Trial of Methyl Aminolevulinate Plus Aktilite in Facial Photodamage
关键词
抽象
描述
It has been demonstrated that photodamage leads to wrinkles, mottled pigmentation, lentigines, telangiectasias, and textural changes, but more importantly, it can also lead to pre-cancerous conditions with the development of actinic keratosis (AK). The majority of photorejuvenation or photodamaged published studies have used 5-Amino-Levulinic acid (5-ALA) as a photosensitizer, and either a blue light or an Intense Pulsed Light source with a 70%-95% global facial skin improvement. The molecular mechanism of such improvement is unknown, but activation of a non-specific immune response in addition to increased fibrosis and new collagen formation, have both been suggested.
Methyl Aminolevulinate ( MAL) is another marketed photosensitizer mainly utilized in Europe. Lipophilicity, higher penetration depth and tumor selectivity has been advocated for MAL compared to 5-ALA. However, its effect in photodamaged skin has not been well documented.
The aim of the study is to determine the efficacy of MAL + Aktilite (PDT) in facial photodamage.
Study Type: Interventional
Study Design: Randomized, double-Blind, placebo-controlled trial. Official Title: A randomized, double-Blind, placebo-controlled trial of Methyl Aminolevulinate + Aktilite in patients with facial photodamage.
日期
| 最后验证: | 02/28/2009 |
| 首次提交: | 02/24/2008 |
| 提交的预估入学人数: | 03/03/2008 |
| 首次发布: | 03/05/2008 |
| 上次提交的更新: | 03/12/2009 |
| 最近更新发布: | 03/15/2009 |
| 实际学习开始日期: | 01/31/2008 |
| 预计主要完成日期: | 12/31/2008 |
| 预计完成日期: | 02/28/2009 |
状况或疾病
干预/治疗
Other: B
Drug: A
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Active Comparator: A | Drug: A Methyl Aminolevulinate cream for 3 hours before Photodynamic therapy ( Aktilite) |
| Placebo Comparator: B | Other: B Cetaphil cream(For 3 hours) + Aktilite ( Photodynamic Therapy for 8 minutes) |
资格标准
| 有资格学习的年龄 | 35 Years 至 35 Years |
| 有资格学习的性别 | Female |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Female subjects older than 35 years of age and less than 75 years of age - Subjects with a photodamage grade of 2 or 3 according to a modified Dover´s Global photodamage scale - Subjects willing to participate according to protocol requirements. - Patients with signed Informed Consent - Patients with no exclusion criteria Exclusion Criteria: - Pregnant or nursing females. - Subjects with suspected porphyria, Systemic or cutaneous erythematosus lupus, or any other photosensitizing disorder or drug induced photosensitization. - Any active infectious skin disorder ( Herpes simplex, molluscum contagiosum, facial warts ) - Subjects with less than 6 months of previous rejuvenation interfering treatments - Subjects requiring concurrent treatment that would interfere with study objectives and/or assessments. |
结果
主要结果指标
1. Efficacy in facial global photodamage [8 months]
次要成果指标
1. Facial fine lines, mottled pigmentation, tactile roughness, sallowness, erythema, telangiectasia [12 months]
2. Histological effect of MAL+PDT in fibrosis and new collagen formation [12 months]
3. Safety and tolerance [12 months]
