The Effectiveness and Safety of Cleanser Containing Triethyl Citrate, Pyruvic Acid, Combination Cream Containing Triethyl Citrate, Ethyl Linoleate, GT Peptide-10, Salicylic Acid 0,5%, Zinc Lactate, Hyaluronic Acid and Spot Cream Containing Triethyl Citrate, Ethyl Linoleate, GT Peptide-10, Honokiol

January 14, 2025 updated by: Dr.dr.Irma Bernadette, SpKK (K)

The Effectiveness and Safety of Cleanser Containing Triethyl Citrate, Pyruvic Acid, Combination Cream Containing Triethyl Citrate, Ethyl Linoleate, GT Peptide-10, Salicylic Acid 0,5%, Zinc Lactate, Hyaluronic Acid and Spot Cream Containing Triethyl Citrate, Ethyl Linoleate, GT Peptide-10, Honokiol As Adjuvant Therapy for Mild to Moderate Acne Vulgaris

The goal of this clinical study is to learn the effectiveness and safety of Cleanser containing Triethyl citrate, Pyruvic acid, Combination cream containing Triethyl citrate, Ethyl linoleate, GT peptide-10, Salicylic acid 0,5%, Zinc lactate, Hyaluronic acid and Spot cream containing Triethyl citrate, Ethyl linoleate, GT peptide-10, Honokiol as Adjuvant Therapy for Mild to Moderate Acne Vulgaris. This research aims to answer the main questions, those are :

  1. How is the effectiveness of Cleanser containing Triethyl citrate, Pyruvic acid, Combination cream containing Triethyl citrate, Ethyl linoleate, GT peptide-10, Salicylic acid 0,5%, Zinc lactate, Hyaluronic acid and Spot cream containing Triethyl citrate, Ethyl linoleate, GT peptide-10, Honokiol as Adjuvant Therapy for Mild to Moderate Acne Vulgaris?
  2. How is the safety of Cleanser containing Triethyl citrate, Pyruvic acid, Combination cream containing Triethyl citrate, Ethyl linoleate, GT peptide-10, Salicylic acid 0,5%, Zinc lactate, Hyaluronic acid and Spot cream containing Triethyl citrate, Ethyl linoleate, GT peptide-10, Honokiol as Adjuvant Therapy for Mild to Moderate Acne Vulgaris?

Participants are males and females between 15-50 years old. Participants will be examined by dermatologist, and will be photographed in five different positions, and also evaluated by janus facial analysis system. The participants are asked to use Cleanser containing Triethyl citrate, Pyruvic acid, Combination cream containing Triethyl citrate, Ethyl linoleate, GT peptide-10, Salicylic acid 0,5%, Zinc lactate, Hyaluronic acid and Spot cream containing Triethyl citrate, Ethyl linoleate, GT peptide-10, Honokiol as Adjuvant Therapy. The participants will be evaluated in 28, 56 and 84 days after the treatment.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a clinical study with randomized controlled trial design to learn the effectiveness and safety of Cleanser containing Triethyl citrate, Pyruvic acid, Combination cream containing Triethyl citrate, Ethyl linoleate, GT peptide-10, Salicylic acid 0,5%, Zinc lactate, Hyaluronic acid and Spot cream containing Triethyl citrate, Ethyl linoleate, GT peptide-10, Honokiol as Adjuvant Therapy for Mild to Moderate Acne Vulgaris. This study will be conducted in three Dermatology and Venereology Education Centers in Indonesia located in Jakarta (Rumah Sakit Pusat Angkatan Darat Gatot Soebroto), Padang (Rumah Sakit Umum Pusat Dr. M. Djamil), Bali (Rumah Sakit Umum Pusat Prof. Dr. I.G.N.G Ngoerah). Group 1 will receive placebo cleanser, placebo combination cream, and placebo spot cream every morning and evening, and then placebo cleanser, placebo combination cream and adapalene 0,1% every night. Group 2 will receive cleanser, containing Triethyl citrate, Pyruvic acid, combination cream, containing Triethyl citrate, Ethyl linoleate, GT peptide-10, Salicylic Acid 0,5%, Zinc Lactate, Hyaluronic acid, and spot cream, containing Triethyl citrate, Ethyl linoleate, GT peptide-10, Honokiol, every morning and evening, and then cleanser, containing Triethyl citrate, Pyruvic acid, combination cream, containing Triethyl citrate, Ethyl linoleate, GT peptide-10, Salicylic Acid 0,5%, Zinc Lactate, Hyaluronic acid, and adapalene 0,1% cream every night. All participant will be evaluated in day 28, 56, and 84. Therapy evaluation will be assessed by dermatologist based on the Global Acne Severity Scale (GEA Score), Indonesia Acne Expert Meeting (IAEM Score), Clinician Erythema Assessment (CEA), Total of Inflammation and Non-Inflammation lesions, Acne Sequelae, facial skin analysis with Janus Skin Facial Analysis, and evaluation of quality of life using Acne-Quality of Life (Acne-QoL).

