Effectivity and Safety of Combination of Spent Grain Wax, Argan Oil, Shea Butter and Saccharide Isomerate

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effectivity and Safety of Combination of Spent Grain Wax, Argan Oil, Shea Butter and Saccharide Isomerate Post Fractional CO2 Laser

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: Combination cream
* Drug: Placebo cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Combination Cream Group<br>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 | Drug: Combination cream<br>* Spent Grain Wax, Argan Oil, Shea Butter and Saccharide Isomerate Cream combination (10 gram), were applied on one side of the face twice daily by participants.<br>|
| Placebo Comparator: Placebo comparator<br>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. | Drug: Placebo cream<br>* Cream that is identical looking were given to subjects to be applied on the other side of the face twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Eryhtema Score | Based on Clinical Erythema Assessment Scale. Scale range is 0-4, 0 indicates no erythema and 4 indicates severe erythema | baseline; 3 days post fractional CO2 laser; and 7 days post fractional CO2 laser | 
| Change of Photoaging Skin Condition | 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. | baseline; 3 days post fractional CO2 laser; and 7 days post fractional CO2 laser | 
| Change of Subjective Pain Evaluation | Assessed using Visual Analog Scale (VAS). Scale range is 0-10, 0 indicates no pain and 10 indicates severe pain | baseline; 3 days post fractional CO2 laser; and 7 days post fractional CO2 laser | 
| Change of Skin Capacitance | Assessed using TEWAmeter to see changes in Skin Capacitance | baseline; 3 days post fractional CO2 laser; and 7 days post fractional CO2 laser | 
| Change of Skin Conditions of patients assessed by Janus Facial Analysis System | 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 | baseline; 3 days post fractional CO2 laser; and 7 days post fractional CO2 laser | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laser, cream, fractional co2 laser, spent wax