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

Alopecia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06095739
• Other study ID #: AppliedBiology
• Status: Completed
• Phase: N/A
• Start date: November 18, 2022
• Est. completion date: January 2, 2023

Study information

• Verified date: October 2023
• Source: Applied Biology, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: January 2, 2023
• Est. primary completion date: January 2, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alopecia
• Hair Loss

Intervention

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

Locations

Country	Name	City	State
Brazil	Hospital Oscar Nicolau	Manaus

Sponsors (1)

Lead Sponsor	Collaborator
Applied Biology, Inc.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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