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 CountSensitivity 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 CountSensitivity 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
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