Trial Outcomes & Findings for Study to Evaluate the Efficacy and Safety of P-3074 Topical Solution in the Treatment of Androgenetic Alopecia (NCT NCT03004469)

Last Updated: 2019-06-20

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

458 participants

Primary outcome timeframe

Baseline and Week 24

Results posted on

2019-06-20

Participant Flow

Study was conducted in 5 countries, in 52 sites and initiated on 02 Aug 2016 (First participant first visit) and the study got completed on 05 Mar 2018 (Last participant last visit).

A total of 632 participants were screened, with 458 participants being randomized.

Participant milestones

Participant milestones
Measure	P-3074 + Finasteride Placebo Participants received topical application of P-3074 contained finasteride 0.25% in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1-milligram (mg) tablet orally once daily for 24 weeks.	P-3074 Vehicle + Finasteride Placebo Participants received topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.	Oral Finasteride + P-3074 Vehicle Participants received finasteride 1 mg tablet orally once daily followed by topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) for 24 weeks.
Overall Study STARTED	189	184	85
Overall Study COMPLETED	128	135	60
Overall Study NOT COMPLETED	61	49	25

Reasons for withdrawal

Reasons for withdrawal
Measure	P-3074 + Finasteride Placebo Participants received topical application of P-3074 contained finasteride 0.25% in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1-milligram (mg) tablet orally once daily for 24 weeks.	P-3074 Vehicle + Finasteride Placebo Participants received topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.	Oral Finasteride + P-3074 Vehicle Participants received finasteride 1 mg tablet orally once daily followed by topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) for 24 weeks.
Overall Study Adverse Event	6	4	6
Overall Study Lack of Efficacy	1	0	1
Overall Study Lost to Follow-up	23	14	6
Overall Study Non-Compliance with Study Drug	2	0	0
Overall Study Protocol Violation	0	0	1
Overall Study Withdrawal by Subject	29	27	10
Overall Study Other unspecified reason	0	4	1

Baseline Characteristics

Study to Evaluate the Efficacy and Safety of P-3074 Topical Solution in the Treatment of Androgenetic Alopecia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	P-3074 + Finasteride Placebo n=189 Participants Participants received topical application of P-3074 contained finasteride 0.25% in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1mg tablet orally once daily for 24 weeks	P-3074 Vehicle + Finasteride Placebo n=184 Participants Participants received topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.	Oral Finasteride + P-3074 Vehicle n=85 Participants Participants received finasteride 1 mg tablet orally once daily followed by topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) for the 24 weeks.	Total n=458 Participants Total of all reporting groups
Age, Continuous	31.7 years STANDARD_DEVIATION 5.4 • n=5 Participants	32.0 years STANDARD_DEVIATION 4.8 • n=7 Participants	31.9 years STANDARD_DEVIATION 5.6 • n=5 Participants	31.9 years STANDARD_DEVIATION 5.2 • n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Male	189 Participants n=5 Participants	184 Participants n=7 Participants	85 Participants n=5 Participants	458 Participants n=4 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Race/Ethnicity, Customized Black/African American	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Caucasian/White	187 Participants n=5 Participants	181 Participants n=7 Participants	83 Participants n=5 Participants	451 Participants n=4 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline and Week 24

Population: 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.

Outcome measures

Outcome measures
Measure	P-3074 + Finasteride Placebo n=105 Participants Participants received topical application of P-3074 contained finasteride 0.25% in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.	P-3074 Vehicle + Finasteride Placebo n=97 Participants Participants received topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.	Oral Finasteride + P-3074 Vehicle n=48 Participants Participants received finasteride 1 mg tablet orally once daily followed by topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) for the 24 weeks.
Adjusted Mean Change From Baseline in Hair Growth Assessed by Target Area Hair Count (TAHC) in the Vertex at Week 24	20.2 Hairs Standard Deviation 2.88	6.7 Hairs Standard Deviation 3.01	21.1 Hairs Standard Deviation 3.90

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: 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.

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.

