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.

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Key information

Conditions

Hair Diseases Alopecia Hair Loss Hypotrichosis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Oscar Nicolau

Manaus, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

Reduction in Hair Shedding Assessed by Target Area Hair Count Shedding

Time frame: 30 minutes

The average reduction in target area hair count after application of DA-OTC-002

Sponsors and collaborators

Lead sponsor

Applied Biology, Inc.

Industry

Registry information

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Oct 23, 2023
Registry last updated: Oct 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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