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

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.

Study Overview

• Status: Completed
• Conditions: Alopecia; Hair Diseases; Hair Loss
• Intervention / Treatment: Combination product: DA-OTC-002

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 Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Manaus, Brazil
    • Hospital Oscar Nicolau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Combination product: DA-OTC-002; The topical formula of DA-OTC-002 was formed from 2 molecules: an alpha 1 agonist (synephrine) and a TAAR receptor agonist A 1mL topical application of DA-OTC-002 was applied to a 10cm x 10xm target area of the right side of the scalp of each subject

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Applied Biology, Inc.
• Investigators: Principal Investigator: Daniel Fonesca, Applied Biology

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2022
• Primary Completion (Actual): January 2, 2023
• Study Completion (Actual): January 2, 2023

Study Registration Dates

• First Submitted: October 11, 2023
• First Submitted That Met QC Criteria: October 17, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 20, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Alopecia; Hair Diseases
• Other Study ID Numbers: AppliedBiology

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No