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

Dr.dr.Irma Bernadette, SpKK (K)

Status and phase: Active, not recruiting; Phase 1

Conditions: Acne Vulgaris

Treatments: Drug: Combination Cream; Drug: Adapalene 0,1% cream

Study type: Interventional

Funder types: Other

Identifiers

NCT05497323

EffectivityCombiAquaPosae

Details and patient eligibility

About

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.

Full 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.

Enrollment: 284 patients

Sex: Female

Ages: 15 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

284 participants in 2 patient groups

Combination Cream Group

Experimental group

Description:

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.

Treatment:

Drug: Combination Cream

Adapalene 0,1% cream

Other group

Description:

The control group (Group 1) will use Adapalene 0.1% cream only every night. Subjects were evaluated on day 28 and day 56.

Treatment:

Drug: Adapalene 0,1% cream