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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02198261 |
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Date of registration:
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21/07/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Minoxidil Response Testing in Males With Androgenetic Alopecia
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Scientific title:
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Minoxidil Response Testing in Males With Androgenetic Alopecia |
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Date of first enrolment:
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July 2014 |
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Target sample size:
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300 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02198261 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Australia
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India
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Italy
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United States
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Contacts
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Name:
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Sharon Keene, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Physicians Hair Institute |
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Name:
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Flavio Grasso, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Istituto Medico Tricologico/Studi Life Cronos |
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Name:
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Rodney Sinclair, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sinclair Dermatology |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
49 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Androgenetic Alopecia
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Intervention(s)
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Drug: 5% minoxidil topical foam
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Primary Outcome(s)
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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
[Time Frame: baseline to week 16]
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Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the subjects ratings
[Time Frame: baseline to week 16]
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Secondary Outcome(s)
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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 16]
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Mean change in minoxidil sulfotransferase activity in plucked hairs as measured by the minoxidil response in-vitro diagnostic kit
[Time Frame: baseline to week 16]
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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 16]
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Secondary ID(s)
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AB-IVD-MINOXIDIL-003
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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