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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
284
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 were given to subjects to be applied every night in group 1 and group 3, and intermittently every two nights in group 2.
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
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.
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: re-evaluation on day 28 and day 56 of therapy
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.