Alopecia Clinical Trial
Official title:
Minoxidil Response Testing in Females With Female Pattern Hair Loss
NCT number | NCT02206802 |
Other study ID # | AB-IVD-MINOXIDIL-004 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 2014 |
Est. completion date | October 2018 |
Verified date | October 2018 |
Source | Applied Biology, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The primary purpose of this study is to evaluate the clinical validity of the minoxidil response in-vitro diagnostic kit.
Status | Completed |
Enrollment | 300 |
Est. completion date | October 2018 |
Est. primary completion date | October 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Australia | Sinclair Dermatology | East Melbourne | |
India | LTM Medical College & Hospital | Mumbai | |
Italy | Istituto Medico Tricologico/Studi Life Cronos | Florence | |
United States | Tennessee Clinical Research Center | Nashville | Tennessee |
United States | Physicians Hair Institute | Tucson | Arizona |
Lead Sponsor | Collaborator |
---|---|
Applied Biology, Inc. |
United States, Australia, India, Italy,
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. — View Citation
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. — View Citation
Messenger AG, Rundegren J. Minoxidil: mechanisms of action on hair growth. Br J Dermatol. 2004 Feb;150(2):186-94. Review. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the change in Target Area Hair Count | Number of hairs measured in the target area by macrophotography. | baseline to week 24 | |
Primary | Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the subjects ratings | baseline to week 24 | ||
Secondary | Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the change in Target Area Hair Count | Number of hairs measured in the target area by macrophotography. | baseline to week 12 | |
Secondary | 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 24 | ||
Secondary | 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 24 | ||
Secondary | Mean change in minoxidil sulfotransferase activity in plucked hairs as measured by the minoxidil response in-vitro diagnostic kit | baseline to week 24 |
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