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

Phase 1

Active, not recruiting

• Conditions: Acne Vulgaris
• Interventions: Drug: Adapalene 0,1% cream; Drug: Combination Cream

• Registration Number: NCT05497323
• Lead Sponsor: Dr.dr.Irma Bernadette, SpKK (K)

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.

Study Timeline

• Study Start: 2022-08-01
• Study First Submitted: 2022-08-09
• Study First Submitted QC: 2022-08-09
• Study First Posted: 2022-08-11
• Primary Completion: 2022-11-15
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-05
• Last Update Posted: 2023-04-06
• Study Completion: 2023-05-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 284

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adapalene 0,1% cream	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.
Combination Cream Group	Combination Cream	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.

Primary Outcome Measures

Name	Time	Method
Change of Level Of Seborrhea	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)
Change of acne severity	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.
Change of quality of life	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.
Facial Analysis Examination With Janus Facial Analysis System	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.
Change of erythema	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.

Trial Locations

Locations (5)

Rumah Sakit Umum Daerah Dr. Moewardi; 🇮🇩 Surakarta, Jawa Tengah, Indonesia

Rumah Sakit Umum Pusat Cipto Mangunkusumo; 🇮🇩 Jakarta, DKI Jakarta, Indonesia

Rumah Sakit Pusat Angkatan Darat Gatot Soebroto; 🇮🇩 Jakarta, DKI Jakarta, Indonesia

Rumah Sakit Umum Daerah Saiful Anwar; 🇮🇩 Malang, Jawa Timur, Indonesia

Rumah Sakit Umum Pusat Dr. M. Djamil; 🇮🇩 Padang, Sumatera Barat, Indonesia