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

Primary Purpose

Hair Diseases, Alopecia, Hair Loss

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
DA-OTC-002
Sponsored by
Applied Biology, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hair Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Hospital Oscar Nicolau

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DA-OTC-002

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 11, 2023
Last Updated
October 20, 2023
Sponsor
Applied Biology, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT06095739
Brief Title
Study to Investigate the Effectiveness of a Topical Cosmetic Formulation DA-OTC-002
Official Title
Study to Investigate the Effectiveness of a Topical Cosmetic Formulation DA-OTC-002
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
November 18, 2022 (Actual)
Primary Completion Date
January 2, 2023 (Actual)
Study Completion Date
January 2, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Applied Biology, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hair Diseases, Alopecia, Hair Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DA-OTC-002
Arm Type
Experimental
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
DA-OTC-002
Intervention Description
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 Outcome Measure Information:
Title
Reduction in Hair Shedding Assessed by Target Area Hair Count Shedding
Description
The average reduction in target area hair count after application of DA-OTC-002
Time Frame
30 minutes

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Fonesca
Organizational Affiliation
Applied Biology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Oscar Nicolau
City
Manaus
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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