Health TrialsbyHealthPanel

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

ConditionsTelogen EffluviumFemale Pattern Hair LossFemale Pattern Hair Loss, Androgenic AlopeciaMale Pattern BaldnessAndrogenetic AlopeciaAndrogenetic Alopecia (AGA)
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorApplied Biology, Inc.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 or older

Diagnosed with telogen effluvium

Willing and able to apply the treatment as directed, comply with study

Otherwise healthy

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • DA-001

    Drug

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

  • Placebo

    Other intervention

    Placebo Topical Solution

  • Phenylephrine

    Drug

    Phenylephrine 2.5% Topical

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

    Other intervention

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

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

    Other intervention

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

    Other intervention

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

Treatment groups

1,120 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: DA-001 TopicalExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Group C: Phenylephrine TopicalExperimental treatment 1 intervention
Group D: DA-001 Topical + DA-005 Oral (HIF-1α supplement)Experimental treatment 1 intervention
Group E: DA-010 - Oral Phenylephrine 20 mg + DA-005 Oral (HIF-1α supplement)Experimental treatment 1 intervention
Group F: Phenylephrine Topical 0.25% + Intact Pro TopicalExperimental treatment 1 intervention
Group G: Phenylephrine + Intact Pro + DA-005 Oral (HIF-1α supplement)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Mean Change in Hair Shedding

Number of hairs shedding during brushing at target area

Time frame
Minutes [0,5]

Secondary outcomes

1

Mean Change in Hair Shedding

Number of hairs shedding during brushing at target area

Time frame
Week [0, 4, 12, 24]
2

Mean Change in Target Area Hair Count (TAHC)

Number of hairs in a 1-cm² target scalp area

Time frame
Week [0, 4, 12, 24]

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Applied Biology, Inc.

Lead sponsor

Follea International Limited

Collaborator

Daniel Alain, Inc.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: