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

NCT05186246 | Unknown Phase 1

• 1 other identifier: EffectivityCombiSpentGrain
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne Vulgaris

Keywords

laser; cream; fractional co2 laser; spent wax

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

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

Drug: Combination cream

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.

Drug: Placebo cream

Interventions

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.

Experimental Combination Cream Group

Placebo cream DRUG

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

Placebo comparator

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr.dr.Irma Bernadette, SpKK (K): lead

Study Sites (1)

Rumah Sakit Angkatan Darat Gatot Soebroto

Jakarta, DKI Jakarta, 10410, Indonesia

RECRUITING

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Lidocaine, Prilocaine Drug Combination

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Lidocaine; Acetanilides; Anilides; Amides; Organic Chemicals; Prilocaine; Aniline Compounds; Amines; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Irma BS Sitohang, MD

  Fakultas Kedokteran Universitas Indonesia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Irma BS Sitohang, MD

CONTACT

+62818130761; irma_bernadette@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. dr. Irma Bernadette S. Sitohang, SpKK(K) - Head of Cosmetic Dermatology Division of Dermatology and Venereology Department of Faculty of Medicine Universitas Indonesia / Cipto Mangunkusumo Hospital

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: January 11, 2022
• Study Start: December 20, 2021
• Primary Completion: January 31, 2022
• Study Completion: February 28, 2022
• Last Updated: January 11, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)