| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Androgenic alopecia in men |
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| E.1.1.1 | Medical condition in easily understood language |
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| E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 14.0 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10068558 |
| E.1.2 | Term | Androgenic alopecia |
| E.1.2 | System Organ Class | 10040785 - Skin and subcutaneous tissue disorders |
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| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
| The objectives of this study are to evaluate the safety and efficacy of bimatoprost solution 0.03%, 0.1%, and 0.3% once-daily topical application compared with vehicle and minoxidil in increasing scalp hair growth in male subjects with AGA. |
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| E.2.2 | Secondary objectives of the trial |
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| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
The following are requirements for entry into the study:
1. Males 18 to 49 years of age with mild to moderate AGA of the vertex area of the scalp (modified Norwood Hamilton scale classification of IIIv, IV, or V) who report scalp hair growth/coverageloss ongoing for at least 1 year
2. Written informed consent has been obtained
3. Written documentation has been obtained in accordance with the relevant country and
local privacy requirements, where applicable (eg, Written Authorization for Use and
Release of Health and Research Study Information [US sites] and written Data
Protection consent [EU sites])
4. Standardized global photographs of the scalp at the screening visit of acceptable quality for assessment, as verified by Canfield Scientific, Inc. (Canfield)
5. Ability to follow study instructions and willingness to complete all required procedures and visits, including micro-dot tattoo and macro photography procedures
6. Hair length in non-balding areas ≥ 2 cm (3/4 inch) around the vertex region of scalp and willing to maintain the same hair style, approximate length, and hair color throughout the duration of the study |
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| E.4 | Principal exclusion criteria |
The following are criteria for exclusion from participating in the study:
1. An uncontrolled systemic disease
2. Subjects with a history of significant cardiovascular disease, family history of long QT syndrome, or a clinically significant ECG abnormality at the screening visit.
3. History or current evidence of drug or alcohol abuse within 12 months prior to study entry
4. Subjects known to be HIV positive
5. Subjects with sensitive, irritated, or abraded scalp area
6. Subjects with global scalp hair thinning, including occipital areas
7. Subjects with any known scarring, disease, infection, or abnormality of the scalp or hair shaft or systemic disease that could prevent hair growth or produce abnormal hair (for example, seborrheic dermatitis, psoriatic dermatitis, alopecia areata, cicatricial alopecia, uncontrolled hyperthyroidism/hypothyroidism, tinea infections, genetic disorders)
8. Subjects who have received hair transplants or had scalp reductions
9. Concurrent use of hair weavings, hair extensions, or wigs or within 3 months prior to study entry
10. Concurrent use of topical steroidal or nonsteroidal anti-inflammatory drugs applied to the scalp, or within 4 weeks prior to study entry; inhaled glucocorticoids are allowed
11. Concurrent treatment or within 6 months prior to study entry of any of the following:
a. Prostaglandins or prostamides
b. Minoxidil (oral or topical)
c. Drugs with anti-androgenic properties (for example, cyproterone acetate, spironolactone, flutamide, bicalutamide, cimetidine, oral ketoconazole)
d. Topical or oral estrogen, progesterone, tamoxifen
12. Concurrent systemic treatment that may affect hair growth (for example, 5 alpha reductase inhibitors such as finasteride and dutasteride, cytotoxic agents, cyclosporine, diazoxide, anabolic steroids) or within 12 months prior to study entry
13. Known allergy or sensitivity to the study medication or its components
14. Known allergy, sensitivity, or contraindication to minoxidil
15. Known allergy or sensitivity to tattoo ink
16. Current enrollment in an investigational drug or device study or participation in such a study within 30 days prior to study entry
17. Subject has a condition or is in a situation which, in the investigator’s opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject’s participation in the study |
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| E.5 End points |
| E.5.1 | Primary end point(s) |
Target Area Hair Count
The co-primary efficacy measure will be the Target Area Hair Count (TAHC) as measured in terminal hairs/cm2 using digital image analysis.
The total number of terminal hairs (hair ≥ 30 microns in width) is calculated from macro photographs for each visit. The target area used to count TAHC is a 1 cm2 circular area of clipped hair (length approximately 1 mm) located at the anterior leading edge of the vertex thinning area of the scalp and centered with a micro-dot tattoo to ensure the same target site is reproduced at each visit.
The co-primary efficacy endpoint is defined as change from baseline in TAHC (terminal hairs/cm2) at month 6 using digital image analysis.
Subject’s Assessment of Change of Scalp Hair Growth/Coverage
Another co-primary efficacy measure will be the subject’s assessment of change of scalp hair growth as measured by the Subject Self Assessment (SSA) question 1 using a 7 point scale.
The SSA question 1 is a subject-rated assessment of their change in scalp hair growth using an ordinal, 7-point scale. The subject uses a standardized global photograph of their own scalp at the start of the study (baseline status) side-by-side with a standardized global photograph of their own scalp at the current visit to give a comparative score at each visit after baseline. The scale point ranges from -3 to +3, where -3 = greatly decreased, -2 = moderately decreased, -1 = slightly decreased, 0 = remained the same, +1 = slightly increased, +2 = moderately increased, and +3 = greatly increased.
The co-primary efficacy endpoint is defined as the distribution of SSA question 1 scores at month 6 using a 7-point scale. |
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| E.5.1.1 | Timepoint(s) of evaluation of this end point |
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| E.5.2 | Secondary end point(s) |
Secondary efficacy measures include:
• Investigator’s assessment of change of scalp hair growth as measured by Investigator Global Assessment (IGA).
The IGA is an investigator-graded live assessment using an ordinal, 7-point scale. The investigator uses a standardized global photograph of the scalp at the start of the study (baseline) as a reference to give a comparative score at each visit. The scale points range from -3 to +3, where -3 = greatly decreased, -2 = moderately decreased, -1 = slightly decreased, 0 = remained the same, +1 = slightly increased, +2 = moderately increased, and +3 = greatly increased.
• Global Panel Review (GPR).
An independent panel of 3-5 dermatologists will evaluate a subject’s scalp hair in a blinded manner based on evaluation of standardized global photographs. In contrast to IGA, there is no live assessment; all assessments are performed from photographs alone. The panel is blinded to subjects’ treatment and is given a set of photographs for each subject and each visit. The baseline photo is identified and remaining visit photos are given a comparative score. The GPR uses anis a panel-reviewed, ordinal, 7-point scale. The scale points range from -3 to +3, where -3 = greatly decreased, -2 = moderately decreased, -1 = slightly decreased, 0 = remained the same, +1 = slightly increased, +2 = moderately increased, and +3 = greatly increased.
• Target Area Hair Width (TAHW) in µm/cm2 as measured using digital image analysis. The width of each terminal hair (hair ≥ 30 microns in width) is calculated from macro photographs resulting in a summary measurement for each visit. The target area used to calculate TAHW is a 1cm2 circular area of clipped hair (length approximately 1 mm) located at the anterior leading edge of the vertex thinning area of the scalp and centered with a micro-dot tattoo to ensure the same target site is reproduced at each visit.
• Target Area Hair Darkness (TAHD) in intensity units as measured using digital image analysis.
The secondary efficacy endpoints include: 1) the distribution of IGA scores at month 6 using a 7-point scale, 2) the distribution of GRP scores at month 6 using a 7-point scale, 3) change from baseline in TAHW (µm/cm2) at month 6 using digital image analysis, and 4) change from baseline in TAHD (intensity units) at month 6 using digital image analysis. |
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| E.5.2.1 | Timepoint(s) of evaluation of this end point |
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| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | Yes |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | Yes |
| E.6.13.1 | Other scope of the trial description |
| PK sampling is undertaken on US subjects only. |
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| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | Yes |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | Yes |
| E.8.1.7.1 | Other trial design description |
| There is an open-label cohort. |
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| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | Yes |
| E.8.2.3 | Other | Yes |
| E.8.2.3.1 | Comparator description |
| Minoxidil 5% (PR4) is an open-label comparator. |
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| E.8.2.4 | Number of treatment arms in the trial | 5 |
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 9 |
| E.8.5 | The trial involves multiple Member States | No |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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| E.8.7 | Trial has a data monitoring committee | No |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
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| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 0 |
| E.8.9.1 | In the Member State concerned months | 8 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 0 |
| E.8.9.2 | In all countries concerned by the trial months | 8 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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