NCT06775314

Brief Summary

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. 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. 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?

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
102

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2025

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 15, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

January 16, 2025

Status Verified

January 1, 2025

Enrollment Period

2 months

First QC Date

January 13, 2025

Last Update Submit

January 14, 2025

Conditions

Acne Vulgaris

Keywords

acne vulgarisTriethyl citratePyruvic acidEthyl linoleateGT peptide-10Salicylic acid 0,5%Zinc lactateHyaluronic acidHonokiol

Outcome Measures

Primary Outcomes (7)

  • 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

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

  • Change of acne severity

    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

    The total lesion will be examined by dermatologist

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

  • acne sequelae

    The acne sequelae will be examined by dermatologist

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

  • Quality of life

    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

    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

    The facial analysis will be done by using janus facial analysis system

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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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% creamDrug: placebo cleanserDrug: placebo cream combinationDrug: placebo spot cream

Treatment

ACTIVE COMPARATOR

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: CleanserDrug: Combination creamDrug: spot creamDrug: Adapalene 0,1% cream

Interventions

CleanserDRUG

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

Treatment
Combination creamDRUG

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

Treatment
spot creamDRUG

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

Treatment
Adapalene 0,1% creamDRUG

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

PlaceboTreatment
placebo cleanserDRUG

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

Placebo
placebo cream combinationDRUG

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

Placebo
placebo spot creamDRUG

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

Placebo

Eligibility Criteria

Age15 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rumah Sakit Pusat Angkatan Darat Gatot Soebroto

Jakarta, Jakarta Pusat, 10410, Indonesia

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Lidocaine, Prilocaine Drug Combination

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

LidocaineAcetanilidesAnilidesAmidesOrganic ChemicalsPrilocaineAniline CompoundsAminesDrug CombinationsPharmaceutical Preparations

Central Study Contacts

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

CONTACT

+62818130761irma_bernadette@yahoo.com

dr. Lilik Norawati, Sp.DVE

CONTACT

+628121107149liliknora21@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr. dr. Irma Bernadette, Sp.DVE, Subsp. D.K.E

Study Record Dates

First Submitted

January 13, 2025

First Posted

January 15, 2025

Study Start

March 1, 2025

Primary Completion

May 1, 2025

Study Completion

June 30, 2025

Last Updated

January 16, 2025

Record last verified: 2025-01

Locations

ID(1)