NCT05186246

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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Dr.dr.Irma Bernadette, SpKK (K) · Academic / Other
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Combination cream	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.
DRUG	Placebo cream	Cream that is identical looking were given to subjects to be applied on the other side of the face twice daily

Timeline

• Start date: 2021-12-20
• Primary completion: 2022-01-31
• Completion: 2022-02-28
• First posted: 2022-01-11
• Last updated: 2022-01-11

Locations

1 site across 1 country: Indonesia