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

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Primary Purpose

Status

Recruiting

Phase

Phase 1

Locations

Indonesia

Study Type

Interventional

Intervention

Combination cream

Placebo cream

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring laser, cream, fractional co2 laser, spent wax

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Rumah Sakit Angkatan Darat Gatot SoebrotoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental Combination Cream Group

Placebo comparator

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Change of Eryhtema Score

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

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

Assessed using Visual Analog Scale (VAS). Scale range is 0-10, 0 indicates no pain and 10 indicates severe pain

Change of Skin Capacitance

Assessed using TEWAmeter to see changes in Skin Capacitance

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05186246

First Posted

December 13, 2021

Last Updated

January 6, 2022

Sponsor

Dr.dr.Irma Bernadette, SpKK (K)

1. Study Identification

Unique Protocol Identification Number

NCT05186246

Brief Title

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

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Recruiting

Study Start Date

December 20, 2021 (Actual)

Primary Completion Date

January 31, 2022 (Anticipated)

Study Completion Date

February 28, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Dr.dr.Irma Bernadette, SpKK (K)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acne Vulgaris

Keywords

laser, cream, fractional co2 laser, spent wax

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental Combination Cream Group

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo comparator

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Combination cream

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo cream

Intervention Description

Cream that is identical looking were given to subjects to be applied on the other side of the face twice daily

Primary Outcome Measure Information:

Title

Change of Eryhtema Score

Description

Based on Clinical Erythema Assessment Scale. Scale range is 0-4, 0 indicates no erythema and 4 indicates severe erythema

Time Frame