Effectivity and Safety of Metronidazole 1% Cream in Rosacea Therapy

Rosacea Clinical Trial

Official title:

Effectivity and Safety of Metronidazole 1% Cream in Rosacea Therapy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05861310
• Other study ID #: EffectivityofMetro1%Cre
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: May 2023
• Est. completion date: December 2023

Study information

• Verified date: May 2023
• Source: Indonesia University
• Contact: Irma Bernadette Sitohang, MD
• Phone: +62818130761
• Email: irma_bernadette[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: December 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Rosacea

Intervention

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.
• 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.

Locations

Country	Name	City	State
Indonesia	Universitas Indonesia of Hospital	Depok	Jawa Barat
Indonesia	Rumah Sakit Umum Pusat Cipto Mangunkusumo	Jakarta	DKI Jakarta

Sponsors (2)

Lead Sponsor	Collaborator
Dr.dr.Irma Bernadette, SpKK (K)	Science and Technology Park, Center of Innovation Technologies for Human Health

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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