EUCTR2008-000475-25-GB进行中（未招募）不适用
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
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
- •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.
研究者
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A comparison of the clinical efficacies of Intense Pulsed Light (IPL), PhotoDynamic Therapy (PDT) and adapalene in the treatment of mild to moderate acne vulgarisAcneISRCTN52474223Cardiff University (UK)37
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