Status:
COMPLETED
Study to Investigate the Effectiveness of a Topical Cosmetic Formulation DA-OTC-002
Lead Sponsor:
Applied Biology, Inc.
Conditions:
Hair Diseases
Alopecia
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
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-b...
Detailed Description
76 female subjects were included in the study. Subjects were otherwise healthy females, aged 18 years are older, and had ample hair on the scalp to allow application of test article. Subjects with an ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 2 2023
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT06095739
Start Date
November 18 2022
End Date
January 2 2023
Last Update
October 23 2023
Active Locations (1)
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1
Hospital Oscar Nicolau
Manaus, Brazil