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

January 6, 2022 updated by: Dr.dr.Irma Bernadette, SpKK (K)

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta, DKI Jakarta, Indonesia, 10410
        • Recruiting
        • Rumah Sakit Angkatan Darat Gatot Soebroto
        • Principal Investigator:
          • Irma BS Sitohang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Experimental Combination Cream Group
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
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.
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
Cream that is identical looking were given to subjects to be applied on the other side of the face twice daily

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change of Eryhtema Score
Time Frame: 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
baseline; 3 days post fractional CO2 laser; and 7 days post fractional CO2 laser
Change of Photoaging Skin Condition
Time Frame: 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.
baseline; 3 days post fractional CO2 laser; and 7 days post fractional CO2 laser
Change of Subjective Pain Evaluation
Time Frame: 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
baseline; 3 days post fractional CO2 laser; and 7 days post fractional CO2 laser
Change of Skin Capacitance
Time Frame: baseline; 3 days post fractional CO2 laser; and 7 days post fractional CO2 laser
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
Time Frame: 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
baseline; 3 days post fractional CO2 laser; and 7 days post fractional CO2 laser

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dr.dr.Irma Bernadette, SpKK (K)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 20, 2021

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 11, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 11, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EffectivityCombiSpentGrain

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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