RosaceaPhase 1NCT05861310
Effectivity and Safety of Metronidazole 1% Cream in Rosacea Therapy
A Phase 1 study testing Metronidazole 1% Cream,Top in people with Rosacea, run by Dr.dr.Irma Bernadette, SpKK (K) at 2 sites in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Rosacea
- What is being tested?
- Metronidazole 1% Cream,Top
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 2 sitesIndonesia
- Study dates
- May 2023to Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and Female, aged 18-60 years
- Diagnosed with rosacea
- The patient agreed to participate in the study and signed a inform consent
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
Indonesia2 sites
Universitas Indonesia of Hospital
Depok, West Java, 16424
Irma Bernadette Sitohang, MD, +62818130761, irma_bernadette@yahoo.com
Irma Bernadette Sitohang, MD
Rumah Sakit Umum Pusat Cipto Mangunkusumo
Jakarta, DKI Jakarta, 10430
Irma Bernadette Sitohang, MD, +62818130761, irma_bernadette@yahoo.com
Irma Bernadette Sitohang, MD
About this study
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.
Read the 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
- Being tested
- Metronidazole 1% Cream,Top, Placebo
- Keywords
- Rosacea, Erythema
- Medical subject headings
- Rosacea, Erythema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metronidazole 1% Cream,TopDrug
Also called Metronidazole 1%
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 0, Re-evaluation on days 28 and days 56 post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study startMay 2023 (estimated)
- Primary completionJul 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RosaceaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr.dr.Irma Bernadette, SpKK (K)
- Sponsor type
- University, hospital or other
- Collaborators
- Science and Technology Park, Center of Innovation Technologies for Human Health
- Responsible party
- Sponsor-investigator, Dr.dr.Irma Bernadette, SpKK (K), Universitas Indonesia
- Investigators
- Irma Bernadette Sitohang, MD, Principal investigator, Faculty of Medicine, University of IndonesiaRinadewi Astriningrum, MD, Principal investigator, Faculty of Medicine, University of IndonesiaIka Anggraini, MD, Principal investigator, Indonesia University of HospitalWresti Indriatmi, MD, Principal investigator, Faculty of Medicine, University of IndonesiaSutriyo M.Si, Dr, Principal investigator, Faculty of Medicine, University of Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05861310
- Sponsor's protocol ID
- EffectivityofMetro1%Cre
- Status last verified
- May 2023
- First submitted
- 6 Apr 2023
- Last updated
- 16 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectivity and Safety of Metronidazole 1% Cream in Rosacea Therapy
- ClinicalTrials.gov ID
- NCT05861310
- Acronym / sponsor ID
- EffectivityofMetro1%Cre
- Conditions
- Rosacea
- Keywords
- Rosacea, Erythema
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Dr.dr.Irma Bernadette, SpKK (K)University, hospital or other
- Collaborators
- Science and Technology Park, Center of Innovation Technologies for Human Health
- Study start
- May 2023 (estimated)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 16 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Metronidazole 1% Group | Experimental | Drug: Metronidazole 1% Cream,TopMetronidazole 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 Group | Experimental | Drug: PlaceboPlacebo 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male and Female, aged 18-60 years
- Diagnosed with rosacea
- The patient agreed to participate in the study and signed a inform consent
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metronidazole 1% Cream,TopAlso: Metronidazole 1%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. | Drug | Metronidazole 1% Group |
| PlaceboCream 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. | Drug | Placebo Group |
Primary outcome
The degree of erythema Examination
Time frame: Day 0
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
Time frame: Re-evaluation on days 28
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
Time frame: Re-evaluation on days 56 post-intervention
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
Time frame: Day 0
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
Time frame: Re-evaluation on days 28
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
Time frame: Re-evaluation on days 56 post-intervention
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
Time frame: Day 0
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
Time frame: Re-evaluation on days 28
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
Time frame: Re-evaluation on days 56 post-intervention
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
Time frame: Day 0, Re-evaluation on days 28 and days 56 post-intervention
Transepidermal water loss evaluated by the TewameterⓇ. Water evaporation rate in a given area of skin, reported in gram/m²/hour.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irma Bernadette Sitohang, MD principal investigator
Faculty of Medicine, University of Indonesia
Rinadewi Astriningrum, MD principal investigator
Faculty of Medicine, University of Indonesia
Ika Anggraini, MD principal investigator
Indonesia University of Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Metronidazole 1% Cream,Top in people with Rosacea, run by Dr.dr.Irma Bernadette, SpKK (K) at 2 sites in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Irma Bernadette Sitohang, MD (+62818130761, irma_bernadette@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The degree of erythema Examination (time frame: Day 0). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2023.