CTRI/2019/07/020435尚未招募Phase 3 4
Double ARM Randomised Controlled Study Comparing the Efficacy of Platelet Rich Plasma and Local Application of 2% THBG (Alpha Glucoside Derivative of Trihydroxy Benzoic Acid) in Patients with Facial Melasma.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Physician global assessment scale
研究概览
简要总结
Melasma is the most common cause of facial melanosis and is manifested by hyperpigmented macules on the face which become more pronounced after sun exposure
Transforming growth factor Beta 1(TGF B1) is present in Alfa granules of platelets
It is known to decrease melanogenesis via delayed extracellular signal-regulated kinase activation
Thba
Controls NF-kB pathway
Reduces PGE2 expression
Prevents melanin transfer to keratinocytes
Inhibits Tyrosinase
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •patients with age above 18 years irrespective of their sex clinically diagnosed melasma will be included in study .
排除标准
- •Females on oral contraceptive pill Age <18 years Pregnant female Tendency for keloid, hypertrophic scar Bleeding disorder Platelet abnormality On anticoagulant drugs Chronic liver disease On oral tretinoin Refusal to allow photographs hiv/hbsag +ve.
结局指标
主要结局
Physician global assessment scale
时间窗: after 6 weeks
MelasQOL(melasma quality of life)
时间窗: after 6 weeks
dermoscope
时间窗: after 6 weeks
Modified melasma area severity index
时间窗: after 6 weeks
Patients global assessment scale
时间窗: after 6 weeks
次要结局
- dermoscopic and woods lamp dignosis of melasma(improvement in masi and melaqol)
研究者
研究点 (1)
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