Minoxidil Response Testing in Males With Androgenetic Alopecia
Information source: Applied Biology, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Androgenetic Alopecia
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
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.
Clinical Details
Official title: Minoxidil Response Testing in Males With Androgenetic Alopecia
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 mean change in non-vellus hair count in the target regionSensitivity 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 treatment efficacy evaluated by expert panel review of global photographs assessing hair regrowthSensitivity 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
Eligibility
Minimum age: 18 Years.
Maximum age: 49 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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
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