A comparison of the clinical efficacies of Intense Pulsed Light (IPL), PhotoDynamic Therapy (PDT) and adapalene in the treatment of mild to moderate acne vulgaris

Not Applicable

Completed

• Conditions: Acne; Skin and Connective Tissue Diseases; Acne vulgaris

• Registration Number: ISRCTN52474223
• Lead Sponsor: Cardiff University (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-05-30
• Study Completion: 2012-08-13
• Last Update Posted: 30 May 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 37

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified