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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: Combination Cream
* Drug: Adapalene 0,1% cream


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combination Cream Group<br>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<br>* 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.<br>* Other names: La Roche Posay, Effaclar Duo (+), dermocosmetic;|
| Other: Adapalene 0,1% cream<br>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<br>* 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.<br>* Other names: Evalen®, topical acne agents;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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combination cream, aqua posae, adjuvant therapy