Efficacy of Fractional Carbon Dioxide Laser versus topical Tretinoin 0.05 percent gel in the treatment of striae distensae in Indian skin phototypes: A comparative, split-abdomen study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Comparison of pictures for changes in the appearance and also width by dermoscopy assessment at 0 and 16 week .
研究概览
简要总结
Striae distensae (SD) or stretch marks are linear atrophic dermal scars covered with flat atrophic epidermis. This study aims at comparing the efficacy and safety of Fractional CO2 laser alone and in combination with topical Tretinoin 0.05% gel in the treatment of striae distensae in skin of colour Fitzpatrick skin phototypes III, IV, V and VI.
As, there are not many studies that compares fractional CO2 laser versus topical tretinoin 0.05% gel for striae distensae in Indian skin types, our study will be usefull in comparing the efficacy of both these modalities in the treatment of striae distensae.
All patients with SD visting our Dermatology, Venereology and Leprosy/Cosmetic Dermatology OPD seeking treatment for the same will be enrolled in our study after informed consent. Patients will be examined and extent of striae will be assessed. In patients having multiple sites of involvement, the site of maximum cosmetic concern over the abdomen will be selected for intervention. Abdomen will be divided into two halfs keeping the longitudinal midline as the center. The lesions on the side to be treated with Fractional CO2 laser will be randomly selected by using a chit method. The other side will be treated with topical tretinoin 0.05 % gel. The Tretinoin gel will be continued on a daily basis at night. A total of three laser sessions will be done with an interval of 1 month duration. Post procedure white soft paraffin will be recommended for daily application in the morning over the sites of treatment. Patients will be assessed immediately post treatment for any redness, burning, pain or discomfort. They will also be followed up in the subsequent visits for any untoward complications like post inflammatory hyperpigmentation, infection, persistent erythema, ulcers, scarring and keloid formation. Photographs will be taken at baseline, before each session and at the end of 1 month after the last session.
In our study, the Global aesthetic improvement scale will be used for comparing the photographs at baseline with the final photographs 1 month after the last laser session by a single investigator. The patient satisfaction scores will be done 1 month after the last laser procedure. The width of the striae will also be assessed using dermoscopy prior to initiation of treatment and at 1 month after the last session.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 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
- •aged above 18 years and above and willing for participate in the study.
排除标准
- •Pregnant or lactating women.
- •Patients with severe cardiac, brain, liver or kidney failure, Malnutrition.
- •Patients who have been treated in the previous 6 months with lasers or chemical peels.
- •Patients with active infection.
- •History of keloid formation.
- •Patients with autoimmune diseases, Cushing’s syndrome and polycystic ovary syndrome.
- •History of systemic steroid treatment, systemic retinoid therapy.
- •Unable to visit for regular treatment sessions.
结局指标
主要结局
Comparison of pictures for changes in the appearance and also width by dermoscopy assessment at 0 and 16 week .
时间窗: Assessments will be done by comparing at 0 week and at the end of 16 week of the study
次要结局
- change in appearance of stretch marks(at baseline after 4 weeks at 8 weeks & final assessment is at 16 weeks)
研究者
Dr VEENA V T
CHRISTIAN MEDICAL COLLEGE, VELLORE, TAMIL NADU
