: 5% minoxidil topical foam; 5% minoxidil topical foam; Other Names: Rogaine 5% minoxidil foam; Regaine 5% minoxidil foam
Predicted as responders; Patients that the minoxidil response in-vitro diagnostic kit predicted as responders. 5% minoxidil topical foam will be administered to subjects in this group.	Drug: 5% minoxidil topical foam; 5% minoxidil topical foam; Other Names: Rogaine 5% minoxidil foam; Regaine 5% minoxidil foam

Outcome Measures

Primary Outcome Measures :

1. Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the change in Target Area Hair Count [ Time Frame: baseline to week 24 ]
   Number of hairs measured in the target area by macrophotography.
2. Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the subjects ratings [ Time Frame: baseline to week 24 ]

Secondary Outcome Measures :

1. Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the change in Target Area Hair Count [ Time Frame: baseline to week 12 ]
   Number of hairs measured in the target area by macrophotography.
2. 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 [ Time Frame: baseline to week 24 ]
3. 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 [ Time Frame: baseline to week 24 ]
4. Mean change in minoxidil sulfotransferase activity in plucked hairs as measured by the minoxidil response in-vitro diagnostic kit [ Time Frame: baseline to week 24 ]

Biospecimen Retention:   Samples Without DNA

Plucked hair follicles with visible bulbs

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Females with Female Pattern Hair Loss - Androgenetic Alopecia

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

Contacts and Locations

Locations

United States, Arizona

Physicians Hair Institute

Tucson, Arizona, United States, 85719

United States, Tennessee

Tennessee Clinical Research Center

Nashville, Tennessee, United States, 37215

Australia

Sinclair Dermatology

East Melbourne, Australia, 3002

India

LTM Medical College & Hospital

Mumbai, India, 400022

Italy

Istituto Medico Tricologico/Studi Life Cronos

Florence, Italy, 50127

Sponsors and Collaborators

Applied Biology, Inc.

Investigators

• Principal Investigator: Sharon Keene, MD; Physicians Hair Institute
• Principal Investigator: Flavio Grasso, MD; Istituto Medico Tricologico/Studi Life Cronos
• Principal Investigator: Rodney Sinclair, MD; Sinclair Dermatology
• Principal Investigator: Rachita Dhurat, MD; LTM Medical College & Hospital

More Information

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. doi: 10.1111/1523-1747.ep12504905.

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.

• Responsible Party: Applied Biology, Inc.
• ClinicalTrials.gov Identifier: NCT02206802
• Other Study ID Numbers: AB-IVD-MINOXIDIL-004
• First Posted: August 1, 2014
• Last Update Posted: October 5, 2018
• Last Verified: October 2018

Keywords provided by Applied Biology, Inc.:

Alopecia; Androgenetic Alopecia; Female Pattern Hair Loss; Hair Loss; Minoxidil; Hair Thinning

Additional relevant MeSH terms:

Alopecia; Alopecia Areata; Hypotrichosis; Hair Diseases; Skin Diseases; Pathological Conditions, Anatomical; Minoxidil; Antihypertensive Agents; Vasodilator Agents