Clinical trial NCT05497323: Effectivity and Safety of Combination Cream of Salicylic Acid, Aqua Posae Filiformis, Niacinamide, Lipohydroxy Acid, Procerad and Zinc PCA
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Acne Vulgaris
Keywords: combination cream
aqua posae
adjuvant therapy
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2022-08-11
Enrollment: 284
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change of acne severity
timeFrame: re-evaluation on day 28 and day 56 of therapy
measure: Change of acne severity
timeFrame: re-evaluation on day 28 and day 56 of therapy
measure: Change of Level Of Seborrhea
timeFrame: re-evaluation on day 28 and day 56 of therapy
measure: Change of erythema
timeFrame: re-evaluation on day 28 and day 56 of therapy
measure: Change of quality of life
timeFrame: re-evaluation on day 28 and day 56 of therapy
measure: Change of quality of life
timeFrame: re-evaluation on day 28 and day 56 of therapy
measure: Facial Analysis Examination With Janus Facial Analysis System
timeFrame: re-evaluation on day 28 and day 56 of therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Rumah Sakit Pusat Angkatan Darat Gatot Soebroto
state: DKI Jakarta
city: Jakarta
country: Indonesia
facility: Rumah Sakit Umum Pusat Cipto Mangunkusumo
state: DKI Jakarta
city: Surakarta
country: Indonesia
facility: Rumah Sakit Umum Daerah Dr. Moewardi
state: Jawa Tengah
city: Malang
country: Indonesia
facility: Rumah Sakit Umum Daerah Saiful Anwar
state: Jawa Timur
city: Padang
country: Indonesia
facility: Rumah Sakit Umum Pusat Dr. M. Djamil
state: Sumatera Barat
Study officials:
affiliation: Fakultas Kedokteran Universitas Indonesia
name: Irma BS Sitohang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Departemen Ilmu Kesehatan Kulit dan Kelamin Rumah Sakit Pusat Angkatan Darat Gatot Soebroto,
name: Lilik Norawati, MD
role: STUDY_DIRECTOR
affiliation: Departemen Ilmu Kesehatan Kulit dan Kelamin Rumah Sakit Umum Pusat Dr. M. Djamil, Padang
name: Satya WY Yenny, MD
role: STUDY_DIRECTOR
affiliation: Departemen Ilmu Kesehatan Kulit dan Kelamin Rumah Sakit Umum Daerah Dr. Moewardi, Surakarta
name: Arie Kusumawardani
role: STUDY_DIRECTOR
affiliation: Departemen Ilmu Kesehatan Kulit dan Kelamin Rumah Sakit Umum Daerah Saiful Anwar, Malang
name: Sinta Murlistyarini
role: STUDY_DIRECTOR
References: