Effectivity and Safety of Metronidazole 1% Cream in Rosacea Therapy

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Dr.dr.Irma Bernadette, SpKK (K)
• Collaborator: Science and Technology Park, Center of Innovation Technologies for Human Health
• Treatments: Metronidazole

Criteria

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