Effectivity and Safety of Metronidazole 1% Cream in Rosacea Therapy
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 48
- Locations
- 2
- Primary Endpoint
- Dermoscopy Examination
Study Overview
Brief 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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
The investigator who evaluated the outcomes assessor will be blinded to the treatment allocation until the end of data collection.
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Metronidazole 1% Group
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.
Intervention: Metronidazole 1% Cream,Top (Drug)
Placebo Group
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.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Dermoscopy Examination
Time Frame: Re-evaluation on days 56 post-intervention
Skin surface is evaluated by dermoscopy examination. This examination is to see whether there are open comedones surrounded by a thin ring of hyperpigmentation as a picture of Dermodex.
Transepidermal water loss Examination
Time Frame: Day 0, Re-evaluation on days 28 and days 56 post-intervention
Transepidermal water loss evaluated by the TewameterⓇ. Water evaporation rate in a given area of skin, reported in gram/m²/hour.
Demodex Examination
Time Frame: Re-evaluation on days 56 post-intervention
Examination of the amount of demodex on the skin is evaluated by examining skin scrapings. In the diagnosis of rosacea, the number of demodex found is more than 5 mites/cm2.
The degree of erythema Examination
Time Frame: Re-evaluation on days 56 post-intervention
The degree of erythema are evaluated with the Clinician Erythema Assessment Scale (CEA) score. Based on the score of the Clinician Erythema Assessment Scale (CEA), it has a score of 0 if there is no sign of erythema and a score of 4 if the erythema is moderate-severe. The degree of erythema are evaluated with the Clinician Erythema Assessment Scale (CEA) score. Based on the score of the Clinician Erythema Assessment Scale (CEA), it has a score of 0 if there is no sign of erythema and a score of 4 if the erythema is moderate-severe.
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr.dr.Irma Bernadette, SpKK (K)
Prof. Dr. dr. Irma Bernadette S. Sitohang, SpKK - Head of Cosmetic Dermatology Division, Department of Dermatology and Venereology, Faculty of Medicine, Universitas Indonesia, dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia
Indonesia University