Trial · NCT07011485
A Safety and Efficacy Study of PDFE-2304 Topical Solution for the Treatment of Androgenic Alopecia.
NCT07011485, Phase 2, Active not recruiting, PDFE Pharma Innovations FZCO
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. A Safety and Efficacy Study of PDFE-2304 Topical Solution for the Treatment of Androgenic Alopecia. Trials, record NCT07011485. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07011485
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Safety and Efficacy Study of PDFE-2304 Topical Solution for the Treatment of Androgenic Alopecia.
- NCT number
- NCT07011485
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 15 participants, estimated
- Lead sponsor
- PDFE Pharma Innovations FZCO
- Conditions
- Alopecia, Androgenetic, Baldness, Androgenetic Alopecia (AGA)
- Interventions
- Minoxidil 5% Topical Solution, PDFE-2304 Topical Solution
- First posted
- 2025-06-08
- Last updated
- 2025-06-08
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Target Area Hair Count (TAHC) | 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). |
| Secondary | Percentage of Participants in Each Response Category of the Subject Self-Assessment in Alopecia (SSA) Score | Week 16 (Day 112) | 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. |
| Secondary | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Week 16 (Day 112) | 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. |
| Secondary | Change From Baseline in Target Area Hair Width (TAHW) | Baseline, Week 16 (Day 112) | 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). |
| Secondary | Change From Baseline in Target Area Hair Darkness (TAHD) | Baseline, Week 16 (Day 112) | 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). |
| Secondary | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Week 16 (Day 112) | 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. |
| Secondary | Adverse Events | Baseline, Week 16 (Day 112) | Any undesirable experience associated with the treatment or the comparator in a study participant. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07011485
GET https://conductscience.org/api/trials/v1/NCT07011485/registered