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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT02206802 |
Date of registration:
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31/07/2014 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Minoxidil Response Testing in Females With Female Pattern Hair Loss
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Scientific title:
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Minoxidil Response Testing in Females With Female Pattern Hair Loss |
Date of first enrolment:
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July 2014 |
Target sample size:
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300 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02206802 |
Study type:
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Observational |
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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Flavio Grasso, MD |
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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Sharon Keene, MD |
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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Rachita Dhurat, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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LTM Medical College & Hospital |
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Name:
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Rodney Sinclair, MD |
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:
- 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Female Pattern Hair Loss
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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 change in Target Area Hair Count
[Time Frame: baseline to week 24]
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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 24]
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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 24]
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Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the change in Target Area Hair Count
[Time Frame: baseline to week 12]
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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 24]
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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 24]
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Secondary ID(s)
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AB-IVD-MINOXIDIL-004
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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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