Outcome measures

Outcome measures
Measure	P-3074 + Finasteride Placebo n=105 Participants Participants received topical application of P-3074 contained finasteride 0.25% in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.	P-3074 Vehicle + Finasteride Placebo n=97 Participants Participants received topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.	Oral Finasteride + P-3074 Vehicle n=48 Participants Participants received finasteride 1 mg tablet orally once daily followed by topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) for the 24 weeks.
Adjusted Mean Change From Baseline in Hair Growth Assessed by TAHC in the Vertex at Week 12	20.4 Hairs Standard Deviation 2.41	7.6 Hairs Standard Deviation 2.46	22.5 Hairs Standard Deviation 3.31

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	P-3074 + Finasteride Placebo n=105 Participants Participants received topical application of P-3074 contained finasteride 0.25% in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.	P-3074 Vehicle + Finasteride Placebo n=97 Participants Participants received topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.	Oral Finasteride + P-3074 Vehicle n=48 Participants Participants received finasteride 1 mg tablet orally once daily followed by topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) for the 24 weeks.
Adjusted Mean Change From Baseline in Target Area Hair Width (TAHW) in the Vertex at Weeks 12 and 24 Week 12	-1.1231 Micrometer Standard Deviation 0.30653	-0.7207 Micrometer Standard Deviation 0.31033	-0.6938 Micrometer Standard Deviation 0.41951
Adjusted Mean Change From Baseline in Target Area Hair Width (TAHW) in the Vertex at Weeks 12 and 24 Week 24	-0.8052 Micrometer Standard Deviation 0.35151	-1.5289 Micrometer Standard Deviation 0.36691	0.7163 Micrometer Standard Deviation 0.46679

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	P-3074 + Finasteride Placebo n=105 Participants Participants received topical application of P-3074 contained finasteride 0.25% in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.	P-3074 Vehicle + Finasteride Placebo n=97 Participants Participants received topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.	Oral Finasteride + P-3074 Vehicle n=48 Participants Participants received finasteride 1 mg tablet orally once daily followed by topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) for the 24 weeks.
Adjusted Mean Overall Male Hair Growth Questionnaire (MHGQ) Score as Assessed by the Participant at Weeks 12 and 24 Week 12	2.9 score on a scale Standard Error 0.08	3.0 score on a scale Standard Error 0.09	2.8 score on a scale Standard Error 0.12
Adjusted Mean Overall Male Hair Growth Questionnaire (MHGQ) Score as Assessed by the Participant at Weeks 12 and 24 Week 24	2.8 score on a scale Standard Error 0.09	3.0 score on a scale Standard Error 0.10	2.9 score on a scale Standard Error 0.13

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	P-3074 + Finasteride Placebo n=105 Participants Participants received topical application of P-3074 contained finasteride 0.25% in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.	P-3074 Vehicle + Finasteride Placebo n=97 Participants Participants received topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.	Oral Finasteride + P-3074 Vehicle n=48 Participants Participants received finasteride 1 mg tablet orally once daily followed by topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) for the 24 weeks.
Adjusted Mean Change From Baseline in Participants Hair Growth/Loss Assessed for the Vertex by Investigator at Weeks 12 and 24 Week 12	0.5 score on a scale Standard Error 0.10	0.4 score on a scale Standard Error 0.11	0.5 score on a scale Standard Error 0.15
Adjusted Mean Change From Baseline in Participants Hair Growth/Loss Assessed for the Vertex by Investigator at Weeks 12 and 24 Week 24	0.8 score on a scale Standard Error 0.09	0.3 score on a scale Standard Error 0.09	0.7 score on a scale Standard Error 12

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	P-3074 + Finasteride Placebo n=105 Participants Participants received topical application of P-3074 contained finasteride 0.25% in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.	P-3074 Vehicle + Finasteride Placebo n=97 Participants Participants received topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.	Oral Finasteride + P-3074 Vehicle n=48 Participants Participants received finasteride 1 mg tablet orally once daily followed by topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) for the 24 weeks.
Adjusted Mean Change From Baseline in Participants Hair Growth/Loss at Weeks 12 and 24, Assessed for the Vertex by Blind Assessor Week 12	0.0 score on a scale Standard Error 0.08	0.2 score on a scale Standard Error 0.08	0.2 score on a scale Standard Error 0.11
Adjusted Mean Change From Baseline in Participants Hair Growth/Loss at Weeks 12 and 24, Assessed for the Vertex by Blind Assessor Week 24	0.2 score on a scale Standard Error 0.09	0.1 score on a scale Standard Error 0.09	0.3 score on a scale Standard Error 0.12

