Effectivity and Safety of Metronidazole 1% Cream in Rosacea Therapy

NCT05861310 | Unknown Phase 1

• 1 other identifier: EffectivityofMetro1%Cre
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

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.

Conditions

Rosacea

Keywords

Rosacea; Erythema

Outcome Measures

Primary Outcomes (10)

• 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

Study Arms (2)

Metronidazole 1% Group

EXPERIMENTAL

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

Placebo Group

EXPERIMENTAL

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

Interventions

Metronidazole 1% Cream,Top 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.

Also known as: Metronidazole 1%

Metronidazole 1% Group

Placebo 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.

Placebo Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male and Female, aged 18-60 years
• Diagnosed with rosacea
• The patient agreed to participate in the study and signed a inform consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr.dr.Irma Bernadette, SpKK (K): lead
• Science and Technology Park, Center of Innovation Technologies for Human Health: collaborator

Study Sites (2)

Rumah Sakit Umum Pusat Cipto Mangunkusumo

Jakarta, DKI Jakarta, 10430, Indonesia

Location

Universitas Indonesia of Hospital

Depok, West Java, 16424, Indonesia

Location

MeSH Terms

Conditions

Rosacea; Erythema

Interventions

Metronidazole

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Irma Bernadette Sitohang, MD

CONTACT

+62818130761; irma_bernadette@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The investigator who evaluated the outcomes assessor will be blinded to the treatment allocation until the end of data collection.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: 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

Model Details: 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.

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: May 16, 2023
• Study Start: May 1, 2023
• Primary Completion: July 1, 2023
• Study Completion: December 1, 2023
• Last Updated: May 16, 2023

Record last verified: 2023-05

Locations

ID (2)