A RANDOMISED CONTROL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF 15% TRICHLOROACETIC ACID PEEL VERSUS 35% GLYCOLIC ACID PEEL IN PATIENTS WITH CUTANEOUS MACULAR AMYLOIDOSIS.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- IMPROVEMENT IN THE PIGMENTATION OF SKIN.
研究概览
简要总结
After obtaining approval and clearance from the institutional ethics committee, the patients fulfilling the inclusion criteria will be enrolled for the study after obtaining informed consent.
A detailed clinical history will be taken in terms of demographic data, age, sex, occupation, presenting complaints, past history, treatment history, family history duration of skin lesions, course and progression of disease and clinical examination findings will be recorded in the case record form Appropriate photographs will be taken with informed consent.
After detailed history taking and thorough clinical examination, the patients illness will be scored with Color score, Visual Analogue Score (VAS), Physician Global Assessment Scale (PGA) & subjective grade.
Patients diagnosed with Macular amyloidosis will be allocated into two study groups of 24 each randomized in 1:1 ratio using computer random sequence generator.
- Group A patients will be treated with 15% TCA peel. Prepeel priming will be done with GA cream 12% and physical sunscreen for 2 weeks. Test patch with 50% TCA behind the ear will be done in every patient 2weeks prior to peeling. The involved area will be degreased with 70% alcohol and TCA 15% will be applied by cotton bud. After a contact period of 3-5 minutes neutralisation will be done with normal saline. If the patient develops frosting early, it will be neutralized immediately.
- Group B patients will be treated with 35% GA peel. priming will be done with GA cream 12% and physical sunscreen for 2 weeks. involved area will be degreased with 70% alcohol and GA 35% will be applied by cotton bud. After a contact period of 3-5 minutes neutralisation will be done with sodium bicarbonate. If the patient develops erythema early, it will be neutralized immediately.
All groups will receive the treatment and patients’ illness will be reassessed with complete physical examination, Color score, Visual Analogue Score (VAS) ,Physician Global Assessment Scale (PGA) & subjective grade will be assessed at 4 weeks, 8 weeks, 12 weeks & 16 weeks follow up along with simultaneous serial digital photographs and recording of side effects if any.
Common side effects of TCA 15% and GA 35% are erythema, post inflammatory hyper/hypo pigmentation, burning sensation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients willing to give informed consent
- •Adults aged 18-60 years.
- •Diagnosed with primary cutaneous macular amyloidosis.
- •No prior treatment with TCA or GA peels.
排除标准
- •1.Pregnant or lactating women.
- •2.History of hypersensitivity to TCA or GA.
- •3.Presence of other active skin diseases or infections at the site.
- •4.Use of systemic retinoids within the past 6 months.
- •5.History of keloid or hypertrophic scar formation.
结局指标
主要结局
IMPROVEMENT IN THE PIGMENTATION OF SKIN.
时间窗: AT 4WEEKS, 8WEEKS, 12WEEKS AND 16WEEKS.
IMPROVEMENT IN THE SYMPTOMS LIKE PRURITIS.
时间窗: AT 4WEEKS, 8WEEKS, 12WEEKS AND 16WEEKS.
次要结局
- TO RECORD THE ADVERSE REACTIONS TO CHEMICAL PEELS.(EVALUATE PATIENT SATISFACTION WITH TREATMENT.)
研究者
DR RACHANA DOLLI
BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE, BENGALURU, KARNATAKA.