Clinical trial NCT05186246: Effectivity and Safety of Combination of Spent Grain Wax, Argan Oil, Shea Butter and Saccharide Isomerate
Official title: Effectivity and Safety of Combination of Spent Grain Wax, Argan Oil, Shea Butter and Saccharide Isomerate Post Fractional CO2 Laser
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Acne Vulgaris
Keywords: laser
cream
fractional co2 laser
spent wax
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of Eryhtema Score
timeFrame: baseline; 3 days post fractional CO2 laser; and 7 days post fractional CO2 laser
measure: Change of Photoaging Skin Condition
timeFrame: baseline; 3 days post fractional CO2 laser; and 7 days post fractional CO2 laser
measure: Change of Subjective Pain Evaluation
timeFrame: baseline; 3 days post fractional CO2 laser; and 7 days post fractional CO2 laser
measure: Change of Skin Capacitance
timeFrame: baseline; 3 days post fractional CO2 laser; and 7 days post fractional CO2 laser
measure: Change of Skin Conditions of patients assessed by Janus Facial Analysis System
timeFrame: baseline; 3 days post fractional CO2 laser; and 7 days post fractional CO2 laser
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Rumah Sakit Angkatan Darat Gatot Soebroto
state: DKI Jakarta
Study officials:
affiliation: Fakultas Kedokteran Universitas Indonesia
name: Irma BS Sitohang, MD
role: PRINCIPAL_INVESTIGATOR
References: