The safety and efficacy of Fractional CO2 laser with topical insulin versus Fractional CO2 laser alone in facial atrophic post-acne scar: A randomized split-face study
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To Compare the efficacy of topical insulin with fractional CO2 laser versus fractional CO2 alone in the treatment of PAS.
研究概览
简要总结
This is a randomized split-face study that includes 30 atrophic post-acne scar patients meeting the inclusion and exclusion criteria, visiting the IMS and SUM Hospitals skin VD OPD. On each visit, pre- and post-procedure photographs along with grading of acne scars are done, and fractional CO2 with topical insulin on one side of the face is given, decided by computer-generated randomization, and fractional CO2 laser with topical normal saline is given on the other side of the face. Pre and post-procedure blood sugar levels are recorded, and post-procedure erythema and post-inflammatory hyperpigmentation scores are done on each visit
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Atrophic post Acne scar of any grade Fitzpatrick skin type 3 to 6 No treatment (including surgical and laser therapy) within 12 weeks before being enrolled in the study.
排除标准
- •Pregnancy and lactation Autoimmune disease, connective tissue disease History of Photosensitivity Use of immunosuppressive medications, active cancer, underlying illness (cardiac, neurological) History of skin cancers, and presence of premalignant or malignant cutaneous lesions over the face.
- •History of keloidal tendency Patient on isotretinoin therapy Presence of hypertrophic scars History of diabetes mellitus.
结局指标
主要结局
To Compare the efficacy of topical insulin with fractional CO2 laser versus fractional CO2 alone in the treatment of PAS.
时间窗: 0 week,4 weeks,8 weeks,12 weeks
次要结局
- To Assess the safety of topical insulin with fractional CO2 laser in the treatment of PAS.(To Assess the effect of topical insulin with fractional CO2 laser therapy on the quality of life in PAS patients)