NCT05497323

Brief Summary

This clinical study will compare the effectivity and safety of combination cream of Salicylic Acid, Aqua Posae Filiformis, Niacinamide, Lipohydroxy Acid, Procerad, and Zinc PCA as adjuvant therapy for acne vulgaris patients. These combination cream will be tested by mild to moderate acne vulgaris patients. Participants will be female patients aged 15-50 years old and divided into three groups. The control group (Group 1) will use Adapalene 0.1% cream only every night. Group 2 will use Adapalene 0.1% cream intermittently every two nights and the combination cream every morning. Group 3 will use Adapalene 0.1% cream every night and the combination cream every morning.

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
284

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

5 active sites

Status
unknown

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

Study Start

First participant enrolled

August 1, 2022

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 9, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 11, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

April 6, 2023

Status Verified

April 1, 2023

Enrollment Period

4 months

First QC Date

August 9, 2022

Last Update Submit

April 5, 2023

Conditions

Acne Vulgaris

Keywords

combination creamaqua posaeadjuvant therapy

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 almost no lesions, while 5 indicates severe acne.

    re-evaluation on day 28 and day 56 of therapy

  • Change of acne severity

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

    re-evaluation on day 28 and day 56 of therapy

  • Change of Level Of Seborrhea

    The level of seborrhea is assessed subjectively by participants on a scale of 0 (minimum level) - 10 (maximum level)

    re-evaluation on day 28 and day 56 of therapy

  • Change of erythema

    Based on Clinician Erythema Assessment Scale (CEA) to assess the degree and extent of erythema. The scale ranges from 0-5; 0 indicates no erythema, while 4 indicates severe erythema.

    re-evaluation on day 28 and day 56 of therapy

  • Change of quality of life

    Assessed using Cardiff Acne Disability Index. Cardiff Acne Disability Index questionnaire is an instrument to measure the quality of life of acne vulgaris patients. This instrument has 5 self-answered questions by the patient (for subjects aged≥ 18 years).

    re-evaluation on day 28 and day 56 of therapy

  • Change of quality of life

    Assessed using Acne-Quality of Life. Acne-QoL is an instrument consisting of 19 questions divided into 4 categories: self-perception, social relationships, emotional effects, and acne symptoms. The total score of Acne-QoL is 0-114. The higher total score for each category obtained will interpret that the quality of life of acne vulgaris patients is getting better.

    re-evaluation on day 28 and day 56 of therapy

  • Facial Analysis Examination With Janus Facial Analysis System

    Assessed using the Janus Facial Analysis System®. Janus Facial Analysis System will issue data related to the patient's facial condition.

    re-evaluation on day 28 and day 56 of therapy

Study Arms (2)

Combination Cream Group

EXPERIMENTAL

Group 2 will use Adapalene 0.1% cream intermittently every two nights and the combination cream every morning. Group 3 will use Adapalene 0.1% cream every night and the combination cream every morning. Subjects were evaluated on day 28 and day 56.

Drug: Combination Cream

Adapalene 0,1% cream

OTHER

The control group (Group 1) will use Adapalene 0.1% cream only every night. Subjects were evaluated on day 28 and day 56.

Drug: Adapalene 0,1% cream

Interventions

Combination CreamDRUG

The combination cream consists of Salicylic Acid, Aqua Posae Filiformis, Niacinamide, Lipohydroxy Acid, Procerad and Zinc PCA, were applied every morning by group 2 and group 3.

Also known as: La Roche Posay, Effaclar Duo (+), dermocosmetic
Combination Cream Group
Adapalene 0,1% creamDRUG

Adapalene 0,1 % cream were given to subjects to be applied every night in group 1 and group 3, and intermittently every two nights in group 2.

Also known as: Evalen®, topical acne agents
Adapalene 0,1% cream

Eligibility Criteria

Age15 Years - 50 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Female aged 15 - 50 years
  • Mild and moderate acne vulgaris according to IAEM and GEA.
  • Patients are willing to participate in the study until it is finished.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Rumah Sakit Umum Daerah Dr. Moewardi

Surakarta, Central Java, Indonesia

Location

Rumah Sakit Pusat Angkatan Darat Gatot Soebroto

Jakarta, DKI Jakarta, 10410, Indonesia

Location

Rumah Sakit Umum Pusat Cipto Mangunkusumo

Jakarta, DKI Jakarta, 10430, Indonesia

Location

Rumah Sakit Umum Daerah Saiful Anwar

Malang, East Java, Indonesia

Location

Rumah Sakit Umum Pusat Dr. M. Djamil

Padang, West Sumatra, Indonesia

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Lidocaine, Prilocaine Drug CombinationBenzoyl Peroxide

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

LidocaineAcetanilidesAnilidesAmidesOrganic ChemicalsPrilocaineAniline CompoundsAminesDrug CombinationsPharmaceutical PreparationsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Irma BS Sitohang, MD

    Fakultas Kedokteran Universitas Indonesia

    PRINCIPAL INVESTIGATOR

  • Lilik Norawati, MD

    Departemen Ilmu Kesehatan Kulit dan Kelamin Rumah Sakit Pusat Angkatan Darat Gatot Soebroto,

    STUDY DIRECTOR

  • Satya WY Yenny, MD

    Departemen Ilmu Kesehatan Kulit dan Kelamin Rumah Sakit Umum Pusat Dr. M. Djamil, Padang

    STUDY DIRECTOR

  • Arie Kusumawardani

    Departemen Ilmu Kesehatan Kulit dan Kelamin Rumah Sakit Umum Daerah Dr. Moewardi, Surakarta

    STUDY DIRECTOR

  • Sinta Murlistyarini

    Departemen Ilmu Kesehatan Kulit dan Kelamin Rumah Sakit Umum Daerah Saiful Anwar, Malang

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr. dr. Irma Bernadette S. Sitohang, SpKK(K) - Head of Cosmetic Dermatology Division of Dermatology and Venereology Department of Faculty of Medicine Universitas Indonesia / Cipto Mangunkusumo Hospital

Study Record Dates

First Submitted

August 9, 2022

First Posted

August 11, 2022

Study Start

August 1, 2022

Primary Completion

November 15, 2022

Study Completion

May 1, 2023

Last Updated

April 6, 2023

Record last verified: 2023-04

Locations

ID(5)