RosaceaNCT05401422
Brimonidine in Rosacea
A study testing treatment in people with Rosacea, run by Cairo University.
Trial summary
Rosacea is a chronic and relapsing inflammatory cutaneous disorder with highly variable prevalence worldwide. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Rosacea
- What is being tested?
- treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 25 May 2022to 15 Sep 2022
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Patient with current erythematotelangiectatic rosacea
Who cannot join
- Pregnant females. 2-Patients on systemic steroids. 3-Patients complaining of other dermatological disorders mainly photosensitive cutaneous disorder.
- 4- Patients receiving any systemic treatment including retinoids for the previous 1 month or any topical treatment for the previous 2 weeks or any laser sessions for the previous 3months for erythematotelangiectatic rosacea at least.
About this study
Official title: Efficacy and Safety of Combining Doxycycline With Pulsed Dye Laser Versus Topical Brimonidine 0.33% in the Treatment of Erythematotelangiectatic Rosacea: a Comparative Clinical and Dermoscopic Study
Rosacea is a chronic and relapsing inflammatory cutaneous disorder with highly variable prevalence worldwide.
Read the detailed description
In our study, we will compare the safety, efficacy, and adverse effects of low-dose oral doxycycline alone versus combined with pulsed dye laser or topical brimonidine in treating erythematotelangiectatic rosacea in an attempt to build a treatment strategy in a disease with complex pathogenesis.
- Conditions
- Rosacea
- Being tested
- treatment
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treatmentOther
types
| Study group | Role | What they receive |
|---|---|---|
| Pulsed dye laser | Active comparator | Laser Receives: Other: treatment |
| Doxycycline | Active comparator | Drug Receives: Other: treatment |
| Brimonidine gel 0.33% | Active comparator | Topical drug Receives: Other: treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical erythema assessment scale
clinical scale
Measured: 3 months
Secondary outcomes (1)
Thickness of capillaries by dermoscope
Assessment
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start25 May 2022 (estimated)
- Primary completion15 Sep 2022 (estimated)
- Study completion15 Sep 2022 (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.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hagar El Sayed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05401422
- Sponsor's protocol ID
- Rosacea
- Status last verified
- Jun 2022
- First submitted
- 20 May 2022
- Last updated
- 2 Jun 2022
- 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 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Combining Doxycycline With Pulsed Dye Laser Versus Topical Brimonidine 0.33% in the Treatment of Erythematotelangiectatic Rosacea: a Comparative Clinical and Dermoscopic Study
- ClinicalTrials.gov ID
- NCT05401422
- Acronym / sponsor ID
- Rosacea
- Conditions
- Rosacea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 May 2022 (estimated)
- Primary completion
- 15 Sep 2022 (estimated)
- Study completion
- 15 Sep 2022 (estimated)
- First posted
- 2 Jun 2022 (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 and relapsing inflammatory cutaneous disorder with highly variable prevalence worldwide.
Detailed description
In our study, we will compare the safety, efficacy, and adverse effects of low-dose oral doxycycline alone versus combined with pulsed dye laser or topical brimonidine in treating erythematotelangiectatic rosacea in an attempt to build a treatment strategy in a disease with complex pathogenesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pulsed dye laser | Active comparator | Other: treatmentLaser |
| Doxycycline | Active comparator | Other: treatmentDrug |
| Brimonidine gel 0.33% | Active comparator | Other: treatmentTopical drug |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patient with current erythematotelangiectatic rosacea
Key exclusion criteria (2 listed)
- Pregnant females. 2-Patients on systemic steroids. 3-Patients complaining of other dermatological disorders mainly photosensitive cutaneous disorder.
- 4- Patients receiving any systemic treatment including retinoids for the previous 1 month or any topical treatment for the previous 2 weeks or any laser sessions for the previous 3months for erythematotelangiectatic rosacea at least.
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 |
|---|---|---|
| treatmenttypes | Other | Brimonidine gel 0.33%, Doxycycline, Pulsed dye laser |
Primary outcome
Clinical erythema assessment scale
Time frame: 3 months
clinical scale
1 secondary outcome
Thickness of capillaries by dermoscope
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing treatment in people with Rosacea, run by Cairo University.
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 1 inclusion and 2 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 2 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical erythema assessment scale (time frame: 3 months). 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 2 Jun 2022.