Effectivity and Safety of Combination Cream of Salicylic Acid, Aqua Posae Filiformis, Niacinamide, Lipohydroxy Acid, Procerad and Zinc PCA

April 5, 2023 updated by: Dr.dr.Irma Bernadette, SpKK (K)

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 Mild to Moderate

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is an experimental study with a randomized controlled trial (RCT) design on mild to moderate acne vulgaris patients who met the inclusion criteria. This study will be conducted in five Dermatology and Venereology Education Centers in Indonesia located in Jakarta (Rumah Sakit Umum Pusat Nasional dr. Cipto Mangunkusumo), Jakarta (Rumah Sakit Pusat Angkatan Darat Gatot Soebroto), Padang (Rumah Sakit Umum Pusat Dr. M. Djamil), Surakarta (Rumah Sakit Umum Daerah Dr. Moewardi), and Malang (Rumah Sakit Umum Daerah Dr. Saiful Anwar). Group 1 as control group, will receive Adapalene 0.1% cream only every night. Group 2 will receive Adapalene 0.1% cream only 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. All participants will be evaluated in day 28 and 56. Therapy evaluation will be assessed based on the Global Acne Severity Scale (GEA Score), Indonesia Acne Expert Meeting (IAEM Score), Level of Seborrhoea, Clinician Erythema Assessment Scale (CEA), facial skin analysis with Janus Skin Facial Analysis, and evaluation of the quality of life using Cardiff Acne Disability Index and Acne-Quality of Life (Acne-QoL) specifically for participants aged older than 18 years old.

Study Type

Interventional

Enrollment (Actual)

284

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta, DKI Jakarta, Indonesia, 10410
        • Rumah Sakit Pusat Angkatan Darat Gatot Soebroto
      • Jakarta, DKI Jakarta, Indonesia, 10430
        • Rumah Sakit Umum Pusat Cipto Mangunkusumo
    • Jawa Tengah
      • Surakarta, Jawa Tengah, Indonesia
        • Rumah Sakit Umum Daerah Dr. Moewardi
    • Jawa Timur
      • Malang, Jawa Timur, Indonesia
        • Rumah Sakit Umum Daerah Saiful Anwar
    • Sumatera Barat
      • Padang, Sumatera Barat, Indonesia
        • Rumah Sakit Umum Pusat Dr. M. Djamil

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Combination Cream Group
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
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.
Other Names:
  • La Roche Posay, Effaclar Duo (+), dermocosmetic
Other: Adapalene 0,1% cream
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
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.
Other Names:
  • Evalen®, topical acne agents

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of acne severity
Time Frame: re-evaluation on day 28 and day 56 of therapy
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
Time Frame: re-evaluation on day 28 and day 56 of therapy
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
Time Frame: re-evaluation on day 28 and day 56 of therapy
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
Time Frame: re-evaluation on day 28 and day 56 of therapy
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
Time Frame: re-evaluation on day 28 and day 56 of therapy
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
Time Frame: re-evaluation on day 28 and day 56 of therapy
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
Time Frame: re-evaluation on day 28 and day 56 of therapy
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr.dr.Irma Bernadette, SpKK (K)

Investigators

  • Study Director: 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Actual)

November 15, 2022

Study Completion (Anticipated)

May 1, 2023

Study Registration Dates

First Submitted

August 9, 2022

First Submitted That Met QC Criteria

August 9, 2022

First Posted (Actual)

August 11, 2022

Study Record Updates

Last Update Posted (Actual)

April 6, 2023

Last Update Submitted That Met QC Criteria

April 5, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EffectivityCombiAquaPosae

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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