RosaceaPhase 4NCT05014906
Efficacy of Oral Minocycline (Solodyn) and Oral Minocycline (Solodyn) Plus Azelaic Acid (Finacea) for Acne Rosacea
A Phase 4 study testing Minocycline 45 MG and Azelaic acid in people with Rosacea, run by Dermatology Specialists Research at 1 site in United States.
Trial summary
Rosacea is one of the most commonly occurring dermatoses treated by dermatologist today. Rosacea is an inflammatory condition of the skin presenting as flushing and or blushing along with redness, swelling, telangiectasia, and acne lesions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rosacea
- What is being tested?
- Minocycline 45 MG and Azelaic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Sep 2011
- Phase
- Phase 4
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 18 or older with clinical diagnosis of rosacea
- must have 10-40 facial inflammatory lesions and less than 2 nodules
- women of child bearing potential must be non lactating
- must have negative urine pregnancy test
- must use effective form of birth control
Who cannot join
- The use of systemic antibiotics within 30 days of study start
- the use of topical medications within 14 - 30 days of study start depending on type of topical medication
- Patients with known sensitivity to tetracyclines
- Patients who have had gastric bypass surgery or are considered achlorhydric
- Patients taking drugs known as photosensitizers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of 45mg Oral Minocycline (Solodyn) and 45mg Oral Minocycline (Solodyn) Plus 15% Azelaic Acid (Finacea) in the Treatment of Acne Rosacea
Rosacea is one of the most commonly occurring dermatoses treated by dermatologist today. Rosacea is an inflammatory condition of the skin presenting as flushing and or blushing along with redness, swelling, telangiectasia, and acne lesions. Minocycline has shown beneficial in the treatment of inflammatory acne lesions in patients with rosacea. This study is to evaluate the efficacy and tolerability of minocycline (Solodyn) alone versus minocycline (Solodyn) in combination with azelaic acid 15%(Finacea) in the treatment of rosacea.
Read the detailed description
This is a multicenter, randomized, outpatient, Investigator-blind study of minocycline 45 mg and minocycline 45 mg plus 15% azelaic acid for the treatment of rosacea.
- Conditions
- Rosacea
- Being tested
- Minocycline 45 MG, Azelaic acid
- Keywords
- rosacea
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minocycline 45 MGDrug
Also called Solodyn
45 mg oral minocyclineonce daily vs 45mg oral minocycline once daily in combination with use of 15% azelaic acid
Azelaic acidDrug
Also called finacea
45 mg oral minocyclineonce daily vs 45mg oral minocycline once daily in combination with use of 15% azelaic acid
| Study group | Role | What they receive |
|---|---|---|
| minocycline, azelaic acid | Active comparator | minocycline vs minocycline in comination with 15% azelaic acid for treatment of rosacea Receives: Drug: Minocycline 45 MG; Drug: Azelaic acid |
| azelaic acid | Experimental | 45 mg oral minocycline vs 45 mg oral minocycline plus 15% azelaic acid in the treatment of facial rosacea Receives: Drug: Minocycline 45 MG; Drug: Azelaic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy analysis of the 12-week reduction in total lesion count
The goal of analysis is to assess evidence of overall effect of 45mg minocycline and overall effect of 45 mg minocycline plus 15% azelaic acid in therapy of patients with acne rosacea.
Measured: 12 weeks
Secondary outcomes (2)
Efficacy analysis of the12 week reduction in IGA (Investigators Global Assessment) per treatment group
Summary of the 12-week reduction in IGA for the full sample, by treatment group
Measured: 12 Weeks
Efficacy analysis of the 12-week reduction in CEA (Clinical Erythema Assessment) per treatment group
Summary of the 12 week reduction in CEA for the full sample, by treatment group
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study startMay 2010
- Primary completionSep 2011
- Study completionSep 2011
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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dermatology Specialists Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James M Jackson, MD, Principal investigator, Dermatology Specialists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05014906
- Sponsor's protocol ID
- ROS001
- Status last verified
- Aug 2021
- First submitted
- 22 Nov 2013
- Last updated
- 20 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of 45mg Oral Minocycline (Solodyn) and 45mg Oral Minocycline (Solodyn) Plus 15% Azelaic Acid (Finacea) in the Treatment of Acne Rosacea
- ClinicalTrials.gov ID
- NCT05014906
- Acronym / sponsor ID
- ROS001
- Conditions
- Rosacea
- Keywords
- rosacea
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dermatology Specialists ResearchUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 20 Aug 2021 (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 one of the most commonly occurring dermatoses treated by dermatologist today. Rosacea is an inflammatory condition of the skin presenting as flushing and or blushing along with redness, swelling, telangiectasia, and acne lesions. Minocycline has shown beneficial in the treatment of inflammatory acne lesions in patients with rosacea. This study is to evaluate the efficacy and tolerability of minocycline (Solodyn) alone versus minocycline (Solodyn) in combination with azelaic acid 15%(Finacea) in the treatment of rosacea.
Detailed description
This is a multicenter, randomized, outpatient, Investigator-blind study of minocycline 45 mg and minocycline 45 mg plus 15% azelaic acid for the treatment of rosacea.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| minocycline, azelaic acid | Active comparator | Drug: Minocycline 45 MG, Drug: Azelaic acidminocycline vs minocycline in comination with 15% azelaic acid for treatment of rosacea |
| azelaic acid | Experimental | Drug: Minocycline 45 MG, Drug: Azelaic acid45 mg oral minocycline vs 45 mg oral minocycline plus 15% azelaic acid in the treatment of facial rosacea |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age 18 or older with clinical diagnosis of rosacea
- must have 10-40 facial inflammatory lesions and less than 2 nodules
- women of child bearing potential must be non lactating
- must have negative urine pregnancy test
- must use effective form of birth control
Key exclusion criteria (5 listed)
- The use of systemic antibiotics within 30 days of study start
- the use of topical medications within 14 - 30 days of study start depending on type of topical medication
- Patients with known sensitivity to tetracyclines
- Patients who have had gastric bypass surgery or are considered achlorhydric
- Patients taking drugs known as photosensitizers
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 |
|---|---|---|
| Minocycline 45 MGAlso: Solodyn45 mg oral minocyclineonce daily vs 45mg oral minocycline once daily in combination with use of 15% azelaic acid | Drug | azelaic acid, minocycline, azelaic acid |
| Azelaic acidAlso: finacea45 mg oral minocyclineonce daily vs 45mg oral minocycline once daily in combination with use of 15% azelaic acid | Drug | azelaic acid, minocycline, azelaic acid |
Primary outcome
Efficacy analysis of the 12-week reduction in total lesion count
Time frame: 12 weeks
The goal of analysis is to assess evidence of overall effect of 45mg minocycline and overall effect of 45 mg minocycline plus 15% azelaic acid in therapy of patients with acne rosacea.
2 secondary outcomes
Efficacy analysis of the12 week reduction in IGA (Investigators Global Assessment) per treatment group
Time frame: 12 Weeks
Efficacy analysis of the 12-week reduction in CEA (Clinical Erythema Assessment) per treatment group
Time frame: 12 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2021.
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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.
James M Jackson, MD principal investigator
Dermatology Specialists
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Minocycline 45 MG and Azelaic acid in people with Rosacea, run by Dermatology Specialists Research at 1 site in United States.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 20 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Efficacy analysis of the 12-week reduction in total lesion count (time frame: 12 weeks). 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 20 Aug 2021.