Study Type

Interventional

Enrollment (Estimated)

102

Phase

  • Phase 3

Contacts and Locations

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

Study Contact

  • Name: Prof. Dr. dr. Irma Bernadette, Sp.DVE, Subsp. D.K.E Sitohang
  • Phone Number: +62818130761
  • Email: irma_bernadette@yahoo.com

Study Contact Backup

Study Locations

  • Indonesia
    • Jakarta Pusat
      • Jakarta, Jakarta Pusat, Indonesia, 10410
        • Rumah Sakit Pusat Angkatan Darat Gatot Soebroto
        • Contact:
        • Contact:

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

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Female and male aged 15-50 years
  • mild to moderate acne vulgaris according to IAEM (Indonesian Acne Expert Meeting) scale and GEA ( Global Acne Severity) scale
  • The subject is willing to participate in the study until it is finished

Exclusion Criteria:

  • History of allergy to dermocosmetic products
  • Undergoing other acne therapy, medication, or invasive action in the last month
  • Pregnant or breastfeeding subjects

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
this arm will receive placebo cleanser, placebo combination cream, and placebo spot cream every morning and evening, and then placebo cleanser, placebo combination cream and adapalene 0,1% every night
Drug: Adapalene 0,1% cream
adapalene 0.1% cream will be given to subjects to be applied every night in group 1 and 2
Drug: placebo cleanser
placebo cleanser will be given to subjects to be applied every morning, evening and night in group 1
Drug: placebo cream combination
placebo cream combination will be given to subjects to be applied every morning, evening and night in group 1
Drug: placebo spot cream
placebo spot cream will be given to subjects to be applied every morning and evening in group 1
Active Comparator: Treatment
this arm will receive cleanser, containing Triethyl citrate, Pyruvic acid, combination cream, containing Triethyl citrate, Ethyl linoleate, GT peptide-10, Salicylic Acid 0,5%, Zinc Lactate, Hyaluronic acid, and spot cream, containing Triethyl citrate, Ethyl linoleate, GT peptide-10, Honokiol, every morning and evening, and then cleanser, containing Triethyl citrate, Pyruvic acid, combination cream, containing Triethyl citrate, Ethyl linoleate, GT peptide-10, Salicylic Acid 0,5%, Zinc Lactate, Hyaluronic acid, and adapalene 0,1% cream every night
Drug: Adapalene 0,1% cream
adapalene 0.1% cream will be given to subjects to be applied every night in group 1 and 2
Drug: Cleanser
Cleanser consist of Triethyl citrate and Pyruvic acid, will be given to subjects to be applied every morning, evening and night in group 2
Drug: Combination cream
combination cream consist of Triethyl citrate, Ethyl linoleate, GT peptide-10, Salicylic Acid 0,5%, Zinc Lactate, Hyaluronic acid will be given to subjects to be applied every morning, evening and night in group 2
Drug: spot cream
spot cream consist of Triethyl citrate, Ethyl linoleate, GT peptide-10, Honokiol, will be given to subjects to be applied every morning and evening in group 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of acne severity
Time Frame: Re-evaluation on day 28, 56 and 84 of therapy
Based on global acne severity scale (GEA score). On a scale of 0-5, 0 indicates no lesion, while 5 indicates very severy acne
Re-evaluation on day 28, 56 and 84 of therapy
Change of acne severity
Time Frame: Re-evaluation on day 28, 56 and 84 of therapy
Based on Indonesia Acne Expert Meeting scale (IAEM scale). the scale consists of mild, moderate and severe.
Re-evaluation on day 28, 56 and 84 of therapy
total of inflammation lesion and non inflammation lesion
Time Frame: Re-evaluation on day 28, 56 and 84 of therapy
The total lesion will be examined by dermatologist
Re-evaluation on day 28, 56 and 84 of therapy
acne sequelae
Time Frame: Re-evaluation on day 28, 56 and 84 of therapy
The acne sequelae will be examined by dermatologist
Re-evaluation on day 28, 56 and 84 of therapy
Quality of life
Time Frame: Re-evaluation on day 28, 56 and 84 of therapy
Based on acne quality of life (Acne-QoL). Total score of acne-QoL is 0-114, the higher score interprets better quality of life of acne vulgaris patient
Re-evaluation on day 28, 56 and 84 of therapy
Erythema severity
Time Frame: Re-evaluation on day 28, 56 and 84 of therapy
based on clinician erythema assessment scale (CEA scale). on the scale of 0-4. 0 indicates no erythema, while 4 indicates severe erythema
Re-evaluation on day 28, 56 and 84 of therapy
Facial analysis
Time Frame: Re-evaluation on day 28, 56 and 84 of therapy
The facial analysis will be done by using janus facial analysis system
Re-evaluation on day 28, 56 and 84 of therapy

Collaborators and Investigators

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

Sponsor

Dr.dr.Irma Bernadette, SpKK (K)

Collaborators

Indonesian Medical Education and Research Institute
Indonesian Society of Dermatology and Venereology
College of Dermatologist and Venereologist

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 (Estimated)

March 1, 2025

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

January 13, 2025

First Submitted That Met QC Criteria

January 13, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 14, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AKNICARE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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