Trial · NCT03004469
Study to Evaluate the Efficacy and Safety of P-3074 Topical Solution in the Treatment of Androgenetic Alopecia
NCT03004469, Phase 3, Completed, Polichem S.A.; results first posted 2019-04-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate the Efficacy and Safety of P-3074 Topical Solution in the Treatment of Androgenetic Alopecia. Trials, record NCT03004469. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03004469
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Efficacy and Safety of P-3074 Topical Solution in the Treatment of Androgenetic Alopecia
- NCT number
- NCT03004469
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 458 participants, actual
- Lead sponsor
- Polichem S.A.
- Conditions
- Alopecia, Androgenetic
- Interventions
- P-3074, Finasteride, P-3074 Vehicle, Finasteride Placebo
- First posted
- 2016-12-28
- Last updated
- 2019-06-20
- Results first posted
- 2019-04-19
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Adjusted Mean Change From Baseline in Hair Growth Assessed by Target Area Hair Count (TAHC) in the Vertex at Week 24 | Baseline and Week 24 | The change from baseline in the TAHC within a 1 cm\^2 (square centimeter) of baldness area at Week 24, were assessed by macro photographic techniques analysis. The Investigator selected a target area in the anterior leading edge of the vertex thinning area. A small dot tattoo was placed in the center of the circle of the clipped hairs. Using the tattoo as a reference point, the circular area was photographed and a 1 cm\^2 circular area within the target area was analysed. Change is the adjusted mean of Week 24 minus baseline.The analysis uses a covariance pattern model adjusted for treatment group, center, visit and treatment-by-visit interaction as fixed effects and baseline hair count as a covariate with an unstructured covariance structure. |
| Secondary | Adjusted Mean Change From Baseline in Hair Growth Assessed by TAHC in the Vertex at Week 12 | Baseline and Week 12 | The change from baseline in the TAHC within a 1 cm\^2 of baldness area at Week 12, were assessed by macro photographic techniques analysis. The Investigator selected a target area in the anterior leading edge of the vertex thinning area. A small dot tattoo was placed in the center of the circle of the clipped hairs. Using the tattoo as a reference point, the circular area was photographed and a 1 cm\^2 circular area within the target area was analysed. Change is the adjusted mean of Week 24 minus baseline.The analysis uses a covariance pattern model adjusted for treatment group, center, visit and treatment-by-visit interaction as fixed effects and baseline hair count as a covariate with an unstructured covariance structure. |
| Secondary | Adjusted Mean Change From Baseline in Target Area Hair Width (TAHW) in the Vertex at Weeks 12 and 24 | Baseline, Week 12 and Week 24 | The change from baseline in the TAHW within a 1 cm\^2 of baldness area at Weeks 12 and 24, were assessed by macro photographic techniques analysis. The Investigator selected a target area in the anterior leading edge of the vertex thinning area. A small dot tattoo was placed in the center of the circle of the clipped hairs. Using the tattoo as a reference point, the circular area was photographed and a 1 cm\^2 circular area within the target area was analysed. Change is the adjusted mean of Weeks 12 and 24 minus baseline, respectively.The analysis uses a covariance pattern model adjusted for treatment group, center, visit and treatment-by-visit interaction as fixed effects and baseline hair count as a covariate with an unstructured covariance structure. |
| Secondary | Adjusted Mean Overall Male Hair Growth Questionnaire (MHGQ) Score as Assessed by the Participant at Weeks 12 and 24 | Week 12 and Week 24 | Participants assessed their scalp hair using a validated, self-administered MHGQ, which was given in their language. The self-administered MHGQ overall score assessed using the following 5-point scale: 1 = very satisfied, 2 = satisfied, 3 = neutral (neither satisfied nor dissatisfied), 4 = dissatisfied, 5 = very dissatisfied. A higher score indicated a worse outcome. The questionnaire was administered to eligible participants to subjectively measure their perception of hair growth. A higher score indicated a worse outcome. |