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	P-3074 + Finasteride Placebo n=105 Participants Participants received topical application of P-3074 contained finasteride 0.25% in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.	P-3074 Vehicle + Finasteride Placebo n=97 Participants Participants received topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.	Oral Finasteride + P-3074 Vehicle n=48 Participants Participants received finasteride 1 mg tablet orally once daily followed by topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) for the 24 weeks.
Adjusted Mean International Index of Erectile Function (IIEF-2) Scores at Weeks 4, 8, 12 and 24 Erectile Function Score, Week 4	24.5 score on a scale Standard Error 0.76	26.2 score on a scale Standard Error 0.79	23.5 score on a scale Standard Error 1.08
Adjusted Mean International Index of Erectile Function (IIEF-2) Scores at Weeks 4, 8, 12 and 24 Erectile Function Score, Week 8	24.3 score on a scale Standard Error 0.80	24.9 score on a scale Standard Error 0.83	24.4 score on a scale Standard Error 1.15
Adjusted Mean International Index of Erectile Function (IIEF-2) Scores at Weeks 4, 8, 12 and 24 Erectile Function Score, Week 12	25.3 score on a scale Standard Error 0.73	25.5 score on a scale Standard Error 0.77	23.6 score on a scale Standard Error 1.04
Adjusted Mean International Index of Erectile Function (IIEF-2) Scores at Weeks 4, 8, 12 and 24 Erectile Function Score, Week 24	25.3 score on a scale Standard Error 0.74	26.1 score on a scale Standard Error 0.79	24.9 score on a scale Standard Error 1.05
Adjusted Mean International Index of Erectile Function (IIEF-2) Scores at Weeks 4, 8, 12 and 24 Orgasmic Function Score, Week 4	9.3 score on a scale Standard Error 0.21	9.0 score on a scale Standard Error 0.22	8.9 score on a scale Standard Error 0.30
Adjusted Mean International Index of Erectile Function (IIEF-2) Scores at Weeks 4, 8, 12 and 24 Orgasmic Function Score, Week 8	8.7 score on a scale Standard Error 0.26	8.7 score on a scale Standard Error 0.27	9.1 score on a scale Standard Error 0.38
Adjusted Mean International Index of Erectile Function (IIEF-2) Scores at Weeks 4, 8, 12 and 24 Orgasmic Function Score, Week 12	9.4 score on a scale Standard Error 0.21	8.9 score on a scale Standard Error 0.22	9.0 score on a scale Standard Error 0.30
Adjusted Mean International Index of Erectile Function (IIEF-2) Scores at Weeks 4, 8, 12 and 24 Orgasmic Function Score, Week 24	8.9 score on a scale Standard Error 0.25	9.1 score on a scale Standard Error 0.26	9.0 score on a scale Standard Error 0.35
Adjusted Mean International Index of Erectile Function (IIEF-2) Scores at Weeks 4, 8, 12 and 24 Sexual Desire Score, Week 4	7.3 score on a scale Standard Error 0.17	7.5 score on a scale Standard Error 0.17	7.1 score on a scale Standard Error 0.24
Adjusted Mean International Index of Erectile Function (IIEF-2) Scores at Weeks 4, 8, 12 and 24 Sexual Desire Score, Week 8	7.4 score on a scale Standard Error 0.16	7.4 score on a scale Standard Error 0.17	7.6 score on a scale Standard Error 0.23
Adjusted Mean International Index of Erectile Function (IIEF-2) Scores at Weeks 4, 8, 12 and 24 Sexual Desire Score, Week 12	7.7 score on a scale Standard Error 0.15	8.0 score on a scale Standard Error 0.16	7.8 score on a scale Standard Error 0.21
Adjusted Mean International Index of Erectile Function (IIEF-2) Scores at Weeks 4, 8, 12 and 24 Sexual Desire Score, Week 24	7.7 score on a scale Standard Error 0.17	7.7 score on a scale Standard Error 0.18	7.8 score on a scale Standard Error 0.24
Adjusted Mean International Index of Erectile Function (IIEF-2) Scores at Weeks 4, 8, 12 and 24 Intercourse Satisfaction Score, Week 4	9.4 score on a scale Standard Error 0.49	10.7 score on a scale Standard Error 0.51	8.5 score on a scale Standard Error 0.69
Adjusted Mean International Index of Erectile Function (IIEF-2) Scores at Weeks 4, 8, 12 and 24 Intercourse Satisfaction Score, Week 8	9.6 score on a scale Standard Error 0.49	9.9 score on a scale Standard Error 0.51	9.0 score on a scale Standard Error 0.70
Adjusted Mean International Index of Erectile Function (IIEF-2) Scores at Weeks 4, 8, 12 and 24 Intercourse Satisfaction Score, Week 12	9.9 score on a scale Standard Error 0.49	10.2 score on a scale Standard Error 0.51	8.3 score on a scale Standard Error 0.69
Adjusted Mean International Index of Erectile Function (IIEF-2) Scores at Weeks 4, 8, 12 and 24 Intercourse Satisfaction Score, Week 24	9.8 score on a scale Standard Error 0.47	10.8 score on a scale Standard Error 0.50	8.9 score on a scale Standard Error 0.67
Adjusted Mean International Index of Erectile Function (IIEF-2) Scores at Weeks 4, 8, 12 and 24 Overall Satisfaction Score, Week 4	7.9 score on a scale Standard Error 0.22	8.0 score on a scale Standard Error 0.22	7.9 score on a scale Standard Error 0.31
Adjusted Mean International Index of Erectile Function (IIEF-2) Scores at Weeks 4, 8, 12 and 24 Overall Satisfaction Score, Week 8	7.9 score on a scale Standard Error 0.21	7.8 score on a scale Standard Error 0.22	7.8 score on a scale Standard Error 0.31
Adjusted Mean International Index of Erectile Function (IIEF-2) Scores at Weeks 4, 8, 12 and 24 Overall Satisfaction Score, Week 12	8.1 score on a scale Standard Error 0.22	8.1 score on a scale Standard Error 0.23	7.6 score on a scale Standard Error 0.31
Adjusted Mean International Index of Erectile Function (IIEF-2) Scores at Weeks 4, 8, 12 and 24 Overall Satisfaction Score, Week 24	8.0 score on a scale Standard Error 0.22	8.1 score on a scale Standard Error 0.23	8.2 score on a scale Standard Error 0.31

SECONDARY outcome

Timeframe: Baseline to Week 24

Population: Safety Population includes all randomized participants who received at least one application of the IMP.

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.

Outcome measures

Outcome measures
Measure	P-3074 + Finasteride Placebo n=181 Participants Participants received topical application of P-3074 contained finasteride 0.25% in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.	P-3074 Vehicle + Finasteride Placebo n=181 Participants Participants received topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.	Oral Finasteride + P-3074 Vehicle n=84 Participants Participants received finasteride 1 mg tablet orally once daily followed by topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) for the 24 weeks.
Local Tolerability as Assessed by Incidence Rate of Skin Irritation Event Via Severity Score for Skin Irritation Scale Dermal Response	0.340 Events per personal years	0.245 Events per personal years	0.661 Events per personal years
Local Tolerability as Assessed by Incidence Rate of Skin Irritation Event Via Severity Score for Skin Irritation Scale Other Effects	0.368 Events per personal years	0.463 Events per personal years	0.755 Events per personal years

SECONDARY outcome

Timeframe: From the start of IMP up to 28 weeks

Population: Safety Population includes all randomized participants who received at least one application of the IMP.

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.

Outcome measures

Outcome measures
Measure	P-3074 + Finasteride Placebo n=181 Participants Participants received topical application of P-3074 contained finasteride 0.25% in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.	P-3074 Vehicle + Finasteride Placebo n=181 Participants Participants received topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.	Oral Finasteride + P-3074 Vehicle n=84 Participants Participants received finasteride 1 mg tablet orally once daily followed by topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) for the 24 weeks.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs TEAEs	75 participants	76 participants	41 participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs Serious TEAEs	4 participants	5 participants	1 participants

Adverse Events

P-3074 + Finasteride Placebo

Serious events: 4 serious events

Other events: 74 other events

Deaths: 0 deaths

P-3074 Vehicle + Finasteride Placebo

Serious events: 5 serious events

Other events: 73 other events

Deaths: 0 deaths

Oral Finasteride + P-3074 Vehicle

Serious events: 1 serious events

Other events: 40 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	P-3074 + Finasteride Placebo n=181 participants at risk Participants received topical application of P-3074 contained finasteride 0.25% in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1mg tablet orally once daily for 24 weeks.	P-3074 Vehicle + Finasteride Placebo n=181 participants at risk Participants received topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.	Oral Finasteride + P-3074 Vehicle n=84 participants at risk Participants received finasteride 1 mg tablet orally once daily followed by topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) for the 24 weeks.
Respiratory, thoracic and mediastinal disorders Nasal septum deviation	0.00% 0/181 • From the start of the IMP up to 28 weeks The data presented here for the safety population which includes all randomized participants who receive at least one application of the IMP.	0.55% 1/181 • Number of events 1 • From the start of the IMP up to 28 weeks The data presented here for the safety population which includes all randomized participants who receive at least one application of the IMP.	0.00% 0/84 • From the start of the IMP up to 28 weeks The data presented here for the safety population which includes all randomized participants who receive at least one application of the IMP.
Respiratory, thoracic and mediastinal disorders Pneumothorax spontaneous	0.55% 1/181 • Number of events 1 • From the start of the IMP up to 28 weeks The data presented here for the safety population which includes all randomized participants who receive at least one application of the IMP.	0.00% 0/181 • From the start of the IMP up to 28 weeks The data presented here for the safety population which includes all randomized participants who receive at least one application of the IMP.	0.00% 0/84 • From the start of the IMP up to 28 weeks The data presented here for the safety population which includes all randomized participants who receive at least one application of the IMP.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/181 • From the start of the IMP up to 28 weeks The data presented here for the safety population which includes all randomized participants who receive at least one application of the IMP.	0.55% 1/181 • Number of events 1 • From the start of the IMP up to 28 weeks The data presented here for the safety population which includes all randomized participants who receive at least one application of the IMP.	0.00% 0/84 • From the start of the IMP up to 28 weeks The data presented here for the safety population which includes all randomized participants who receive at least one application of the IMP.
Injury, poisoning and procedural complications Exposure via father	0.00% 0/181 • From the start of the IMP up to 28 weeks The data presented here for the safety population which includes all randomized participants who receive at least one application of the IMP.	0.55% 1/181 • Number of events 1 • From the start of the IMP up to 28 weeks The data presented here for the safety population which includes all randomized participants who receive at least one application of the IMP.	0.00% 0/84 • From the start of the IMP up to 28 weeks The data presented here for the safety population which includes all randomized participants who receive at least one application of the IMP.
Injury, poisoning and procedural complications Road traffic accident	0.55% 1/181 • Number of events 1 • From the start of the IMP up to 28 weeks The data presented here for the safety population which includes all randomized participants who receive at least one application of the IMP.	0.00% 0/181 • From the start of the IMP up to 28 weeks The data presented here for the safety population which includes all randomized participants who receive at least one application of the IMP.	1.2% 1/84 • Number of events 1 • From the start of the IMP up to 28 weeks The data presented here for the safety population which includes all randomized participants who receive at least one application of the IMP.
Injury, poisoning and procedural complications Skull fractured base	0.55% 1/181 • Number of events 1 • From the start of the IMP up to 28 weeks The data presented here for the safety population which includes all randomized participants who receive at least one application of the IMP.	0.00% 0/181 • From the start of the IMP up to 28 weeks The data presented here for the safety population which includes all randomized participants who receive at least one application of the IMP.	0.00% 0/84 • From the start of the IMP up to 28 weeks The data presented here for the safety population which includes all randomized participants who receive at least one application of the IMP.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/181 • From the start of the IMP up to 28 weeks The data presented here for the safety population which includes all randomized participants who receive at least one application of the IMP.	0.55% 1/181 • Number of events 1 • From the start of the IMP up to 28 weeks The data presented here for the safety population which includes all randomized participants who receive at least one application of the IMP.	0.00% 0/84 • From the start of the IMP up to 28 weeks The data presented here for the safety population which includes all randomized participants who receive at least one application of the IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anogenital warts	0.00% 0/181 • From the start of the IMP up to 28 weeks The data presented here for the safety population which includes all randomized participants who receive at least one application of the IMP.	0.55% 1/181 • Number of events 1 • From the start of the IMP up to 28 weeks The data presented here for the safety population which includes all randomized participants who receive at least one application of the IMP.	0.00% 0/84 • From the start of the IMP up to 28 weeks The data presented here for the safety population which includes all randomized participants who receive at least one application of the IMP.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.55% 1/181 • Number of events 1 • From the start of the IMP up to 28 weeks The data presented here for the safety population which includes all randomized participants who receive at least one application of the IMP.	0.00% 0/181 • From the start of the IMP up to 28 weeks The data presented here for the safety population which includes all randomized participants who receive at least one application of the IMP.	0.00% 0/84 • From the start of the IMP up to 28 weeks The data presented here for the safety population which includes all randomized participants who receive at least one application of the IMP.
Vascular disorders Haematoma	0.55% 1/181 • Number of events 1 • From the start of the IMP up to 28 weeks The data presented here for the safety population which includes all randomized participants who receive at least one application of the IMP.	0.00% 0/181 • From the start of the IMP up to 28 weeks The data presented here for the safety population which includes all randomized participants who receive at least one application of the IMP.	0.00% 0/84 • From the start of the IMP up to 28 weeks The data presented here for the safety population which includes all randomized participants who receive at least one application of the IMP.
Vascular disorders Hypertension	0.55% 1/181 • Number of events 1 • From the start of the IMP up to 28 weeks The data presented here for the safety population which includes all randomized participants who receive at least one application of the IMP.	0.00% 0/181 • From the start of the IMP up to 28 weeks The data presented here for the safety population which includes all randomized participants who receive at least one application of the IMP.	0.00% 0/84 • From the start of the IMP up to 28 weeks The data presented here for the safety population which includes all randomized participants who receive at least one application of the IMP.

Other adverse events

Additional Information

Francesco Scarci

Polichem S.A.

Phone: +41 091 9864 005

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER