Alopecia, AndrogeneticPhase 2NEOPILI-2ANCT07011485
A Safety and Efficacy Study of PDFE-2304 Topical Solution for the Treatment of Androgenic Alopecia.
A Phase 2 study testing Minoxidil 5% Topical Solution and PDFE-2304 Topical Solution in people with Alopecia, Androgenetic and Baldness, run by PDFE Pharma Innovations FZCO at 1 site in India.
Trial summary
This study will evaluate the safety and efficacy of PDFE-2304 compared with Minoxidil 5% in men with androgenic alopecia (AGA). Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Alopecia, Androgenetic, Baldness, Androgenetic Alopecia (AGA)
- What is being tested?
- Minoxidil 5% Topical Solution and PDFE-2304 Topical Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteIndia
- Study dates
- 14 May 2025to 17 Sep 2025
- Phase
- Phase 2
- 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 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Men who have a presentation of androgenetic alopecia (Norwood II - V).
- Age between 18 to 60 years of age (both inclusive).
- Have no abnormal findings during physical examination.
- Able to comply with the study procedures in the opinion of the PI/CI.
- Able to give written consent for participation in the study.
Who cannot join
- Known hypersensitivity or idiosyncratic reaction to the API´s.
- Clinical diagnosis of non-AGA forms of alopecia.
- History of hair transplants.
- Subject having dyed or bleached hair 12 months prior to study start.
- Use of any topical product in the target region in the last 6 months.
- A medical history of receiving chemotherapy/cytotoxic agents.
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- Uncontrolled hypertension.
- Any dermatological disorders (eczema, psoriasis, sun damage, skin cancer).
- Hormonal diseases such as thyroid disorders or diabetes.
- Liver and kidney disease.
- Smokers.
- Drug or alcohol abuse within 12 months.
- No written consent.
- The receipt of an investigational product or participation in a drug research study within a period of 90 days prior to the first dose of study drug.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Triple-Blind, Randomized, Efficacy and Tolerability Comparison Study of PDFE-2304 Topical Solution Versus Minoxidil 5% Topical Solution for the Treatment of Androgenic Alopecia (AGA).
This study will evaluate the safety and efficacy of PDFE-2304 compared with Minoxidil 5% in men with androgenic alopecia (AGA).
- Being tested
- Minoxidil 5% Topical Solution, PDFE-2304 Topical Solution
- Keywords
- Double Blind, Randomized, Efficacy, Tolerability, Comparison, Treatment
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minoxidil 5% Topical SolutionDrug
Approximately one mL dose applied onto a pre-specified scalp area twice daily for 16 weeks.
PDFE-2304 Topical SolutionDrug
Approximately one mL dose applied onto a pre-specified scalp area twice daily for 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| PDFE-2304 Topical Solution | Experimental | Approximately one mL dose applied onto a pre-specified scalp area twice daily for 16 weeks. Receives: Drug: PDFE-2304 Topical Solution |
| Minoxidil 5% Topical Solution | Active comparator | Approximately one mL dose applied onto a pre-specified scalp area twice daily for 16 weeks. Receives: Drug: Minoxidil 5% Topical Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Target Area Hair Count (TAHC)
TAHC is measured using digital imaging analysis and is reported in terminal hairs/centimeters squared (cm^2). A positive change from Baseline indicates improvement (increase in the number of terminal hairs) and a negative change from Baseline indicates worsening (decrease in the number of terminal hairs).
Measured: Baseline, Week 16 (Day 112)
Secondary outcomes (6)
Percentage of Participants in Each Response Category of the Subject Self-Assessment in Alopecia (SSA) Score
The SSA score measures scalp hair growth. Using a 7-point scale, participants will answer the Question: "Since the start of the study, the amount of my hair has?": Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category will be presented.
Measured: Week 16 (Day 112)
Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score
The investigator will compare the participant's scalp hair growth at Week 16 (Day 112) to a photograph of the scalp taken at Baseline and using the 7-point IGA score, the investigator will answer the question: "Since the start of the study, the amount of the subject's hair has?": Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented.
Measured: Week 16 (Day 112)
Change From Baseline in Target Area Hair Width (TAHW)
Digital imaging analysis will be used to measure TAHW in millimeters/centimeters squared (mm/cm^2). The diameters of all terminal hairs (individual hairs ≥ 30 microns in width) in the target area will be summed and reported together. A positive change from Baseline indicates improvement (increase in the diameter of terminal hairs) and a negative change from Baseline indicates worsening (decrease in the diameter of terminal hairs).
Measured: Baseline, Week 16 (Day 112)
Change From Baseline in Target Area Hair Darkness (TAHD)
Digital imaging analysis will be used to measure TAHD. The darkness of all terminal hairs (individual hairs ≥ 30 microns in width) in the target area will be summed and divided by total number of terminal hairs in the same target area and will be reported as intensity units. A positive change from Baseline indicates improvement (increase in the darkness of terminal hairs) and a negative change from Baseline indicates worsening (decrease in the darkness of terminal hairs).
