Role of topical application of polyherbal formulation in photodamaged facial skin: An open label study.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- 2.Hyperpigmentation.
研究概览
简要总结
Skin aging is a complexbiological process influenced by a combination of intrinsic and extrinsicfactors. Extrinsic aging is influenced by factors such as smoking, excessivealcohol consumption, poor nutrition, and chronic exposure to the sun. Wrinklingand pigmentary changes are directly associated with photo-aging. Asian skintends to tan more and burn less, which means that chronic UV exposure tends toproduce more pigmentation-related problems. There are several syntheticskincare cosmetics existing in the market to treat premature aging and theyhave so many adverse reactions too. Therefore a cheap, effective and safealternative is needed for the prevention of skin ageing. For the prevention ofskin aging, Unani physicians recommend the use of Jaali, mohammir and Mohsin allon drugs. In which aarad e baqla,aarad e jau, aarad e nakhud, aarad e masoor, tukhm e turb, khardal, haldi andkateera are selected for the study.They have protein, fat, vitamin B complex, vitamin E, Mn, Cu, Zn, etc. as theirmain constituents. These chemical constituents contribute to photoprotection byincreasing epithelialisation, smoothing the skin and stimulating collagensynthesis. The drugs will be given in powder form, Kateera will be powdered separately and mixed into the wholepowder. Subjects will be advised to take 15 gm powder and mix into milk to forma uniform paste then applied it on the face once a day for 2 month. On theother hand control group will be given Tretinoin 0.025% cream & appliedlocally once a day for 2 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 35.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Having fine lines, wrinkles, hyper pigmentation
- •Moderate to advance facial skin aging
- •No known medical condition
- •Subject must sign a written informed consent.
排除标准
- •Subjects who are taking any medication which interfere with the test result.
- •Having history of skin cancer, melanoma , lupus, psoriasis, connective tissue disease.
- •Pregnant or planning pregnancy during study period, lactating, had given birth during the previous 6 months.
- •Acute or chronic allergy or history of hypersensitivity to cosmetics.
- •Smokers, having psychiatric disorder , hormone related and GIT disease.
- •Uncontrolled metabolic illness (e.g. diabetes mellitus, hypertension).
- •Having any skin procedure in previous 6 months (dermabrasion, chemical peel, botulinum toxin type A injection).
- •Subjects using anti aging skin care products.
结局指标
主要结局
2.Hyperpigmentation.
时间窗: 2 month
1.Hydration.
时间窗: 2 month
3.Dullness and roughness.
时间窗: 2 month
4.Coarse wrinkles.
时间窗: 2 month
次要结局
- 1.Fine lines.(2.thickness.)
