E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Androgenetic Alopecia - Male Pattern Baldness. |
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MedDRA Classification |
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 |
To determine the efficacy of ICX-TRC in androgenetic alopecia |
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E.2.2 | Secondary objectives of the trial |
Safety analysis and efficacy up to 48 weeks post treatment |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Males aged 18-60 years, who are ambulatory and, in the opinion of the investigator, in good general physical and mental health.
Individuals with androgenetic alopecia characterised as male pattern baldness using the Norwood - Hamilton scale stage IV to VII.
Individuals who are willing and able to supply a sample of scalp tissue containing greater than 120 hair follicles (0.5cm2 - 2cm2 strip of tissue).
Individuals willing to participate in the study and follow its requirements.
Individuals able to give informed voluntary consent and able to estimate own risks and benefits of participation.
Individuals, who are, in the opinion of the investigator, able to understand this study, co-operate with the study procedures and are willing to return to the clinic for all the required follow-up visits.
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E.4 | Principal exclusion criteria |
Individuals who do not have MPB.
Individuals younger than 18 years of age.
Individuals with abnormal blood biochemistry defined as three times that of the upper limit of the normal range and/or any other abnormal laboratory finding considered clinically significant.
Individuals who have received anticoagulant medication, including Warfarin, within 7 days of screening.
Individuals who participated in this or another study with any investigational drug or device within the past 28 days.
Individuals with intended hair transplant in the target treatment area during the study duration.
Individuals with recent transplant in the area to be treated with ICX-TRC.
Individuals with life expectancy of less than 9 months, terminal conditions or factors making follow-up difficult (no fixed address, telephone etc.).
Individuals who have begun a course of finasteride or minoxidal in the last year. (Subjects currently using these compounds who have been using them continuously for at least a year are eligible)
Individuals who intend to have a major surgical intervention within 6 months of enrolment in the study.
Individuals with a history of any illness or condition that, in the opinion of the investigator, might mask the results of the study and/or pose additional risk to the individual e.g. uncontrolled thyroid condition or type I/II diabetes mellitus, uncontrolled hypertension, bleeding disorders, autoimmune disorders, long term steroid use, scalp clinical infection, other skin conditions: severe scarring alopecia, infection, inflammation (e.g. seborrhoeic dermatitis).
Individuals with, or with suspected, malignancy.
Individuals with sensitivity to HypoThermosol-FRS®.
Individuals with a know hypersensitivity to, or a religious or ethical objection to, bovine or porcine products.
Individuals who have a known transmissible disease.
Individuals with intolerance to compounds used in this protocol (Chlorhexidine wash, Isopropropyl Alcohol, Diazepam, Saline Tumescent Solution, Adrenaline, Lignocaine, Coproxamol).
Individuals who, in the opinion of the investigator, have an existing condition that would compromise their participation and follow-up in this study.
Individuals previously enrolled and treated in this clinical trial.
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E.5 End points |
E.5.1 | Primary end point(s) |
Hair growth at 6, 12, 24, 36 and 48 weeks as determined by the investigator.
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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 | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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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Last patient last visit as defined in the protocol |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |