Back to resultsStudy to Evaluate the Efficacy and Safety of P-3074 Topical Solution in the Treatment of Androgenetic Alopecia
Primary Purpose
Alopecia, Androgenetic
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
P-3074
Finasteride
P-3074 Vehicle
Finasteride Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Alopecia, Androgenetic
Eligibility Criteria
Inclusion Criteria:
- Written informed consent before starting any study related procedures;
- Men 18 to 40 years of age;
- Men with mild to moderate vertex male pattern hair loss according to a modified Norwood/Hamilton classification scale (III vertex, IV or V);
- Participants willing to have a tattoo in the target area;
- Outpatients;
- Ability to comprehend the full nature and purpose of the study, including possible risks and side effects;
- Ability to co-operate with the Investigator and to comply with the requirements of the entire study.
Exclusion Criteria:
- Clinically relevant abnormal skin scalp findings which could interfere with the aim of the study; in particular, abrasion, actinic keratosis, inflammatory disorders or any other abnormality;
- Participants who had had hair transplant surgery or hair weaving;
- Clinically relevant abnormal laboratory values indicative of physical illness;
- Ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may affect the outcome of the study;
- History of local infections of skin and subcutaneous tissues of the head in the 3-months period before the trial inclusion;
- Relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases, that may interfere with the aim of the study;
- Suspicion of malignancy, including prostate cancer;
- History of infertility or difficulty fathering children;
- Participants who wish to conceive children during the study or whose sexual partner(s) is pregnant;
- Participants with active seborrheic dermatitis;
- History of varicocele;
- Concurrent use of systemic corticosteroids, topical corticosteroids in the balding area studied, anabolic steroids, or over-the-counter "hair restorers";
- Use of the following drugs with antiandrogenic properties within 6 months of study entry: flutamide, cyproterone acetate, estrogen, progesterone, cimetidine, spironolactone or ketoconazole;
- Participants who had been treated with any of the following drugs within the past year: minoxidil (topical or oral), zidovudine, cyclosporine, diazoxide, phenytoin, systemic interferon, psoralens, streptomycin, penicillamine, benoxaprofen, tamoxifen, phenothiazines or cytotoxic agents;
- Use of finasteride or dutasteride within previous 12 months;
- Light or laser treatment of scalp within previous 3 months;
- Participation in the evaluation of any drug for 3 months before this study, calculated from the first day of the month following the last visit of the previous study;
- History of drug, alcohol [>2 drinks/day defined according to USDA Dietary Guidelines 2010], caffeine (>5 cups coffee/tea/day) or tobacco abuse (10 cigarettes/day).
Sites / Locations
- Site #103
- Site #104
- Site #102
- Site #101
- Site #211
- Site #202
- Site #212
- Site #216
- Site #210
- Site #217
- Site #221
- Site #203
- Site #204
- Site #206
- Site #214
- Site #218
- Site #213
- Site #215
- Site #220
- Site #208
- Site #219
- Site #209
- Site #201
- Site #303
- Site #309
- Site #302
- Site #308
- Site #301
- Site #307
- Site #401
- Site #402
- Site #407
- Site #411
- Site #409
- Site #403
- Site #406
- Site #408
- Site #410
- Site #503
- Site #505
- Site #502
- Site #507
- Site #501
- Site #504
- Site #508
- Site #506
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Active Comparator
Arm Label
P-3074 + Finasteride Placebo
P-3074 Vehicle + Finasteride Placebo
Oral Finasteride + P-3074 Vehicle
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
Adjusted Mean Change From Baseline in Hair Growth Assessed by Target Area Hair Count (TAHC) in the Vertex at 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 Outcome Measures
Adjusted Mean Change From Baseline in Hair Growth Assessed by TAHC in the Vertex at 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.
Adjusted Mean Change From Baseline in Target Area Hair Width (TAHW) in the Vertex at Weeks 12 and 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.
Adjusted Mean Overall Male Hair Growth Questionnaire (MHGQ) Score as Assessed by the Participant at Weeks 12 and 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.
Adjusted Mean Change From Baseline in Participants Hair Growth/Loss Assessed for the Vertex by Investigator at Weeks 12 and 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.
Adjusted Mean Change From Baseline in Participants Hair Growth/Loss at Weeks 12 and 24, Assessed for the Vertex by Blind Assessor
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.
Adjusted Mean International Index of Erectile Function (IIEF-2) Scores at 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.
