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

NCT ID: NCT05497323

Last Updated: 2023-04-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 284 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2023-05-01

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.

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.

Conditions

Acne Vulgaris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Combination Cream

Intervention Type: DRUG

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.

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.

Group Type: OTHER

Adapalene 0,1% cream

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

La Roche Posay, Effaclar Duo (+), dermocosmetic; Evalen®, topical acne agents

Eligibility Criteria

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Dr.dr.Irma Bernadette, SpKK (K)

OTHER

Sponsor Role: lead

Responsible Party

Dr.dr.Irma Bernadette, SpKK (K)

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

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Irma BS Sitohang, MD

Role: PRINCIPAL_INVESTIGATOR

Fakultas Kedokteran Universitas Indonesia

Lilik Norawati, MD

Role: STUDY_DIRECTOR

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

Satya WY Yenny, MD

Role: STUDY_DIRECTOR

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

Arie Kusumawardani

Role: STUDY_DIRECTOR

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

Sinta Murlistyarini

Role: STUDY_DIRECTOR

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

Locations

Rumah Sakit Umum Daerah Dr. Moewardi

Surakarta, Central Java, Indonesia

Rumah Sakit Pusat Angkatan Darat Gatot Soebroto

Jakarta, DKI Jakarta, Indonesia

Rumah Sakit Umum Pusat Cipto Mangunkusumo

Jakarta, DKI Jakarta, Indonesia

Rumah Sakit Umum Daerah Saiful Anwar

Malang, East Java, Indonesia

Rumah Sakit Umum Pusat Dr. M. Djamil

Padang, West Sumatra, Indonesia

Countries

Indonesia

Other Identifiers

EffectivityCombiAquaPosae

Identifier Type: -

Identifier Source: org_study_id