Clinical trial NCT05861310: Effectivity and Safety of Metronidazole 1% Cream in Rosacea Therapy
Official title: Effectivity and Safety of Metronidazole 1% Cream in Rosacea Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Rosacea
Keywords: Rosacea
Erythema
Lead sponsor: Indonesia University
Sponsor class: OTHER
Collaborators: name: Science and Technology Park, Center of Innovation Technologies for Human Health
First posted: 2023-05-16
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Each research subject will receive a different cream and will be given randomly according to a computer program by a statistician. The control group will receive placebo cream (without the drug substance) and the comparison group will receive metronidazole 1% cream. The cream is used for 2 months and will be evaluated every 28 days.
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: The degree of erythema Examination
timeFrame: Day 0
measure: The degree of erythema Examination
timeFrame: Re-evaluation on days 28
measure: The degree of erythema Examination
timeFrame: Re-evaluation on days 56 post-intervention
measure: Dermoscopy Examination
timeFrame: Day 0
measure: Dermoscopy Examination
timeFrame: Re-evaluation on days 28
measure: Dermoscopy Examination
timeFrame: Re-evaluation on days 56 post-intervention
measure: Demodex Examination
timeFrame: Day 0
measure: Demodex Examination
timeFrame: Re-evaluation on days 28
measure: Demodex Examination
timeFrame: Re-evaluation on days 56 post-intervention
measure: Transepidermal water loss Examination
timeFrame: Day 0, Re-evaluation on days 28 and days 56 post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Rumah Sakit Umum Pusat Cipto Mangunkusumo
state: DKI Jakarta
city: Depok
country: Indonesia
facility: Universitas Indonesia of Hospital
state: Jawa Barat
Study officials:
affiliation: Faculty of Medicine, University of Indonesia
name: Irma Bernadette Sitohang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Medicine, University of Indonesia
name: Rinadewi Astriningrum, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Indonesia University of Hospital
name: Ika Anggraini, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Medicine, University of Indonesia
name: Wresti Indriatmi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Medicine, University of Indonesia
name: Sutriyo M.Si, Dr
role: PRINCIPAL_INVESTIGATOR
References: