Study to Investigate the Effectiveness of a Topical Cosme... | NCT06095739

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

NCT06095739

Sponsor

Applied Biology, Inc.

Status

Completed

Last Update Posted

Oct 23, 2023Actual

Enrollment

76Actual

Phase

Not Applicable

Conditions

Hair Diseases
Alopecia
Hair Loss

Interventions

DA-OTC-002

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 18, 2022Actual

Primary Completion Date

Jan 2, 2023Actual

Completion Date

Jan 2, 2023Actual

First Submitted Date

Oct 11, 2023

First Submission Date that Met QC Criteria

Oct 17, 2023

First Posted Date

Oct 23, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 20, 2023

Last Update Posted Date

Oct 23, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

76Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Daniel Fonesca	Applied Biology	Principal Investigator

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006201	Hair Diseases
D000505	Alopecia

Ancestor Terms

ID	Term
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D007039	Hypotrichosis
D020763	Pathological Conditions, Anatomical

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Browse Branches

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