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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Combination Cream Group | Experimental | 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 |
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| Placebo comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combination cream | Drug | 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Irma BS Sitohang, MD | Contact | +62818130761 | irma_bernadette@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Irma BS Sitohang, MD | Fakultas Kedokteran Universitas Indonesia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rumah Sakit Angkatan Darat Gatot Soebroto | Recruiting | Jakarta | DKI Jakarta | 10410 | Indonesia |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| D000077442 | Lidocaine, Prilocaine Drug Combination |
| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 |
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| Placebo cream | Drug | Cream that is identical looking were given to subjects to be applied on the other side of the face twice daily |
|
| Organic Chemicals |
| D011318 | Prilocaine |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |