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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
20
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.
Cream that is identical looking were given to subjects to be applied on the other side of the face twice daily
Rumah Sakit Angkatan Darat Gatot Soebroto
Jakarta, DKI Jakarta, Indonesia
RECRUITINGChange of Eryhtema Score
Based on Clinical Erythema Assessment Scale. Scale range is 0-4, 0 indicates no erythema and 4 indicates severe erythema
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: baseline; 3 days post fractional CO2 laser; and 7 days post fractional CO2 laser
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