Clinical trial NCT06095739: Study to Investigate the Effectiveness of a Topical Cosmetic Formulation DA-OTC-002
Official title: Study to Investigate the Effectiveness of a Topical Cosmetic Formulation DA-OTC-002
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hair Diseases
Alopecia
Hair Loss
Lead sponsor: Applied Biology, Inc.
Sponsor class: INDUSTRY
First posted: 2023-10-23
Enrollment: 76
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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-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.

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 interfering dermatologic disease or procedure, who were pregnant, lactating, or planning to become pregnant during the study, had experienced a clinically important medical event within 90 days of the visit, who were actively treated for hypertension, or had known allergies to any excipient in DA-OTC-002 were excluded from the study. This study was conducted in compliance with Good Clinical Practice, including the archival of essential documents. All subjects gave informed consent during the study enrollment.

Eligibility criteria: 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.

Primary outcomes:
measure: Reduction in Hair Shedding Assessed by Target Area Hair Count Shedding
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Manaus
country: Brazil
facility: Hospital Oscar Nicolau
Study officials:
affiliation: Applied Biology
name: Daniel Fonesca
role: PRINCIPAL_INVESTIGATOR
References: