Acne Vulgaris
Conditions
Keywords
laser, cream, fractional co2 laser, spent wax
Brief summary
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
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.
Interventions
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.
DRUGPlacebo cream
Cream that is identical looking were given to subjects to be applied on the other side of the face twice daily
Sponsors
Dr.dr.Irma Bernadette, SpKK (K)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Eryhtema Score | 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 Photoaging Skin Condition | 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 Subjective Pain Evaluation | 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 | 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 | 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 |
Countries
Indonesia
Contacts
Primary ContactIrma BS Sitohang, MD
Outcome results
None listed