Minoxidil Response Testing in Females With Female Pattern Hair Loss

• Sponsor: Applied Biology, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02206802
• Collaborator: (none)
• Enrollment: 300
• Locations: 5
• Duration (Months): 51
• Patients Per Site: 60
• Patients Per Site Per Month: 1.2

Study Details

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	Phase
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
• Anticipated 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: Jul 1, 2014
• Actual Primary Completion Date: Oct 1, 2018
• Actual Study Completion Date: Oct 1, 2018

Arms and Interventions

Arm	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 [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 [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 [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 [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 [baseline to week 24]

4. Mean change in minoxidil sulfotransferase activity in plucked hairs as measured by the minoxidil response in-vitro diagnostic kit [baseline to week 24]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

	Site	City	State	Country	Postal Code
1	Physicians Hair Institute	Tucson	Arizona	United States	85719
2	Tennessee Clinical Research Center	Nashville	Tennessee	United States	37215
3	Sinclair Dermatology	East Melbourne		Australia	3002
4	LTM Medical College & Hospital	Mumbai		India	400022
5	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

Study Documents (Full-Text)

None provided.

More Information

Publications

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

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

Study Results

No Results Posted as of Oct 5, 2018