Effectivity and Safety of Metronidazole 1% Cream in Rosacea Therapy

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Primary Purpose

Status

Not yet recruiting

Phase

Phase 1

Locations

Indonesia

Study Type

Interventional

Intervention

Metronidazole 1% Cream,Top

Placebo

About this trial

This is an interventional treatment trial for Rosacea focused on measuring Rosacea, Erythema

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Rumah Sakit Umum Pusat Cipto Mangunkusumo
Universitas Indonesia of Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Metronidazole 1% Group

Placebo Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05861310

First Posted

April 6, 2023

Last Updated

May 14, 2023

Sponsor

Dr.dr.Irma Bernadette, SpKK (K)

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT05861310

Brief Title

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

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

May 2023 (Anticipated)

Primary Completion Date

July 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Dr.dr.Irma Bernadette, SpKK (K)

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rosacea

Keywords

Rosacea, Erythema

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

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.

Masking

Outcomes Assessor

Masking Description

The investigator who evaluated the outcomes assessor will be blinded to the treatment allocation until the end of data collection.

Allocation

Randomized

Enrollment

48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Metronidazole 1% Group

Arm Type

Experimental

Arm Description

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.

Arm Title

Placebo Group

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Metronidazole 1% Cream,Top

Other Intervention Name(s)

Metronidazole 1%

Intervention Description

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

Intervention Name(s)

Placebo

Intervention Description

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.

Primary Outcome Measure Information:

Title

The degree of erythema Examination

Description

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.

Time Frame

Day 0

Title

The degree of erythema Examination

Description

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.

Time Frame

Re-evaluation on days 28

Title

The degree of erythema Examination

Description

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.

Time Frame

Re-evaluation on days 56 post-intervention

Title

Dermoscopy Examination

Description

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.

Time Frame

Day 0

Title

Dermoscopy Examination

Description

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.

Time Frame

Re-evaluation on days 28

Title

Dermoscopy Examination

Description

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.

Time Frame

Re-evaluation on days 56 post-intervention

Title

Demodex Examination

Description

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.

Time Frame

Day 0

Title

Demodex Examination

Description

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.

Time Frame

Re-evaluation on days 28

Title

Demodex Examination

Description

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.

Time Frame

Re-evaluation on days 56 post-intervention

Title

Transepidermal water loss Examination

Description

Transepidermal water loss evaluated by the TewameterⓇ. Water evaporation rate in a given area of skin, reported in gram/m²/hour.

Time Frame

Day 0, Re-evaluation on days 28 and days 56 post-intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Irma Bernadette Sitohang, MD

Phone

+62818130761

Email

irma_bernadette@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Irma Bernadette Sitohang, MD

Organizational Affiliation

Faculty of Medicine, University of Indonesia

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Rinadewi Astriningrum, MD

Organizational Affiliation

Faculty of Medicine, University of Indonesia

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Ika Anggraini, MD

Organizational Affiliation

Indonesia University of Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Wresti Indriatmi, MD

Organizational Affiliation

Faculty of Medicine, University of Indonesia

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Sutriyo M.Si, Dr

Organizational Affiliation

Faculty of Medicine, University of Indonesia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rumah Sakit Umum Pusat Cipto Mangunkusumo

City

Jakarta

State/Province

DKI Jakarta

ZIP/Postal Code

10430

Country

Indonesia

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Irma Bernadette Sitohang, MD

Phone

+62818130761

Email

irma_bernadette@yahoo.com

First Name & Middle Initial & Last Name & Degree

Irma Bernadette Sitohang, MD

First Name & Middle Initial & Last Name & Degree

Rinadewi Astriningrum, MD

First Name & Middle Initial & Last Name & Degree

Ika Anggraini, MD

First Name & Middle Initial & Last Name & Degree

Wresti Indriatmi,, MD

Facility Name

Universitas Indonesia of Hospital

City

Depok

State/Province

Jawa Barat

ZIP/Postal Code

16424

Country

Indonesia

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Irma Bernadette Sitohang, MD

Phone

+62818130761

Email

irma_bernadette@yahoo.com

First Name & Middle Initial & Last Name & Degree

Irma Bernadette Sitohang, MD

First Name & Middle Initial & Last Name & Degree

Ika Anggraini, MD

Rosacea

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial