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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

ConditionAcne Vulgaris
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age15-50
SponsorDr.dr.Irma Bernadette, SpKK (K)

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

History of allergy to dermocosmetic products

Undergoing other acne therapy, medication, or invasive action in the last month

Pregnant or breastfeeding subjects

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cleanser

    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

    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

    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

    Drug

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

  • placebo cleanser

    Drug

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

  • placebo cream combination

    Drug

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

  • placebo spot cream

    Drug

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

Treatment groups

102 Participants
are divided into 2 treatment groups
Group A: PlaceboPlacebo comparator 4 interventions
Group B: TreatmentActive comparator 4 interventions

Trial outcomes

Primary outcomes

1

Change of acne severity

Based on global acne severity scale (GEA score). On a scale of 0-5, 0 indicates no lesion, while 5 indicates very severy acne

Time frame
Re-evaluation on day 28, 56 and 84 of therapy
2

Change of acne severity

Based on Indonesia Acne Expert Meeting scale (IAEM scale). the scale consists of mild, moderate and severe.

Time frame
Re-evaluation on day 28, 56 and 84 of therapy
3

total of inflammation lesion and non inflammation lesion

The total lesion will be examined by dermatologist

Time frame
Re-evaluation on day 28, 56 and 84 of therapy
4

acne sequelae

The acne sequelae will be examined by dermatologist

Time frame
Re-evaluation on day 28, 56 and 84 of therapy

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dr.dr.Irma Bernadette, SpKK (K)

Lead sponsor

Indonesia University

Sponsor institution

Indonesian Society of Dermatology and Venereology

Collaborator

College of Dermatologist and Venereologist

Collaborator

Indonesia Medical Education and Research Institute

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: