Clinical Study of DA-001 as a Treatment for Hair Shedding Reduction and Hair Re-Growth

NCT06648850 | Not Yet Recruiting Phase 2

• 1 other identifier: DA-001-TE
• Study Type: interventional
• Target: 1,120
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of the study is to assess the safety and efficacy of DA-001 as a treatment for Hair Shedding Reduction and Hair Re-Growth

Conditions

Telogen Effluvium; Female Pattern Hair Loss; Female Pattern Hair Loss, Androgenic Alopecia; Male Pattern Baldness; Androgenetic Alopecia; Androgenetic Alopecia (AGA)

Keywords

Hair Shedding; hair growth

Outcome Measures

Primary Outcomes (1)

• Mean Change in Hair Shedding

  Number of hairs shedding during brushing at target area

  Minutes [0,5]

Secondary Outcomes (2)

• Mean Change in Hair Shedding

  Week [0, 4, 12, 24]

• Mean Change in Target Area Hair Count (TAHC)

  Week [0, 4, 12, 24]

Study Arms (7)

DA-001 Topical

EXPERIMENTAL

Phenylephrine 2.5% Topical + TAAR agonist

Drug: DA-001

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Phenylephrine Topical

EXPERIMENTAL

Phenylephrine 2.5% Topical (per application volume - males 5mL and females 20mL)

Drug: Phenylephrine

DA-001 Topical + DA-005 Oral (HIF-1α supplement)

EXPERIMENTAL

DA-001 Topical (Phenylephrine 2.5% Topical + TAAR agonist tyramine) + DA-005 Oral (HIF-1α supplement)

Other: DA-001 Topical + DA-005 Oral (HIF-1α supplement)

DA-010 - Oral Phenylephrine 20 mg + DA-005 Oral (HIF-1α supplement)

EXPERIMENTAL

Oral Phenylephrine 20 mg + DA-005 Oral (HIF-1α supplement)

Other: DA-010 - Oral Phenylephrine 20 mg + DA-005 Oral (HIF-1α supplement)

Phenylephrine Topical 0.25% + Intact Pro Topical

EXPERIMENTAL

Phenylephrine Topical 0.25% + Intact Pro Topical

Drug: Phenylephrine Topical 0.25% + Intact Pro Topical

Phenylephrine + Intact Pro + DA-005 Oral (HIF-1α supplement)

EXPERIMENTAL

Phenylephrine + Intact Pro + DA-005 Oral (HIF-1α supplement)

Other: Phenylephrine + Intact Pro + DA-005 Oral (HIF-1α supplement)

Interventions

Placebo OTHER

Placebo Topical Solution

Placebo

DA-001 Topical + DA-005 Oral (HIF-1α supplement) OTHER

DA-001 Topical (Phenylephrine 2.5% Topical + TAAR agonist tyramine) + DA-005 Oral (HIF-1α supplement)

DA-001 Topical + DA-005 Oral (HIF-1α supplement)

Phenylephrine + Intact Pro + DA-005 Oral (HIF-1α supplement) OTHER

Phenylephrine 0.25% + Intact Pro (50% stronger) + DA-005 Oral (HIF-1α supplement)

Phenylephrine + Intact Pro + DA-005 Oral (HIF-1α supplement)

DA-001 DRUG

Phenylephrine 2.5% Topical + TAAR Agonist (GRAS) Topical Solution

DA-001 Topical

Phenylephrine DRUG

Phenylephrine 2.5% Topical

Phenylephrine Topical

DA-010 - Oral Phenylephrine 20 mg + DA-005 Oral (HIF-1α supplement) OTHER

Oral Phenylephrine 20 mg + DA-005 Oral (HIF-1α supplement)

DA-010 - Oral Phenylephrine 20 mg + DA-005 Oral (HIF-1α supplement)

Phenylephrine Topical 0.25% + Intact Pro Topical DRUG

Phenylephrine 0.25% + Intact Pro (50% stronger)

Phenylephrine Topical 0.25% + Intact Pro Topical

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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-001
• 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

Sponsors & Collaborators

• Applied Biology, Inc.: lead
• Follea International Limited: collaborator
• Daniel Alain, Inc.: collaborator

Related Links

• Daniel Alain, Inc. - Updated Study Information

MeSH Terms

Conditions

Alopecia

Interventions

Phenylephrine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Study Officials

• Andy Goren, MD

  University of Rome G. Marconi

  STUDY DIRECTOR

Central Study Contacts

Andy Goren, MD

CONTACT

16507040850; clinicalstudies@appliedbiology.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: October 18, 2024
• Study Start: May 1, 2026
• Primary Completion (Estimated): March 19, 2027
• Study Completion (Estimated): April 26, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share