| Secondary | Adjusted Mean Change From Baseline in Participants Hair Growth/Loss Assessed for the Vertex by Investigator at Weeks 12 and 24 | Baseline, Week 12 and Week 24 | The local Investigator assessed change in hair growth from Baseline to Week 12 and from Baseline to Week 24, using a 7-point scale. The evaluation was done by the Investigator or designee, by comparing the global vertex view photograph obtained at baseline visit with the participants actual scalp at 12 and 24 weeks. For the purpose of assessment of changes in hair growth by Investigators screening visits (where global photos were taken) were used as Baseline. The change from Baseline in hair growth was assessed using the following 7-point scale: -3 = greatly decreased, -2 = moderately decreased, -1 = slightly decreased, 0 = no change, +1 = slightly increased, +2 = moderately increased, +3 = greatly increased. The analysis uses a covariance pattern model adjusted for treatment group, center, visit and treatment-by-visit interaction as fixed effects with an unstructured covariance structure. |
| Secondary | Adjusted Mean Change From Baseline in Participants Hair Growth/Loss at Weeks 12 and 24, Assessed for the Vertex by Blind Assessor | Baseline, Week 12 and Week 24 | An independent blinded assessor was responsible for evaluating, under blinded conditions, the screening global photographs of the target area for all participants. They evaluated the eligibility of each participants according to the clinical inclusion criteria. The independent blinded assessor assessed the change of the hair growth from Baseline to Week 12 and from Baseline to Week 24, using a 7-point scale: -3 = greatly decreased, -2 = moderately decreased, -1 = slightly decreased, 0 = no change, +1 = slightly increased, +2 = moderately increased, +3 = greatly increased. This assessment was performed by comparing the global photographs obtained at screening visit with those subsequently obtained at Weeks 12 and 24. The analysis uses a covariance pattern model adjusted for treatment group, center, visit and treatment-by-visit interaction as fixed effects with an unstructured covariance structure. |
| Secondary | Adjusted Mean International Index of Erectile Function (IIEF-2) Scores at Weeks 4, 8, 12 and 24 | Weeks 4, 8, 12 and 24 | The 15-question IIEF-2 Questionnaire (Sexual Function Questionnaire) was used to evaluate any changes in sexual function and activity, at Weeks 4, 8, 12 and 24. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction. Erectile function domain has 6 questions with the score for domain range from 0-30. Orgasmic function domain has 2 questions with the score for domain range from 0-10. , Sexual desire function domain has 2 questions with the score for domain range from 0-10. Intercourse satisfaction function domain has 3 questions with the score for domain range from 0-15. Overall Satisfaction domain has 2 questions with the score for domain range from 0-10. A higher score indicated a worse outcome in that domain. |
| Secondary | Local Tolerability as Assessed by Incidence Rate of Skin Irritation Event Via Severity Score for Skin Irritation Scale | Baseline to Week 24 | Local tolerability at the application site was assessed to rate the severity of any skin irritation. The Investigator used the Severity score for skin Irritation scale to assess local tolerability. The dermal response and other effects indicative irritation responses were recorded at time of examination. Anything other than "No evidence of irritation" under Dermal Response was considered as a Dermal Response Skin Irritation event. Anything other than "No other effects" under Other Effects was considered as an Other Effects of Skin Irritation event. The event incidence rate is calculated as the number of events interest divided by total personal time in years. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs | From the start of IMP up to 28 weeks | An Adverse event is defined as any untoward medical occurrence in a participants or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. A serious AE was an AE that results in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect and medically significant event. The Treatment Emergent Adverse Events (TEAEs) is defined as all AEs occurring on or after the first dose of the IMP. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Adjusted Mean Change From Baseline in Hair Growth Assessed by Target Area Hair Count (TAHC) in the Vertex at Week 24 | Baseline and Week 24 | Intent-to-Treat (ITT) Population included all participants who had measurements both at baseline and on treatment: i.e. participants who had measurements in regards to hair count both at baseline and on treatment. | Hairs | MEAN |
| SECONDARY | Adjusted Mean Change From Baseline in Hair Growth Assessed by TAHC in the Vertex at Week 12 | Baseline and Week 12 | ITT Population included all participants who had measurements both at baseline and on treatment: i.e. participants who had measurements in regards to hair count both at baseline and on treatment. | Hairs | MEAN |
| SECONDARY | Adjusted Mean Change From Baseline in Target Area Hair Width (TAHW) in the Vertex at Weeks 12 and 24 | Baseline, Week 12 and Week 24 | ITT Population included all participants who had measurements both at baseline and on treatment: i.e. participants who had measurements in regards to hair count both at baseline and on treatment. | Micrometer | MEAN |
| SECONDARY | Adjusted Mean Overall Male Hair Growth Questionnaire (MHGQ) Score as Assessed by the Participant at Weeks 12 and 24 | Week 12 and Week 24 | ITT Population included all participants who had measurements both at baseline and on treatment: i.e. participants who had measurements in regards to hair count both at baseline and on treatment. | score on a scale | MEAN |
| SECONDARY | Adjusted Mean Change From Baseline in Participants Hair Growth/Loss Assessed for the Vertex by Investigator at Weeks 12 and 24 | Baseline, Week 12 and Week 24 | ITT Population included all participants who had measurements both at baseline and on treatment: i.e. participants who had measurements in regards to hair count both at baseline and on treatment. | score on a scale | MEAN |
| SECONDARY | Adjusted Mean Change From Baseline in Participants Hair Growth/Loss at Weeks 12 and 24, Assessed for the Vertex by Blind Assessor | Baseline, Week 12 and Week 24 | ITT Population included all participants who had measurements both at baseline and on treatment: i.e. participants who had measurements in regards to hair count both at baseline and on treatment. | score on a scale | MEAN |
| SECONDARY | Adjusted Mean International Index of Erectile Function (IIEF-2) Scores at Weeks 4, 8, 12 and 24 | Weeks 4, 8, 12 and 24 | ITT Population included all participants who had measurements both at baseline and on treatment: i.e. participants who had measurements in regards to hair count both at baseline and on treatment. | score on a scale | MEAN |
| SECONDARY | Local Tolerability as Assessed by Incidence Rate of Skin Irritation Event Via Severity Score for Skin Irritation Scale | Baseline to Week 24 | Safety Population includes all randomized participants who received at least one application of the IMP. | Events per personal years | NUMBER |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs | From the start of IMP up to 28 weeks | Safety Population includes all randomized participants who received at least one application of the IMP. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group102
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Adjusted Mean Change From Baseline in Hair Growth Assessed by Target Area Hair Count (TAHC) in the Vertex at Week 24 | P-3074 + Finasteride Placebo | 20.2 | Standard Deviation 2.88 | Hairs | |
| Adjusted Mean Change From Baseline in Hair Growth Assessed by Target Area Hair Count (TAHC) in the Vertex at Week 24 | P-3074 Vehicle + Finasteride Placebo | 6.7 | Standard Deviation 3.01 | Hairs | |
| Adjusted Mean Change From Baseline in Hair Growth Assessed by Target Area Hair Count (TAHC) in the Vertex at Week 24 | Oral Finasteride + P-3074 Vehicle | 21.1 | Standard Deviation 3.90 | Hairs | |
| Adjusted Mean Change From Baseline in Hair Growth Assessed by TAHC in the Vertex at Week 12 | P-3074 + Finasteride Placebo | 20.4 | Standard Deviation 2.41 | Hairs | |
| Adjusted Mean Change From Baseline in Hair Growth Assessed by TAHC in the Vertex at Week 12 | P-3074 Vehicle + Finasteride Placebo | 7.6 | Standard Deviation 2.46 | Hairs | |
| Adjusted Mean Change From Baseline in Hair Growth Assessed by TAHC in the Vertex at Week 12 | Oral Finasteride + P-3074 Vehicle | 22.5 | Standard Deviation 3.31 | Hairs | |
| Adjusted Mean Change From Baseline in Target Area Hair Width (TAHW) in the Vertex at Weeks 12 and 24 | P-3074 + Finasteride Placebo | Week 12 | -1.1231 | Standard Deviation 0.30653 | Micrometer |
| Adjusted Mean Change From Baseline in Target Area Hair Width (TAHW) in the Vertex at Weeks 12 and 24 | P-3074 Vehicle + Finasteride Placebo | Week 12 | -0.7207 | Standard Deviation 0.31033 | Micrometer |
| Adjusted Mean Change From Baseline in Target Area Hair Width (TAHW) in the Vertex at Weeks 12 and 24 | Oral Finasteride + P-3074 Vehicle | Week 12 | -0.6938 | Standard Deviation 0.41951 | Micrometer |
| Adjusted Mean Change From Baseline in Target Area Hair Width (TAHW) in the Vertex at Weeks 12 and 24 | P-3074 + Finasteride Placebo | Week 24 | -0.8052 | Standard Deviation 0.35151 | Micrometer |
1 to 10 of 102Source ClinicalTrials.gov
See all 102 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | P-3074 + Finasteride Placebo | 189 | |
| Overall Study | STARTED | P-3074 Vehicle + Finasteride Placebo | 184 | |
| Overall Study | STARTED | Oral Finasteride + P-3074 Vehicle | 85 | |
| Overall Study | COMPLETED | P-3074 + Finasteride Placebo | 128 | |
| Overall Study | COMPLETED | P-3074 Vehicle + Finasteride Placebo | 135 | |
| Overall Study | COMPLETED | Oral Finasteride + P-3074 Vehicle | 60 | |
| Overall Study | NOT COMPLETED | P-3074 + Finasteride Placebo | 61 | |
| Overall Study | NOT COMPLETED | P-3074 Vehicle + Finasteride Placebo | 49 | |
| Overall Study | NOT COMPLETED | Oral Finasteride + P-3074 Vehicle | 25 |
Source ClinicalTrials.gov
Adverse events510
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Lymphadenopathy | Blood and lymphatic system disorders | P-3074 + Finasteride Placebo | 1 | 181 | 1 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | P-3074 Vehicle + Finasteride Placebo | 0 | 181 | 0 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Oral Finasteride + P-3074 Vehicle | 1 | 84 | 1 |
| other | Sinus arrhythmia | Cardiac disorders | P-3074 + Finasteride Placebo | 0 | 181 | 0 |
| other | Sinus arrhythmia | Cardiac disorders | P-3074 Vehicle + Finasteride Placebo | 1 | 181 | 1 |
| other | Sinus arrhythmia | Cardiac disorders | Oral Finasteride + P-3074 Vehicle | 0 | 84 | 0 |
| other | Tachycardia | Cardiac disorders | P-3074 + Finasteride Placebo | 1 | 181 | 1 |
| other | Tachycardia | Cardiac disorders | P-3074 Vehicle + Finasteride Placebo | 0 | 181 | 0 |
| other | Tachycardia | Cardiac disorders | Oral Finasteride + P-3074 Vehicle | 0 | 84 | 0 |
| other | Vertigo | Ear and labyrinth disorders | P-3074 + Finasteride Placebo | 1 | 181 | 1 |
1 to 10 of 510Source ClinicalTrials.gov
See all 510 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | P-3074 + Finasteride Placebo | 0 | 181 |
| Total, all-cause mortality | P-3074 Vehicle + Finasteride Placebo | 0 | 181 |
| Total, all-cause mortality | Oral Finasteride + P-3074 Vehicle | 0 | 84 |
| Total, other adverse events | P-3074 + Finasteride Placebo | 74 | 181 |
| Total, other adverse events | P-3074 Vehicle + Finasteride Placebo | 73 | 181 |
| Total, other adverse events | Oral Finasteride + P-3074 Vehicle | 40 | 84 |
| Total, serious adverse events | P-3074 + Finasteride Placebo | 4 | 181 |
| Total, serious adverse events | P-3074 Vehicle + Finasteride Placebo | 5 | 181 |
| Total, serious adverse events | Oral Finasteride + P-3074 Vehicle | 1 | 84 |
Source ClinicalTrials.gov
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.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license 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/NCT03004469
GET https://conductscience.org/api/trials/v1/NCT03004469/results?page=2