Alopecia Clinical Trial
Official title:
Study to Investigate the Effectiveness of a Topical Cosmetic Formulation DA-OTC-002
Verified date | October 2023 |
Source | Applied Biology, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary objective of the study was to assess the efficacy of DA-OTC-002 as a topical cosmetic hair treatment. The investigators conducted a prospective, institution-level, interventional, single-blinded, placebo-controlled investigation to assess the efficacy of a combination an alpha-1 agonist and a TAAR receptor agonist (DA-OTC-002) as a topical cosmetic hair treatment.
Status | Completed |
Enrollment | 76 |
Est. completion date | January 2, 2023 |
Est. primary completion date | January 2, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Females Age 18 or older - Willing and able to apply the treatment as directed, comply with study - Subject has ample hair on the scalp to allow application of test article - Otherwise healthy. - Able to give informed consent Exclusion Criteria: - A medical history that may interfere with study objectives. - Subjects with any dermatologic disease in the treatment area. - Women who are pregnant, lactating, or planning to become pregnant during the study period. - Subjects who have experienced a clinically important medical event within 90 days of the visit (e.g., stroke, myocardial infarction, etc). - Subjects who are actively treated for hypertension. - Subjects who have known allergies to any excipient in DA-OTC-002 - Subjects who are currently participating in another clinical study or have completed another clinical study with an investigational drug or device in the treatment area within 30 days prior to study treatment initiation. - Subjects who have used any topical prescription medications in the treatment area within 30 days prior to study treatment initiation. - Subjects who have had a dermatological procedure such as surgery in the treatment area within 30 days prior to study treatment initiation. - Subject is unable to provide consent or make the allotted clinical visits. |
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital Oscar Nicolau | Manaus |
Lead Sponsor | Collaborator |
---|---|
Applied Biology, Inc. |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction in Hair Shedding Assessed by Target Area Hair Count Shedding | The average reduction in target area hair count after application of DA-OTC-002 | 30 minutes |
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