Effectivity and Safety of Combination Cream of Salicylic Acid,Aqua Posae Filiformis,Niacinamide,Lipohydroxy Acid,Procerad,and Zinc PCA
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Drug: 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.
|
| Other: 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. |
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.
|
Outcome Measures
Primary Outcome Measures
- Change of acne severity [re-evaluation on day 28 and day 56 of therapy]
Based on Global Acne Severity Scale (GEA Score). On a scale of 0-5, 0 indicates almost no lesions, while 5 indicates severe acne.
- 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 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 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.
- Change of quality of life [re-evaluation on day 28 and day 56 of therapy]
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).
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Female aged 15 - 50 years
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Mild and moderate acne vulgaris according to IAEM and GEA.
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Patients are willing to participate in the study until it is finished.
Exclusion Criteria:
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History of allergy to dermatocosmetic products.
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Undergoing other acne therapy, medication, or invasive action in the last month.
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Pregnant or breastfeeding patients
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rumah Sakit Pusat Angkatan Darat Gatot Soebroto | Jakarta | DKI Jakarta | Indonesia | 10410 |
| 2 | Rumah Sakit Umum Pusat Cipto Mangunkusumo | Jakarta | DKI Jakarta | Indonesia | 10430 |
| 3 | Rumah Sakit Umum Daerah Dr. Moewardi | Surakarta | Jawa Tengah | Indonesia | |
| 4 | Rumah Sakit Umum Daerah Saiful Anwar | Malang | Jawa Timur | Indonesia | |
| 5 | Rumah Sakit Umum Pusat Dr. M. Djamil | Padang | Sumatera Barat | Indonesia |
Sponsors and Collaborators
- Dr.dr.Irma Bernadette, SpKK (K)
Investigators
- Principal Investigator: Irma BS Sitohang, MD, Fakultas Kedokteran Universitas Indonesia
- Study Director: Lilik Norawati, MD, Departemen Ilmu Kesehatan Kulit dan Kelamin Rumah Sakit Pusat Angkatan Darat Gatot Soebroto,
- Study Director: Satya WY Yenny, MD, Departemen Ilmu Kesehatan Kulit dan Kelamin Rumah Sakit Umum Pusat Dr. M. Djamil, Padang
- Study Director: Arie Kusumawardani, Departemen Ilmu Kesehatan Kulit dan Kelamin Rumah Sakit Umum Daerah Dr. Moewardi, Surakarta
- Study Director: Sinta Murlistyarini, Departemen Ilmu Kesehatan Kulit dan Kelamin Rumah Sakit Umum Daerah Saiful Anwar, Malang
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EffectivityCombiAquaPosae