Androgenetic AlopeciaPhase 3NCT06484881
Clinical Study of Probiotic Treatment for Androgenetic Alopecia
A Phase 3 study testing Daniel Alain Probiotic Treatment for Androgenetic Alopecia and Topical minoxidil 5% 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 efficacy of DA-001 as an oral supplement for treatment of female pattern hair loss. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Androgenetic Alopecia, Female Pattern Baldness
- What is being tested?
- Daniel Alain Probiotic Treatment for Androgenetic Alopecia and Topical minoxidil 5%
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2024to 10 Oct 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females Age 18 or older
- Diagnosed with female pattern hair loss
- 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-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
About this study
The primary objective of the study is to assess the efficacy of DA-001 as an oral supplement for treatment of female pattern hair loss.
Read the detailed description
DA-001 is a botanical supplement demonstrated natural ingredients known to exert anti-androgen effects. The ingredients were tested in-vitro and have demonstrated the anti-androgen effect. This study aims to compare DA-001 to topical minoxidil in the treatment of female pattern hair loss (also known as androgenetic alopecia).
- Conditions
- Androgenetic Alopecia, Female Pattern Baldness
- Being tested
- Daniel Alain Probiotic Treatment for Androgenetic Alopecia, Topical minoxidil 5%
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daniel Alain Probiotic Treatment for Androgenetic AlopeciaDietary supplement
Probiotic
Topical minoxidil 5%Drug
Topical minoxidil 5%
| Study group | Role | What they receive |
|---|---|---|
| Topical Minoxidil 5% + Multivitamin Oral Supplement | Active comparator | Topical Minoxidil 5% + Multivitamin Oral Supplement Receives: Drug: Topical minoxidil 5% |
| Placebo Spray + Daniel Alain Probiotic Treatment for Androgenetic Alopecia | Experimental | Placebo Spray + Daniel Alain Probiotic Treatment for Androgenetic Alopecia Receives: Dietary Supplement: Daniel Alain Probiotic Treatment for Androgenetic Alopecia |
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]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start15 Sep 2024
- Primary completion10 Oct 2024
- Study completion10 Oct 2024
Why it stopped: Concern about formulation patent
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Applied Biology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Follea International Limited
- Responsible party
- Principal investigator, Monica Naegle, Applied Biology, Inc.
- Investigators
- Andy Goren, MD, Study director, University of Rome G. Marconi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06484881
- Sponsor's protocol ID
- DA-001
- Status last verified
- Jun 2024
- First submitted
- 26 Jun 2024
- Last updated
- 15 Oct 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 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Probiotic Treatment for Androgenetic Alopecia
- ClinicalTrials.gov ID
- NCT06484881
- Acronym / sponsor ID
- DA-001
- Conditions
- Androgenetic Alopecia, Female Pattern Baldness
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Concern about formulation patent
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Applied Biology, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Follea International Limited
- Study start
- 15 Sep 2024 (actual)
- Primary completion
- 10 Oct 2024 (actual)
- Study completion
- 10 Oct 2024 (actual)
- First posted
- 3 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 efficacy of DA-001 as an oral supplement for treatment of female pattern hair loss.
Detailed description
DA-001 is a botanical supplement demonstrated natural ingredients known to exert anti-androgen effects. The ingredients were tested in-vitro and have demonstrated the anti-androgen effect. This study aims to compare DA-001 to topical minoxidil in the treatment of female pattern 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
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical Minoxidil 5% + Multivitamin Oral Supplement | Active comparator | Drug: Topical minoxidil 5%Topical Minoxidil 5% + Multivitamin Oral Supplement |
| Placebo Spray + Daniel Alain Probiotic Treatment for Androgenetic Alopecia | Experimental | Dietary Supplement: Daniel Alain Probiotic Treatment for Androgenetic AlopeciaPlacebo Spray + Daniel Alain Probiotic Treatment for Androgenetic Alopecia |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Females Age 18 or older
- Diagnosed with female pattern hair loss
- 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-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
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 |
|---|---|---|
| Daniel Alain Probiotic Treatment for Androgenetic AlopeciaProbiotic | Dietary supplement | Placebo Spray + Daniel Alain Probiotic Treatment for Androgenetic Alopecia |
| Topical minoxidil 5%Topical minoxidil 5% | Drug | Topical Minoxidil 5% + Multivitamin Oral Supplement |
Primary outcome
Target Area Hair Counts
Time frame: Week [0,12]
Target Area Hair Counts
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Androgenetic Alopecia
Not yet recruitingPhase 2
Phase 2 Efficacy and Safety of PP405 in Adult Females With Androgenetic Alopecia
Androgenetic Alopecia
Not yet recruitingPhase 3
Phase 3 Study to Evaluate the Efficacy and Safety of Oral Minoxidil (N1087) in Men With Androgenetic Alopecia.
Androgenetic Alopecia, Androgenetic Alopecia (AGA)
Not yet recruiting
Study to Evaluate Xtressé Gummy Supplement in Women With Thinning Hair
Androgenetic Alopecia
Not yet recruitingEarly Phase 1
Evaluating the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Androgenic Alopecia
Androgenic Alopecia
Not yet recruitingPhase 3
Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of N1087 in Participants With Female Pattern Hair Loss (MINORA-WOMEN)
Female Pattern Hair Loss, Female Pattern Hair Loss, Androgenic Alopecia
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. This study is not recruiting at the moment.
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 Daniel Alain Probiotic Treatment for Androgenetic Alopecia and Topical minoxidil 5% 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: withdrawn, as of the sponsor's last update on 15 Oct 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target Area Hair Counts (time frame: Week [0,12]). 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 15 Oct 2024.