Androgenetic AlopeciaPhase 3NCT06501924
Clinical Study of DA-002 and DA-005 As a Treatment for Hair Loss
A Phase 3 study testing DA-005, Topical minoxidil 5% and DA-002 in people with Androgenetic Alopecia and Female Pattern Baldness, run by Applied Biology, Inc..
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Androgenetic Alopecia, Female Pattern Baldness, Male Pattern Baldness
- What is being tested?
- DA-005, Topical minoxidil 5% and DA-002
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 516 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2025to 12 Dec 2025
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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).
Read the detailed description
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).
- Being tested
- DA-005, Topical minoxidil 5%, DA-002, Placebo Oral Tablet, Placebo Topical Solution
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DA-005Dietary supplement
Also called Daniel Alain Botanical Supplement Treatment for Hair Loss
Oral Botanical Supplement HIF-1a inhibitor
Topical minoxidil 5%Drug
Topical minoxidil 5%
DA-002Drug
Topical Alpha 1 Agonist (GRAS)
Placebo Oral TabletDietary supplement
Placebo Oral Tablet
Placebo Topical SolutionOther
Placebo Topical Solution
| Study group | Role | What they receive |
|---|---|---|
| DA-005 | Experimental | Oral Botanical Supplement HIF-1a inhibitor Receives: Dietary Supplement: DA-005; Other: Placebo Topical Solution |
| Topical Minoxidil 5% | Active comparator | Topical Minoxidil 5% Receives: Drug: Topical minoxidil 5%; Dietary Supplement: Placebo Oral Tablet |
| DA-002 | Experimental | Topical Alpha 1 Agonist Receives: Drug: DA-002; Dietary Supplement: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Area Hair Counts
Target Area Hair Counts
Measured: Week [0,12]
Target Area Hair Counts
Target Area Hair Counts
Measured: Week [0,24]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start15 Jan 2025 (estimated)
- Primary completion17 Oct 2025 (estimated)
- Study completion12 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenetic AlopeciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 516 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Applied Biology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Follea International Limited, Daniel Alain, Inc.
- Responsible party
- Sponsor
- Investigators
- Andy Goren, MD, Study director, University of Rome G. Marconi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06501924
- Sponsor's protocol ID
- DA-005
- Status last verified
- Dec 2024
- First submitted
- 8 Jul 2024
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of DA-002 and DA-005 As a Treatment for Hair Loss
- ClinicalTrials.gov ID
- NCT06501924
- Acronym / sponsor ID
- DA-005
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 516 participants (estimated)
- Lead sponsor
- Applied Biology, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Follea International Limited, Daniel Alain, Inc.
- Study start
- 15 Jan 2025 (estimated)
- Primary completion
- 17 Oct 2025 (estimated)
- Study completion
- 12 Dec 2025 (estimated)
- First posted
- 15 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DA-005 | Experimental | Dietary Supplement: DA-005, Other: Placebo Topical SolutionOral Botanical Supplement HIF-1a inhibitor |
| Topical Minoxidil 5% | Active comparator | Drug: Topical minoxidil 5%, Dietary Supplement: Placebo Oral TabletTopical Minoxidil 5% |
| DA-002 | Experimental | Drug: DA-002, Dietary Supplement: Placebo Oral TabletTopical Alpha 1 Agonist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DA-005Also: Daniel Alain Botanical Supplement Treatment for Hair LossOral Botanical Supplement HIF-1a inhibitor | Dietary supplement | DA-005 |
| Topical minoxidil 5%Topical minoxidil 5% | Drug | Topical Minoxidil 5% |
| DA-002Topical Alpha 1 Agonist (GRAS) | Drug | DA-002 |
| Placebo Oral TabletPlacebo Oral Tablet | Dietary supplement | DA-002, Topical Minoxidil 5% |
| Placebo Topical SolutionPlacebo Topical Solution | Other | DA-005 |
Primary outcome
Target Area Hair Counts
Time frame: Week [0,12]
Target Area Hair Counts
Target Area Hair Counts
Time frame: Week [0,24]
Target Area Hair Counts
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
- Daniel Alain, Inc. - Updated Study InformationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andy Goren, MD study director
University of Rome G. Marconi
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DA-005, Topical minoxidil 5% and DA-002 in people with Androgenetic Alopecia and Female Pattern Baldness, run by Applied Biology, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andy Goren, MD (16507040850, clincalstudies@appliedbiology.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target Area Hair Counts (time frame: Week [0,12]). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2024.