Acne Skin and Connective Tissue Diseases Acne vulgaris
Conditions
Interventions
Treatment schedule:
PDT-MAL arm: Full-face treatments every 2 weeks x 4
PDT-Placebo arm: Full-face treatments every 2 weeks x 4
Adapalene group: Partici
Double passes of: 20-40 J/cm2, 15 pulses, 5 ms duration, 20 ms delay (20 J/cm2, 15 x 5 x 20).
Adapalene gel
Sponsors
Cardiff University (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current information as of 04/11/2009: 1. Aged 18 - 50 years, both males and females 2. 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. 3. Patients willing to have only their face treated 4. Skin phototypes I?III 5. Patients who are willing and able to provide written informed consent 6. 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 7. Patients who have access to email accounts and are willing to reveal their email addresses to the study team Initial information at time of registration 1. Aged 18 - 50 years, both males and females 2. 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. 3. Patients willing to have only their face treated 4. Skin phototypes I?III 5. Patients who are willing and able to provide written informed consent 6. 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 7. Patients who own a mobile phone and are willing to reveal their number to and receive text messages from the study team
Exclusion criteria
Exclusion criteria: Current information as of 04/11/2009: 1. Severe acne (>3 nodules and/or cysts present) or presence of scarring 2. Pregnancy and women contemplating 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: 8.1. In the previous year with collagen, dermabrasion and laser resurfacing. 8.2. Alpha hydroxyl acids within 3 months 8.3. Microdermabrasion within 3 months 9. Photosensitivity disorders e.g. solar urticaria 9.1. Porphyrias or allergy to porphyrins 9.2. 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, immunosuppressant, 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, acne rosacea, allergic rashes, bacterial, viral or fungal infections of the facial skin, or other diseases of the facial skin 18. Patients with mild to moderate acne who have not tried over the counter treatment 19. Patients who are unlikely to be available for the duration of the follow-up 20. Persons involved in another clinical trial for the duration of this study 21. Persons who have another member of their household taking part in this study Initial information at time of registration: 1. Severe acne (>2 nodules and/or cysts present) or presence of scarring 2. Pregnancy 3. Use of anti-androgen containing contraceptives 4. Mental incompetence 5. History of hypersensitivity to any of the study drugs or their excipients. i.e. adapalene, Metvix™ (e.g. peanut oil, soya), Unguentum M® 6. Keloids or tendency to heal with keloids 7. Cosmetic treatment: 7.1. In the previous year with collagen, dermabrasion and laser resurfacing 7.2. Alpha hydroxyl acids within the last month 7.3. Microdermabrasion within the last 3 months 8. Photosensitivity disorders e.g. solar urticaria 8.1. Porphyrias or allergy to porphyrins 8.2. Epilepsy 9. Systemic retinoid use in the past 12 months 10. Use of Vitamin A supplements >2000 IU /day 11. Oral antibiotics and topical retinoids for preceding 4 weeks 12. Sy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current infomation as of 04/11/2009: Lesion counts. The face will be divided into five areas. The types of lesions are classified as macules, comedones, papules, pustules, nodules and cysts. These will be counted in at least one of five possible facial cosmetic units before treatment. Subsequent lesion counts will be repeated in the chosen quadrant. Outcomes will be measured at baseline, weeks 8, 11 and 16 in phase 1 (treatment phase) and weeks 38 and 60 for phase 2 (follow-up phase, PDT arms only). Initial information at time of registration: Lesion counts at baseline, Week 12 and 16, Month 7*, 10*, 13* and 16*. *Follow-up for Months 7 to 16 applies only to the PDT arms. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current information as of 04/11/2009: 1. Leeds Revised Acne Grading System scores measured at baseline, week 8, 11,16, 38 and 60 2. Seborrhoea measured using SM-815 sebumeter measured at baseline, week 8, 11,16, 38 and 60 3. P. acnes counts and culture measured at baseline, week 8, 11,16 and 60 4. P. acnes fluorescence photography measured at baseline, week 8, 11,16 and 60 5. Acne-specific Quality of Life Assessments (Acne QoL) measured at baseline, week 8, 11,16 and 60 6. Dermatology Life Quality Index (DLQI) measured at baseline, week 8, 11,16 and 60 7. The Family Dermatology Life Quality index (FDLQI) measured at baseline, week 16 and 60 8. Pain scores measured at day 1, week 3, 5, and 7 9. Subjective global assessment of acne improvement measured at baseline, week 8, 11 and 16 Initial information at time of registration: 1. Leeds Revised Acne Grading System scores at baseline, Week 12 and 16, Month 7*, 10*, 13* and 16* 2. Seborrhoea at baseline, Week 12 and 16, Month 7*, 10*, 13* and 16* 3. P. acnes counts at baseline and Week 7 4. P. acnes fluorescence photography. For all arms, this will be carried out at baseline, Weeks 7, 12 and 16, Months 7*, 10*, 13* and 16* 5. Dermatology Life Quality Index (DLQI) and/or Acne Quality of Life scale at baseline, Week 12 and 16 6. Pain scores (only in PDT-MAL and PDT-Placebo arms), assessed by a visual analogue scale (VAS) at Day 1 (Week 1), Week 3, 5 and 7 7. Subjective global assessment of acne improvement at baseline, Weeks 12 and 16 *Follow-up for Months 7 to 16 applies only to the PDT arms. | — |
Countries
United Kingdom, Wales
Outcome results
None listed