ISRCTN52474223已完成未知
Randomised, controlled, double-blind, parallel group clinical trial evaluating the efficacies and safety of methyl-aminolevulinate photodynamic therapy (PDT-MAL) and intense pulsed light, administered as placebo-photodynamic therapy (PDT-placebo), compared with the efficacy of adapalene 0.1% gel in the treatment of adults with mild to moderate acne vulgaris
Cardiff University (UK)0 个研究点目标入组 37 人开始时间: 2008年5月30日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 37
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
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