Effectivity and Safety of Combination of Spent Grain Wax, Argan Oil, Shea Butter and Saccharide Isomerate Post Fractional CO2 Laser
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change of Photoaging Skin Condition
研究概览
简要总结
The clinical study will compare the efficacy and safety of Combination of Spent Grain Wax, Argan Oil, Shea Butter and Saccharide Isomerate cream post fractional CO2 laser. Combination of Spent Grain Wax, Argan Oil, and Shea Butter was formulated to reduce skin irritation and allergy symptoms such as dryness, itch and rash. The combination cream applied on one side of the face while placebo will be applied on the other side of the face in 18-60 years old female post fractional CO2 laser.
详细描述
This study is an experimental study with a randomized controlled trial (RCT) design on patients who met the inclusion criteria. All participants will receive pretreatment in the form of 0.05% tretinoin cream for two weeks, then all participants will undergo fractional CO2 laser treatment. Post laser treatment, the participants will be given cream A and B, which already randomized to be applied on to the face. All participants will be evaluated in day 3 and day 7 post fractional CO2 laser. The results of therapy will mainly be assessed based on the Dermoscopic Photoaging Scale (DPAS), as well as visual analog scale (VAS) for subjective symptoms and Clinician Erythema Assessment Scale (CEA) for erythema and Skin Capacitance measured with TEWAmeter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged 18-60 years old with an understanding of all the information given by written consent form
- •Had undergone priming with tretinoin cream 0,05% for 2 weeks pre fractional CO2 laser treatment
排除标准
- •Personal or family history of skin cancer, especially melanoma
- •Consumption of systemic retinoic acid within 3 month of enrollment
- •Use of any topical skin brightening or whitening preparations within 1 month of enrollment
- •Pigmentary disorders or any dermatoses, which may affect the measurement within the study areas
- •A pregnant or breastfeeding mother
- •History of hormonal or endocrine diseases or taking medication for hormonal or endocrine diseases
- •Inability to comply research protocols
研究组 & 干预措施
Experimental Combination Cream Group
Subjects were randomized to have combination cream to be applied on one side of the face twice daily post fractional CO2 laser. The subjects were evaluated on day 3 and day 7 post fractional CO2 laser. Combination cream consisted of Spent Grain Wax, Argan Oil, Shea Butter and Saccharide Isomerate cream
干预措施: Combination cream (Drug)
Placebo comparator
Subjects were randomized to have placebo cream to be applied on the other side of the face twice daily post fractional CO2 laser. Placebo cream were packaged in identical-looking containers with combination cream. The subjects were evaluated on day 3 and day 7 post fractional CO2 laser.
干预措施: Placebo cream (Drug)
结局指标
主要结局
Change of Photoaging Skin Condition
时间窗: baseline; 3 days post fractional CO2 laser; and 7 days post fractional CO2 laser
This DPAS assessment is based on yes or no rules on 11 criteria in four facial regions, namely left malar, right malar, forehead, and chin. The criteria were yellowish discoloration, white line, lentigo, hypo- and hyper-pigmented macules, telangiectasia, yellow papules, actinic keratosis, senile comedones, deep wrinkle, superficial wrinkle, and criss-cross wrinkle. Score range is 0-44 points.
Change of Eryhtema Score
时间窗: baseline; 3 days post fractional CO2 laser; and 7 days post fractional CO2 laser
Based on Clinical Erythema Assessment Scale. Scale range is 0-4, 0 indicates no erythema and 4 indicates severe erythema
Change of Subjective Pain Evaluation
时间窗: baseline; 3 days post fractional CO2 laser; and 7 days post fractional CO2 laser
Assessed using Visual Analog Scale (VAS). Scale range is 0-10, 0 indicates no pain and 10 indicates severe pain
Change of Skin Capacitance
时间窗: baseline; 3 days post fractional CO2 laser; and 7 days post fractional CO2 laser
Assessed using TEWAmeter to see changes in Skin Capacitance
Change of Skin Conditions of patients assessed by Janus Facial Analysis System
时间窗: baseline; 3 days post fractional CO2 laser; and 7 days post fractional CO2 laser
Assessed using Janus Facial Analysis System® Skin will be assessed using Janus with three different wavelength of light which are normal, polarized and UV light. The skin will be analyzed for pores, wrinkles, sebum and skin tone
次要结局
未报告次要终点
研究者
Dr.dr.Irma Bernadette, SpKK (K)
Dr. dr. Irma Bernadette S. Sitohang, SpKK(K) - Head of Cosmetic Dermatology Division of Dermatology and Venereology Department of Faculty of Medicine Universitas Indonesia / Cipto Mangunkusumo Hospital
Indonesia University