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Not yet recruiting NCT06775314

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

Phase III Interventional Acne Vulgaris

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cleanser, Combination cream, spot cream, Adapalene 0,1% cream.
Who it may be relevant to
Registry conditions: Acne Vulgaris. Basic parameters: 15 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Indonesia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

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).

Interventions

  • 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
  • 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

Primary outcome measures

  • Change of acne severity [Time frame: 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]
  • total of inflammation lesion and non inflammation lesion [Time frame: Re-evaluation on day 28, 56 and 84 of therapy]
  • acne sequelae [Time frame: 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]
  • Erythema severity [Time frame: Re-evaluation on day 28, 56 and 84 of therapy]
  • Facial analysis [Time frame: Re-evaluation on day 28, 56 and 84 of therapy]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Indonesia · 1 center
  • Rumah Sakit Pusat Angkatan Darat Gatot Soebroto — Jakarta

Identifiers

NCT: NCT06775314 · AKNICARE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