Effectivity and Safety of Metronidazole 1% Cream in Rosacea Therapy

Dr.dr.Irma Bernadette, SpKK (K)

Status and phase: Not yet enrolling; Phase 1

Conditions: Rosacea

Treatments: Drug: Placebo; Drug: Metronidazole 1% Cream,Top

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05861310

EffectivityofMetro1%Cre

Details and patient eligibility

About

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.

Full description

This study is an experimental study with a double-blind randomized controlled trial (RCT) design for researchers and subjects in male and female patients aged 18-60 years who meet the inclusion criteria. This study used 1% metronidazole cream and placebo cream as a comparison. The creams will then be coded as cream A and cream B. This research will be conducted in two places, namely the Dermatology and Venereology Polyclinic, Division of Cosmetic Dermatology, Cipto Mangunkusumo Hospital (RSCM) and the Dermatology and Venereology Polyclinic, University of Indonesia Hospital (RSUI). The control group will use placebo cream (without the drug substance) and the comparison group will use metronidazole 1% cream. All participants will be evaluated twice on days 28 and days 56. Evaluation of response to therapy that will be assessed includes 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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male and Female, aged 18-60 years
• Diagnosed with rosacea
• The patient agreed to participate in the study and signed a inform consent

Exclusion criteria

• Taking corticosteroid therapy (oral or topical)
• Patients with a history of using topical therapy on the face within one month before the study
• Taking metronidazole, clarithromycin, or azithromycin within one month before the study
• Patients who are frequently exposed to ultraviolet (UV) light
• Pregnant or breastfeeding
• Patient and/or family do not agree to participate

Drop Out Criteria:

• Pass away during the clinical trial
• Research subjects were not present when scheduling the action or did not comply with the research protocol.
• Research subjects were not present when scheduling the action or did not comply with the research protocol.
• Suffer from coronavirus disease 2019 (COVID-19) at any time during the trial
• Experience major adverse event(s) caused by topical products or treatments given in the clinical trial (e.g. allergic drug eruption or contact dermatitis). The participants will receive appropriate management if such event occurs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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48 participants in 2 patient groups

Metronidazole 1% Group

Experimental group

Description:

Metronidazole 1% cream is applied to the entire face twice a day. Giving cream in the morning and at night. Evaluation will be carried out on days 28 and 56.

Treatment:

Drug: Metronidazole 1% Cream,Top

Placebo Group

Experimental group

Description:

Placebo cream (without the drug substance) is applied to the entire face twice a day. Giving cream in the morning and at night. Evaluation will be carried out on days 28 and 56.

Treatment:

Drug: Placebo