Effectivity and Safety of Metronidazole 1% Cream in Rosacea Therapy

NCT ID: NCT05861310

Last Updated: 2023-05-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-31
• Study Completion Date: 2023-12-31

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.

Conditions

Rosacea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Metronidazole 1% Cream,Top

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Metronidazole 1%

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Science and Technology Park, Center of Innovation Technologies for Human Health

INDUSTRY

Sponsor Role: collaborator

Dr.dr.Irma Bernadette, SpKK (K)

OTHER

Sponsor Role: lead

Responsible Party

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

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Irma Bernadette Sitohang, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, University of Indonesia

Rinadewi Astriningrum, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, University of Indonesia

Ika Anggraini, MD

Role: PRINCIPAL_INVESTIGATOR

Indonesia University of Hospital

Wresti Indriatmi, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, University of Indonesia

Sutriyo M.Si, Dr

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, University of Indonesia

Locations

Rumah Sakit Umum Pusat Cipto Mangunkusumo

Jakarta, DKI Jakarta, Indonesia

Universitas Indonesia of Hospital

Depok, West Java, Indonesia

Countries

Indonesia

Central Contacts

Irma Bernadette Sitohang, MD

Role: CONTACT

irma_bernadette@yahoo.com

+62818130761

Facility Contacts

Irma Bernadette Sitohang, MD

Role: primary

irma_bernadette@yahoo.com

+62818130761

Irma Bernadette Sitohang, MD

Role: primary

irma_bernadette@yahoo.com

+62818130761

Other Identifiers

EffectivityofMetro1%Cre

Identifier Type: -

Identifier Source: org_study_id