MedDataX Logo

Clinical Study of DA-002 and DA-005 As a Treatment for Hair Loss

NCT ID: NCT06501924

Last Updated: 2024-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

516 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-15

Study Completion Date

2025-12-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The primary objective of the study is to assess the safety and efficacy of DA-005 and DA-002 as a treatment for hair loss (androgenetic alopecia).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

DA-005 is a botanical supplement with demonstrated HIF-1a inhibitory action. The ingredients were tested in-vitro and have demonstrated the HIF-1a inhibitory effect. The primary aim of the study is to compare DA-005 to topical minoxidil in the treatment of hair loss (also known as androgenetic alopecia).

DA-002 is a topical alpha 1 agonist. The ingredients were tested in-vitro and have demonstrated hair growth effects. The secondary aim of the study is to compare DA-002 to topical minoxidil in the treatment of hair loss (also known as androgenetic alopecia).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Androgenetic Alopecia Female Pattern Baldness Male Pattern Baldness

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

DA-005

Oral Botanical Supplement HIF-1a inhibitor

Group Type EXPERIMENTAL

DA-005

Intervention Type DIETARY_SUPPLEMENT

Oral Botanical Supplement HIF-1a inhibitor

Placebo Topical Solution

Intervention Type OTHER

Placebo Topical Solution

Topical Minoxidil 5%

Topical Minoxidil 5%

Group Type ACTIVE_COMPARATOR

Topical minoxidil 5%

Intervention Type DRUG

Topical minoxidil 5%

Placebo Oral Tablet

Intervention Type DIETARY_SUPPLEMENT

Placebo Oral Tablet

DA-002

Topical Alpha 1 Agonist

Group Type EXPERIMENTAL

DA-002

Intervention Type DRUG

Topical Alpha 1 Agonist (GRAS)

Placebo Oral Tablet

Intervention Type DIETARY_SUPPLEMENT

Placebo Oral Tablet

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

DA-005

Oral Botanical Supplement HIF-1a inhibitor

Intervention Type DIETARY_SUPPLEMENT

Topical minoxidil 5%

Topical minoxidil 5%

Intervention Type DRUG

DA-002

Topical Alpha 1 Agonist (GRAS)

Intervention Type DRUG

Placebo Oral Tablet

Placebo Oral Tablet

Intervention Type DIETARY_SUPPLEMENT

Placebo Topical Solution

Placebo Topical Solution

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Daniel Alain Botanical Supplement Treatment for Hair Loss

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age 18 or older
* Diagnosed with androgenetic alopecia
* Willing and able to apply the treatment as directed, comply with study
* Otherwise healthy
* Able to give informed consent

Exclusion Criteria

* A medical history that may interfere with study objectives
* 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 have known allergies to any excipient in DA-002 or DA-005
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Follea International Limited

INDUSTRY

Sponsor Role collaborator

Daniel Alain, Inc.

UNKNOWN

Sponsor Role collaborator

Applied Biology, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Andy Goren, MD

Role: STUDY_DIRECTOR

University of Rome G. Marconi

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Andy Goren, MD

Role: CONTACT

Phone: 16507040850

Email: [email protected]

Related Links

Access external resources that provide additional context or updates about the study.

http://www.danielalain.com

Daniel Alain, Inc. - Updated Study Information

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DA-005

Identifier Type: -

Identifier Source: org_study_id