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This study will evaluate the safety and efficacy of PDFE-2304 compared with Minoxidil 5% in men with androgenic alopecia (AGA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PDFE-2304 Topical Solution | Experimental | Approximately one mL dose applied onto a pre-specified scalp area twice daily for 16 weeks. |
|
| Minoxidil 5% Topical Solution | Active Comparator | Approximately one mL dose applied onto a pre-specified scalp area twice daily for 16 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minoxidil 5% Topical Solution | Drug | Approximately one mL dose applied onto a pre-specified scalp area twice daily for 16 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline, Week 16 (Day 112) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria -
Exclusion Criteria -
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Koppal Institute of Medical Sciences | Koppal | Karnataka | 583231 | India |
Legal and Regulatory Barriers
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Parallel-group (2:1)
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Triple (Participant, Investigator, Outcomes Assessor)
| PDFE-2304 Topical Solution | Drug | Approximately one mL dose applied onto a pre-specified scalp area twice daily for 16 weeks. |
|
| 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. | 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). | 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). | 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. | Week 16 (Day 112) |
| Adverse Events | Any undesirable experience associated with the treatment or the comparator in a study participant. | Baseline, Week 16 (Day 112) |
| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008914 | Minoxidil |
| D012996 | Solutions |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
| D004364 | Pharmaceutical Preparations |
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