Study to Investigate the Effectiveness of a Topical Cosmetic Formulation DA-OTC-002

Not Applicable

Completed

• Conditions: Hair Diseases; Alopecia; Hair Loss
• Interventions: Combination Product: DA-OTC-002

• Registration Number: NCT06095739
• Lead Sponsor: Applied Biology, Inc.

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.

Study Timeline

• Study Start: 2022-11-18
• Primary Completion: 2023-01-02
• Study Completion: 2023-01-02
• Status Verified: 2023-10
• Study First Submitted: 2023-10-11
• Study First Submitted QC: 2023-10-17
• Last Update Submitted: 2023-10-20
• Study First Posted: 2023-10-23
• Last Update Posted: 2023-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 76

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DA-OTC-002	DA-OTC-002	A 1mL topical application of DA-OTC-002 solution was applied to a 10cm x 10xm target area of the left side of the scalp of each subject.

Primary Outcome Measures

Name	Time	Method
Reduction in Hair Shedding Assessed by Target Area Hair Count Shedding	30 minutes	The average reduction in target area hair count after application of DA-OTC-002

Trial Locations

Locations (1)

Hospital Oscar Nicolau; 🇧🇷 Manaus, Brazil