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

NCT ID: NCT06775314

Last Updated: 2025-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-01

Study Completion Date

2025-06-30

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Acne Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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

Group Type PLACEBO_COMPARATOR

Adapalene 0,1% cream

Intervention Type DRUG

adapalene 0.1% cream will be given to subjects to be applied every night in group 1 and 2

placebo cleanser

Intervention Type DRUG

placebo cleanser will be given to subjects to be applied every morning, evening and night in group 1

placebo cream combination

Intervention Type DRUG

placebo cream combination will be given to subjects to be applied every morning, evening and night in group 1

placebo spot cream

Intervention Type DRUG

placebo spot cream will be given to subjects to be applied every morning and evening in group 1

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

Group Type ACTIVE_COMPARATOR

Cleanser

Intervention Type DRUG

Cleanser consist of Triethyl citrate and Pyruvic acid, will be given to subjects to be applied every morning, evening and night in group 2

Combination cream

Intervention Type DRUG

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

spot cream

Intervention Type DRUG

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

Adapalene 0,1% cream

Intervention Type DRUG

adapalene 0.1% cream will be given to subjects to be applied every night in group 1 and 2

Interventions

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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

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

Adapalene 0,1% cream

adapalene 0.1% cream will be given to subjects to be applied every night in group 1 and 2

Intervention Type DRUG

placebo cleanser

placebo cleanser will be given to subjects to be applied every morning, evening and night in group 1

Intervention Type DRUG

placebo cream combination

placebo cream combination will be given to subjects to be applied every morning, evening and night in group 1

Intervention Type DRUG

placebo spot cream

placebo spot cream will be given to subjects to be applied every morning and evening in group 1

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indonesian Society of Dermatology and Venereology

UNKNOWN

Sponsor Role collaborator

College of Dermatologist and Venereologist

UNKNOWN

Sponsor Role collaborator

Indonesia Medical Education and Research Institute

OTHER

Sponsor Role collaborator

Dr.dr.Irma Bernadette, SpKK (K)

OTHER

Sponsor Role lead

Responsible Party

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Dr.dr.Irma Bernadette, SpKK (K)

Prof. Dr. dr. Irma Bernadette, Sp.DVE, Subsp. D.K.E

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Rumah Sakit Pusat Angkatan Darat Gatot Soebroto

Jakarta, Jakarta Pusat, Indonesia

Site Status

Countries

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Indonesia

Central Contacts

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Prof. Dr. dr. Irma Bernadette, Sp.DVE, Subsp. D.K.E Sitohang

Role: CONTACT

+62818130761

dr. Lilik Norawati, Sp.DVE

Role: CONTACT

+628121107149

Facility Contacts

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Prof. Dr. dr. Irma Bernadette, Sp.DVE, Subsp. D.K.E

Role: primary

+62818130761

dr. Lilik Norawati, Sp.DVE

Role: backup

+628121107149

Other Identifiers

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AKNICARE

Identifier Type: -

Identifier Source: org_study_id

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