NCT00975312已完成2 期
Solar Lentigines Treatment With the Triple Combination Cream (Hydroquinone 4%, Tretinoin 0.05%, and Fluocinolone Acetonide 0.01%). Randomized, Double Blind, Controlled Trial.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Target lesion pigmentation becomes equal or slightly darker than the surrounding skin
研究概览
简要总结
Background
- Lentigines are usually the first sign of photoaging and may produce a significant impact on patients' quality of life.
- There is no a treatment of choice for this condition.
- Solar lentigines and melasma share similar physiopathologic characteristics.
- The triple combination (TC) cream (hydroquinone 4%, tretinoin 0.05%, and fluocinolone acetonide 0.01%) has been effective and safe for the treatment of melasma and other hyperpigmented lesions.
Hypothesis
* The TC cream will be effective and safe for the treatment of solar lentigines on the back of the hands.
Patients and methods
- 22 patients with solar lentigines were selected and their right hand or left hand were selected at random to be treated with either TC cream or tretinoin 0.05% cream once daily for up 12 weeks.
- Patients were instructed to apply both creams on the whole back of the hand and not only in the lentigines, and to use a broad-spectrum sunscreen (SPF 50+, UVA-PF 28) daily in both hands.
- Clinical assessments of Target Lesion Pigmentation, Physician's Global Assessment of Improvement and a Subject's Self-Assessment questionnaire were collected for data analysis at weeks 4, 8, and 12 after starting the treatment and 3 month post-treatment.
- Statistical methods: The ordinally scaled efficacy measures underwent rank transformation and were analyzed by analysis of variance to test the null hypothesis of no differences among treatments. We performed Mann-Whitney and Wilcoxon tests and the XLSTAT 2009 software was used.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 30 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects of both sexes of 30 - 80 years of age.
- •Phototype II-V.
- •Postmenopausal women of childbearing age or users of any contraception method with negative pregnancy test (beta subunit chorionic gonadotropin in the blood) at baseline and that maintain the contraceptive treatment during the investigation.
- •Subjects with more than 10 solar lentigines on the back of each hand wich were no treated in the last 6 months
排除标准
- •Patients under 30 or over 80 years of age.
- •Skin types I and VI.
- •Less than 10 solar lentigines on the back of each hand.
- •Patients who have received or are receiving any other treatment for lentigines of the back of hands.
- •Women of childbearing age without contraceptive therapy.
- •Pregnancy or lactation.
- •History of hypersensitivity to any component of the drugs.
- •Simultaneous use of other topical skin lightening.
- •Patient refusal to participate in the study.
研究组 & 干预措施
Triple combination cream
Experimental
The triple combination cream (hydroquinone 4%, tretinoin 0.05%, and fluocinolone acetonide 0.01%) was applied on the whole back of one hand.
干预措施: Triple combination cream (Drug)
Triple combination cream
Experimental
The triple combination cream (hydroquinone 4%, tretinoin 0.05%, and fluocinolone acetonide 0.01%) was applied on the whole back of one hand.
干预措施: Tretinoin 0.05% (Drug)
结局指标
主要结局
Target lesion pigmentation becomes equal or slightly darker than the surrounding skin
时间窗: 3 months
次要结局
- Improvement in physician's global assessment(3 months)
研究者
研究点 (1)
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