Effectivity and Safety of Metronidazole 1% Cream in Rosacea Therapy

Summary

Rosacea is a chronic inflammatory disease of the central facial region, which can also occur in the neck and chest regions. Microbes that play a role in rosacea are Demodex folliculorum and Helicobactor pylori. On the skin with rosacea have decreased skin barrier function. This clinical study will compare the effectiveness and safety of metronidazole 1% cream as the main therapy in rosacea patients. Participants who will become research subjects are women and men aged 18-60 years who meet the inclusion criteria. Research subjects were divided into 2 groups. The control group will use placebo cream (without the drug substance) and the comparison group will use metronidazole 1% cream.

Conditions

• Rosacea

Interventions

DRUG

Metronidazole 1% Cream,Top

Cream that has an active ingredient in the form of metronidazole with a content of 1%. At the beginning of the study visit, anamnesis and examination of the skin status were carried out. Skin status includes examination of the degree of erythema with a Clinician Erythema Assessment Scale (CEA) score, examination of skin scrapings for demodex examination, dermoscopy examination, and TEWL (Transepidermal Water Loss) examination. Then the participants were given metronidazole 1% cream which was to be used twice a day in the morning and at night. Evaluation of the therapeutic response will be carried out on days 28 and days 56.

DRUG

Placebo

Cream that has not medicine. At the beginning of the study visit, anamnesis and examination of the skin status were carried out. Skin status includes examination of the degree of erythema with a Clinician Erythema Assessment Scale (CEA) score, examination of skin scrapings for demodex examination, dermoscopy examination, and TEWL (Transepidermal Water Loss) examination. Then the research subjects were given Placebo cream (without the drug substance) which was to be used twice a day in the morning and at night. Evaluation of the therapeutic response will be carried out on days 28 and days 56.

Sponsors & Collaborators

• Science and Technology Park, Center of Innovation Technologies for Human Health

  collaborator INDUSTRY

• Dr.dr.Irma Bernadette, SpKK (K)

  lead OTHER

Principal Investigators

• Irma Bernadette Sitohang, MD · Faculty of Medicine, University of Indonesia

• Rinadewi Astriningrum, MD · Faculty of Medicine, University of Indonesia

• Ika Anggraini, MD · Indonesia University of Hospital

• Wresti Indriatmi, MD · Faculty of Medicine, University of Indonesia

• Sutriyo M.Si, Dr · Faculty of Medicine, University of Indonesia

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-05-31

Primary Completion

2023-07-31

Completion

2023-12-31

Countries

• Indonesia

Study Locations