E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Mild to moderate acne vulgaris in adult patients. |
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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 |
Compare how well the 3 following treatments improve mild to moderate acne vulgaris:
1. Intense pulsed light (IPL)
2. IPL + a photosensitiser (which augments IPL's activity). Explanatory note: The use of LIGHT + PHOTOSENSITISER together as a form of treatment is called 'photodynamic therapy' or PDT. The photosensitiser to be used for this study is called 'methyl aminolevulinate' or 'MAL' (Metvix, Galderma UK Ltd). Therefore PDT using MAL can be referred to as MAL-PDT.
3. 0.1% Adapalene gel (Differin) |
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E.2.2 | Secondary objectives of the trial |
1.Assess whether MAL-PDT and IPL can be included within the acne-management algorithm. 2.Objectively assess the tolerability and efficacy of 16% MAL for use in the treatment of acne with PDT. 3.Assess whether IPL and PDT induce a long-term improvement of mild to moderate acne vulgaris and the approximate length of this remission. 4.Assist with the development of standardised IPL machine settings and treatment protocols for patients with mild to moderate acne. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion Criteria 1. Mild to moderate facial (face = area from hair line to jaw line) acne vulgaris with at least 15 inflammatory lesions and/or non-inflammatory lesions, but no more than three nodulocystic lesions. Thus, not exceeding Leeds grade 7. 2. Patients willing to have ONLY their face treated. 3. Skin phototypes I – III 4. Patients who are willing and able to provide written informed consent. 5. Patients who agree to not use sun-beds or undergo any UV light treatment for 4 weeks prior to entering the study and are willing to minimise the amount of exposure to direct sunlight for the duration of the study. 6. Patients who have access to emails and are willing to reveal their emails to the study team.
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E.4 | Principal exclusion criteria |
Exclusion Criteria 1. Severe acne (>3 nodules and/or cysts present) or presence of scarring 2. Pregnancy 3. Lactating females 4. Use of anti-androgen containing contraceptives 5. Mental incompetence 6. History of hypersensitivity to any of the study drugs or their excipients. i.e. adapalene, Metvix™ (e.g. peanut oil, soya), Unguentum M®. 7. Keloids or tendency to heal with keloids 8. Cosmetic treatment: a. In the previous year with collagen, dermabrasion and laser resurfacing. b. Alpha hydroxyl acids within 3 months c. Microdermabrasion within 3 months 9. Photosensitivity disorders e.g. a. solar urticaria b. Porphyrias or allergy to porphyrins c. Epilepsy 10. Systemic retinoid use in the past 12 months 11. Use of Vitamin A supplements > 2000 IU /day. 12. Oral antibiotics and topical retinoids for preceding 4 weeks. 13. Systemic medications such as: steroids, immunosuppressants, statins and preparations containing St. John’s wort. 14. Oral photosensitisers within last 4 weeks (see Patient CRF) 15. Previous treatment with IPL or lasers to the areas of interest within the last 12 months. 16. Severe systemic diseases such as: impaired renal or liver function; regional enteritis or ulcerative colitis; a history of antibiotic-associated colitis; severe cardiovascular, neurological disease, or any other disease that may interfere with the evaluation of the study medications. 17. Patients with psoriasis, rosacea, allergic rashes, bacterial, viral or fungal infections of the facial skin, or other diseases of the facial skin. 18. Patients who are unlikely to be available for the duration of the follow-up. 19. Persons involved in another clinical trial for the duration of this study. 20. Persons who have another member of their household taking part in this study.
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E.5 End points |
E.5.1 | Primary end point(s) |
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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 | Yes |
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 | No |
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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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 | 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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Completion of all trial procedures by participants at Week 16. However this is not the last visit for all participants. Patients from the PDT arms will be asked to keep a diary to document how their acne is doing for another 44 weeks after that. Patients do not have to agree to keep a diary, even if they agree to take part in the first part of the study. This is to assess long term benefits of treatment in the PDT arms. |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |