Clinical and Histological Analysis of Photoaging Treatment With Imiquimod Cream 5%
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Evaluation of clinical response by percentage of improvement
研究概览
简要总结
Recently it was demonstrated that imiquimod in addition to exerting a repairing effect in pre malignant and malignant lesions caused by UV radiation it reverses histopathological changes associated with the photoaging skin.
This is an experimental exploratory study. It included 17 patients. The patients were diagnosed with photoaging grades III and IV in the scale of Glogau and volunteered to participate in the study. Patients were treated with imiquimod 5% topically, for a time period of 12 weeks. Biopsies were taken from periorbital skin area at baseline and after 4 weeks after completing the treatment. Adverse effects, adherence to therapy and patients' satisfaction were measured.
Clinical and histological parameters of photoaging were studied at baseline and after treatment. After completion of treatment with imiquimod, the final clinical evaluation was compared to the initial one.
详细描述
An experimental study was conducted between July and November 2010 in order to evaluate the efficacy and safety of imiquimod as a treatment option for photoaging.
The sample population was made up of individuals from both genders, older than 40 years, who worked at a flower growing farm located in a rural area of Rionegro (Antioquia) with an altitude of 2,125 meters above sea level; approximately composed of 80 people.
The sample size was calculated considering improvements in 50% or more of patients had to be detected, with a confidence interval of 95%, a power of 80%, a sampling error of 5%.
There were five visits: one at baseline and at months 1, 2, 3 and 4. In each visit patients were assesed clinically, a photograph was taken and adherence and side effects were investigated. Treatment was given during the first 3 months. A biopsy was taken at baseline and during the 4th month assessment. The last visit for clinical monitoring, photographic follow up and skin biopsy was at 16 weeks (4 weeks after discontinuation of the medication). In this last visit patient's satisfaction was evaluated through a survey.
The clinical assessment of photodamage performed by two dermatologists independently included: Changes in texture: dryness/roughness; changes in color: mottled hyperpigmentation, lentigines, yellowing; wrinkles: fine, deep wrinkles and laxity; telangiectasias.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients with Fitzpatrick's skin types I to IV, with a photoaging equal to or greater than 3 on the Glogau measuring scale, who had not used systemic retinoids for over four weeks during six months prior to baseline,
- •Patients nor had they undergone chemical peels or used exfoliants or applied botulinum toxin or any other abrasive substance on the face six months prior baseline
- •patients that had not used topical retinoids or steroids two months prior to baseline
- •patients that had not undergone facial rejuvenation surgery 12 months prior to treatment.
排除标准
- •pregnant or nursing women
- •patients currently being treated with phototherapy
- •patients currently being treated with photochemotherapy or whom were scheduled to start
- •patients with suspected skin cancer assessed by clinical examination
- •patients with dermatological conditions with changes in the texture or color of the skin
- •Patients with inflammatory dermatoses, immunological, infectious, or neoplastic skin diseases located in the periocular area since it could interfere with the clinical assessment of photoaging.
- •Patients that at the time of inclusion expressed treatment refusal, disinterest or inability to comply with the protocol as well as those with skin types V and VI were not included.
研究组 & 干预措施
imiquimod use in photoaging
Evaluate the efficacy and safety of imiquimod as a treatment option for photoaging photoaging equal to or greater than 3.
干预措施: Imiquimod (Drug)
结局指标
主要结局
Evaluation of clinical response by percentage of improvement
时间窗: 8 weeks
To determine the degree of patient improvement percentages were set according to the values obtained in the first and last measurement as follows: For ordinal clinical variables that had 4 categories the following percentages were established: Slight 1-point improvement (1-32%), moderate 2-point improvement (33-66%), good 3-point improvement (\> 66%), same or worse, one or more points of deterioration (\<= 0%). For ordinal histological variables that were 4 categories the calculated improvement percentages were equal to the ones just described and for those with 5 variables, the established percentages were as follows: Slight 1-point improvement (1-25%), moderate 2-point improvement (26-50%), good 3-point improvement (51-75%), excellent 4-point improvement (\> 75%), one or more points of deterioration (\<= 0%).
次要结局
未报告次要终点
研究者
Sol Beatriz Jiménez
Researcher
CES University