Local Tolerability as Assessed by Incidence Rate of Skin Irritation Event Via Severity Score for Skin Irritation Scale
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.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03004469
Brief Title
Study to Evaluate the Efficacy and Safety of P-3074 Topical Solution in the Treatment of Androgenetic Alopecia
Official Title
A Multicentre, Randomized, Double-blind, Parallel-group, Controlled Study, to Assess the Efficacy and Safety of P-3074 Cutaneous Spray, Solution, in the Treatment of Male Pattern Baldness
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
August 2, 2016 (Actual)
Primary Completion Date
March 5, 2018 (Actual)
Study Completion Date
March 5, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Polichem S.A.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to confirm the clinical efficacy and the safety of P-3074 in participants with androgenetic alopecia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia, Androgenetic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
458 (Actual)
8. Arms, Groups, and Interventions
Arm Title
P-3074 + Finasteride Placebo
Arm Type
Experimental
Arm Description
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.
Arm Title
P-3074 Vehicle + Finasteride Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Oral Finasteride + P-3074 Vehicle
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
P-3074
Other Intervention Name(s)
finasteride topical solution
Intervention Type
Drug
Intervention Name(s)
Finasteride
Other Intervention Name(s)
Propecia
Intervention Type
Drug
Intervention Name(s)
P-3074 Vehicle
Other Intervention Name(s)
Vehicle of P-3074
Intervention Type
Drug
Intervention Name(s)
Finasteride Placebo
Other Intervention Name(s)
Placebo of Finasteride
Primary Outcome Measure Information:
Title
Adjusted Mean Change From Baseline in Hair Growth Assessed by Target Area Hair Count (TAHC) in the Vertex at Week 24
Description
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.
Time Frame
Baseline and Week 24
Secondary Outcome Measure Information:
Title
Adjusted Mean Change From Baseline in Hair Growth Assessed by TAHC in the Vertex at Week 12
Description
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.
Time Frame
Baseline and Week 12
Title
Adjusted Mean Change From Baseline in Target Area Hair Width (TAHW) in the Vertex at Weeks 12 and 24
Description
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.
Time Frame
Baseline, Week 12 and Week 24
Title
Adjusted Mean Overall Male Hair Growth Questionnaire (MHGQ) Score as Assessed by the Participant at Weeks 12 and 24
Description
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.
Time Frame
Week 12 and Week 24
Title
Adjusted Mean Change From Baseline in Participants Hair Growth/Loss Assessed for the Vertex by Investigator at Weeks 12 and 24
Description
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.
Time Frame
Baseline, Week 12 and Week 24
Title
Adjusted Mean Change From Baseline in Participants Hair Growth/Loss at Weeks 12 and 24, Assessed for the Vertex by Blind Assessor
Description
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.
Time Frame
Baseline, Week 12 and Week 24
Title
Adjusted Mean International Index of Erectile Function (IIEF-2) Scores at Weeks 4, 8, 12 and 24
Description
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.
Time Frame
Weeks 4, 8, 12 and 24
Title
Local Tolerability as Assessed by Incidence Rate of Skin Irritation Event Via Severity Score for Skin Irritation Scale
Description
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.
Time Frame
Baseline to Week 24
Title
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
Description
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.
Time Frame
From the start of IMP up to 28 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Written informed consent before starting any study related procedures;
Men 18 to 40 years of age;
Men with mild to moderate vertex male pattern hair loss according to a modified Norwood/Hamilton classification scale (III vertex, IV or V);
Participants willing to have a tattoo in the target area;
Outpatients;
Ability to comprehend the full nature and purpose of the study, including possible risks and side effects;
Ability to co-operate with the Investigator and to comply with the requirements of the entire study.
Exclusion Criteria:
Clinically relevant abnormal skin scalp findings which could interfere with the aim of the study; in particular, abrasion, actinic keratosis, inflammatory disorders or any other abnormality;
Participants who had had hair transplant surgery or hair weaving;
Clinically relevant abnormal laboratory values indicative of physical illness;
Ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may affect the outcome of the study;
History of local infections of skin and subcutaneous tissues of the head in the 3-months period before the trial inclusion;
Relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases, that may interfere with the aim of the study;
Suspicion of malignancy, including prostate cancer;
History of infertility or difficulty fathering children;
Participants who wish to conceive children during the study or whose sexual partner(s) is pregnant;
Participants with active seborrheic dermatitis;
History of varicocele;
Concurrent use of systemic corticosteroids, topical corticosteroids in the balding area studied, anabolic steroids, or over-the-counter "hair restorers";
Use of the following drugs with antiandrogenic properties within 6 months of study entry: flutamide, cyproterone acetate, estrogen, progesterone, cimetidine, spironolactone or ketoconazole;
Participants who had been treated with any of the following drugs within the past year: minoxidil (topical or oral), zidovudine, cyclosporine, diazoxide, phenytoin, systemic interferon, psoralens, streptomycin, penicillamine, benoxaprofen, tamoxifen, phenothiazines or cytotoxic agents;
Use of finasteride or dutasteride within previous 12 months;
Light or laser treatment of scalp within previous 3 months;
Participation in the evaluation of any drug for 3 months before this study, calculated from the first day of the month following the last visit of the previous study;
History of drug, alcohol [>2 drinks/day defined according to USDA Dietary Guidelines 2010], caffeine (>5 cups coffee/tea/day) or tobacco abuse (10 cigarettes/day).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Massana, MD
Organizational Affiliation
Almirall, S.A.
Official's Role
Study Director
Facility Information:
Facility Name
Site #103
City
Brussels
Country
Belgium
Facility Name
Site #104
City
Brussels
Country
Belgium
Facility Name
Site #102
City
Brussel
Country
Belgium
Facility Name
Site #101
City
Gent
Country
Belgium
Facility Name
Site #211
City
Augsburg
Country
Germany
Facility Name
Site #202
City
Berlin
Country
Germany
Facility Name
Site #212
City
Berlin
Country
Germany
Facility Name
Site #216
City
Bochum
Country
Germany
Facility Name
Site #210
City
Dresden
Country
Germany
Facility Name
Site #217
City
Dresden
Country
Germany
Facility Name
Site #221
City
Dresden
Country
Germany
Facility Name
Site #203
City
Dusseldorf
Country
Germany
Facility Name
Site #204
City
Freiburg
Country
Germany
Facility Name
Site #206
City
Hamburg
Country
Germany
Facility Name
Site #214
City
Hamburg
Country
Germany
Facility Name
Site #218
City
Hamburg
Country
Germany
Facility Name
Site #213
City
Hannover
Country
Germany
Facility Name
Site #215
City
Karlsruhe
Country
Germany
Facility Name
Site #220
City
Lübeck
Country
Germany
Facility Name
Site #208
City
Münster
Country
Germany
Facility Name
Site #219
City
Potsdam
Country
Germany
Facility Name
Site #209
City
Schwerin
Country
Germany
Facility Name
Site #201
City
Wuppertal
Country
Germany
Facility Name
Site #303
City
Budapest
Country
Hungary
Facility Name
Site #309
City
Budapest
Country
Hungary
Facility Name
Site #302
City
Debrecen
Country
Hungary
Facility Name
Site #308
City
Satoraljaujhely
Country
Hungary
Facility Name
Site #301
City
Szolnok
Country
Hungary
Facility Name
Site #307
City
Szombathely
Country
Hungary
Facility Name
Site #401
City
Chelyabinsk
Country
Russian Federation
Facility Name
Site #402
City
Moscow
Country
Russian Federation
Facility Name
Site #407
City
Moscow
Country
Russian Federation
Facility Name
Site #411
City
Moscow
Country
Russian Federation
Facility Name
Site #409
City
Rostov
Country
Russian Federation
Facility Name
Site #403
City
Ryazan
Country
Russian Federation
Facility Name
Site #406
City
Saint-Petersburg
Country
Russian Federation
Facility Name
Site #408
City
Saint-Petersburg
Country
Russian Federation
Facility Name
Site #410
City
Yaroslavl
Country
Russian Federation
Facility Name
Site #503
City
Alicante
Country
Spain
Facility Name
Site #505
City
Barakaldo
Country
Spain
Facility Name
Site #502
City
Barcelona
Country
Spain
Facility Name
Site #507
City
Cordoba
Country
Spain
Facility Name
Site #501
City
Madrid
Country
Spain
Facility Name
Site #504
City
Madrid
Country
Spain
Facility Name
Site #508
City
Madrid
Country
Spain
Facility Name
Site #506
City
Pamplona
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study to Evaluate the Efficacy and Safety of P-3074 Topical Solution in the Treatment of Androgenetic Alopecia
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