Randomised, controlled, double-blind, parallel group clinical trial evaluating the efficacies and safety of methyl-aminolevulinate photodynamic therapy and intense pulsed light, administered as placebo-photodynamic therapy, compared with the efficacy of adapalene 0.1% gel in the treatment of adults with mild to moderate acne vulgaris. - IPL, PDT & Adapalene. Version 1.8

Active, not recruiting

• Conditions: Mild to moderate acne vulgaris in adult patients.

• Registration Number: EUCTR2008-000475-25-GB
• Lead Sponsor: Cardiff University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-09
• Last Update Posted: 28 August 2012

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: Not specified

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified