Effectivity and Safety of Metronidazole 1% Cream in Rosacea Therapy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Rosacea
• Intervention / Treatment: Drug: Metronidazole 1% Cream,Top; Drug: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Irma Bernadette Sitohang, MD; Phone Number: +62818130761; Email: irma_bernadette@yahoo.com

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta, DKI Jakarta, Indonesia, 10430
      • Rumah Sakit Umum Pusat Cipto Mangunkusumo
      • Contact: Irma Bernadette Sitohang, MD; Phone Number: +62818130761; Email: irma_bernadette@yahoo.com
      • Principal Investigator: Irma Bernadette Sitohang, MD
      • Sub-Investigator: Rinadewi Astriningrum, MD
      • Sub-Investigator: Ika Anggraini, MD
      • Sub-Investigator: Wresti Indriatmi,, MD
  • Jawa Barat
    • Depok, Jawa Barat, Indonesia, 16424
      • Universitas Indonesia of Hospital
      • Contact: Irma Bernadette Sitohang, MD; Phone Number: +62818130761; Email: irma_bernadette@yahoo.com
      • Principal Investigator: Irma Bernadette Sitohang, MD
      • Sub-Investigator: Ika Anggraini, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; Other Names: Metronidazole 1%
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The degree of erythema Examination	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.	Day 0
The degree of erythema Examination	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.	Re-evaluation on days 28
The degree of erythema Examination	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.	Re-evaluation on days 56 post-intervention
Dermoscopy Examination	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.	Day 0
Dermoscopy Examination	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.	Re-evaluation on days 28
Dermoscopy Examination	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.	Re-evaluation on days 56 post-intervention
Demodex Examination	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.	Day 0
Demodex Examination	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.	Re-evaluation on days 28
Demodex Examination	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.	Re-evaluation on days 56 post-intervention
Transepidermal water loss Examination	Transepidermal water loss evaluated by the TewameterⓇ. Water evaporation rate in a given area of skin, reported in gram/m²/hour.	Day 0, Re-evaluation on days 28 and days 56 post-intervention

Collaborators and Investigators

• Sponsor: Dr.dr.Irma Bernadette, SpKK (K)
• Collaborators: Science and Technology Park, Center of Innovation Technologies for Human Health
• Investigators: Principal Investigator: Irma Bernadette Sitohang, MD, Faculty of medicine, University of Indonesia; Principal Investigator: Rinadewi Astriningrum, MD, Faculty of medicine, University of Indonesia; Principal Investigator: Ika Anggraini, MD, Indonesia University of Hospital; Principal Investigator: Wresti Indriatmi, MD, Faculty of medicine, University of Indonesia; Principal Investigator: Sutriyo M.Si, Dr, Faculty of medicine, University of Indonesia

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2023
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: April 6, 2023
• First Submitted That Met QC Criteria: May 14, 2023
• First Posted (Actual): May 16, 2023

Study Record Updates

• Last Update Posted (Actual): May 16, 2023
• Last Update Submitted That Met QC Criteria: May 14, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Rosacea; Erythema
• Additional Relevant MeSH Terms: Skin Diseases; Rosacea; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Metronidazole
• Other Study ID Numbers: EffectivityofMetro1%Cre

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No