Measured: Baseline, Week 16 (Day 112)
Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score
At the completion of the study, 3 independent dermatologists using the 7-point GPR score compared photographs of the participant's scalp hair growth at Week 16 (Day 112) to Baseline will answer the question: "Compared with the baseline image, the amount of the subject's hair has?": Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category will be presented.
Measured: Week 16 (Day 112)
Adverse Events
Any undesirable experience associated with the treatment or the comparator in a study participant.
Measured: Baseline, Week 16 (Day 112)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start14 May 2025
- Primary completion14 Aug 2025 (estimated)
- Study completion17 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alopecia, AndrogeneticStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel-group (2:1)
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PDFE Pharma Innovations FZCO
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07011485
- Sponsor's protocol ID
- PDFE-CL-24-001
- Acronym
- NEOPILI-2A
- Status last verified
- May 2025
- First submitted
- 14 May 2025
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Legal and Regulatory Barriers
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Triple-Blind, Randomized, Efficacy and Tolerability Comparison Study of PDFE-2304 Topical Solution Versus Minoxidil 5% Topical Solution for the Treatment of Androgenic Alopecia (AGA).
- ClinicalTrials.gov ID
- NCT07011485
- Acronym / sponsor ID
- NEOPILI-2A / PDFE-CL-24-001
- Keywords
- Double Blind, Randomized, Efficacy, Tolerability, Comparison, Treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- PDFE Pharma Innovations FZCOIndustry (pharma, biotech, devices)
- Study start
- 14 May 2025 (actual)
- Primary completion
- 14 Aug 2025 (estimated)
- Study completion
- 17 Sep 2025 (estimated)
- First posted
- 8 Jun 2025 (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.
This study will evaluate the safety and efficacy of PDFE-2304 compared with Minoxidil 5% in men with androgenic alopecia (AGA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel-group (2:1)
| Arm | Type | Receives |
|---|---|---|
| PDFE-2304 Topical Solution | Experimental | Drug: PDFE-2304 Topical SolutionApproximately one mL dose applied onto a pre-specified scalp area twice daily for 16 weeks. |
| Minoxidil 5% Topical Solution | Active comparator | Drug: Minoxidil 5% Topical SolutionApproximately one mL dose applied onto a pre-specified scalp area twice daily for 16 weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Men who have a presentation of androgenetic alopecia (Norwood II - V).
- Age between 18 to 60 years of age (both inclusive).
- Have no abnormal findings during physical examination.
- Able to comply with the study procedures in the opinion of the PI/CI.
- Able to give written consent for participation in the study.
Key exclusion criteria (14 listed)
- Known hypersensitivity or idiosyncratic reaction to the API´s.
- Clinical diagnosis of non-AGA forms of alopecia.
- History of hair transplants.
- Subject having dyed or bleached hair 12 months prior to study start.
- Use of any topical product in the target region in the last 6 months.
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 |
|---|---|---|
| Minoxidil 5% Topical SolutionApproximately one mL dose applied onto a pre-specified scalp area twice daily for 16 weeks. | Drug | Minoxidil 5% Topical Solution |
| PDFE-2304 Topical SolutionApproximately one mL dose applied onto a pre-specified scalp area twice daily for 16 weeks. | Drug | PDFE-2304 Topical Solution |
Primary outcome
Change From Baseline in Target Area Hair Count (TAHC)
Time frame: Baseline, Week 16 (Day 112)
TAHC is measured using digital imaging analysis and is reported in terminal hairs/centimeters squared (cm^2). A positive change from Baseline indicates improvement (increase in the number of terminal hairs) and a negative change from Baseline indicates worsening (decrease in the number of terminal hairs).
6 secondary outcomes
Percentage of Participants in Each Response Category of the Subject Self-Assessment in Alopecia (SSA) Score
Time frame: Week 16 (Day 112)
Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score
Time frame: Week 16 (Day 112)
Change From Baseline in Target Area Hair Width (TAHW)
Time frame: Baseline, Week 16 (Day 112)
Change From Baseline in Target Area Hair Darkness (TAHD)
Time frame: Baseline, Week 16 (Day 112)
Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score
Time frame: Week 16 (Day 112)
Adverse Events
Time frame: Baseline, Week 16 (Day 112)
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 8 Jun 2025.
- Individual participant dataSharing planned: No. Legal and Regulatory Barriers
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Minoxidil 5% Topical Solution and PDFE-2304 Topical Solution in people with Alopecia, Androgenetic and Baldness, run by PDFE Pharma Innovations FZCO at 1 site in India.
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 14 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: under way, not looking for participants, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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?
Change From Baseline in Target Area Hair Count (TAHC) (time frame: Baseline, Week 16 (Day 112)). 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 8 Jun 2025.