Minoxidil Response Testing in Males With Androgenetic Alopecia

NCT02198261 | Completed

• 1 other identifier: AB-IVD-MINOXIDIL-003
• Study Type: observational
• Target: 300
• Locations: 4 countries
• Sites: 5

Brief 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.

Conditions

Androgenetic Alopecia

Keywords

alopecia; androgenetic alopecia; hair loss; minoxidil; 5% minoxidil foam; male pattern hair loss

Outcome Measures

Primary Outcomes (2)

• 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

• Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the subjects ratings

  baseline to week 16

Secondary Outcomes (3)

• 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

• 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

• Mean change in minoxidil sulfotransferase activity in plucked hairs as measured by the minoxidil response in-vitro diagnostic kit

  baseline to week 16

Study Arms (2)

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

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

Interventions

5% minoxidil topical foam DRUG

5% minoxidil topical foam

Also known as: Rogaine 5% minoxidil foam, Regaine 5% minoxidil foam

Predicted as non-responders; Predicted as responders

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Males with androgenetic alopecia

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Applied Biology, Inc.: lead

Study Sites (5)

Physicians Hair Institute

Tucson, Arizona, 85719, United States

Location

Tennessee Clinical Research Center

Nashville, Tennessee, 37215, United States

Location

Sinclair Dermatology

East Melbourne, 3002, Australia

Location

LTM Medical College & Hospital

Mumbai, 400022, India

Location

Istituto Medico Tricologico/Studi Life Cronos

Florence, 50127, Italy

Location

Related Publications (4)

• 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.

  PMID: 24773771 BACKGROUND

• 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.

  PMID: 24283387 BACKGROUND

• 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.

  PMID: 2230218 BACKGROUND

• 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.

  PMID: 14996087 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plucked hair follicles with visible bulbs

MeSH Terms

Conditions

Alopecia

Interventions

Minoxidil

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• 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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2014
• First Posted: July 23, 2014
• Study Start: July 1, 2014
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: October 5, 2018

Record last verified: 2018-10

Locations

US (2); AU (1); IN (1); IT (1)