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

NCT06095739 | Completed

• 1 other identifier: AppliedBiology
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Hair Diseases; Alopecia; Hair Loss

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

DA-OTC-002

EXPERIMENTAL

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

Interventions

DA-OTC-002 COMBINATION_PRODUCT

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

DA-OTC-002

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Applied Biology, Inc.: lead

Study Sites (1)

Hospital Oscar Nicolau

Manaus, Brazil

Location

MeSH Terms

Conditions

Hair Diseases; Alopecia

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Hypotrichosis; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel Fonesca

  Applied Biology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2023
• First Posted: October 23, 2023
• Study Start: November 18, 2022
• Primary Completion: January 2, 2023
• Study Completion: January 2, 2023
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)