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Acne RosaceaPhase 4NCT02147691

Finacea 15% and Brimonidine 0.33% Gel in the Treatment of Rosacea - A Pilot Study

A Phase 4 study testing Azelaic acid 15% and Brimonidine 0.33% in people with Acne Rosacea, run by Derm Research, PLLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The pilot study will investigate whether combination treatment of Finacea 15% Gel and Brimonidine 0.33% Gel could be more effective than Brimonidine 0.33% Gel monotherapy in treating both the papules/pustules and erythema associated with rosacea. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Acne Rosacea
What is being tested?
Azelaic acid 15% and Brimonidine 0.33%
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteUnited States
Study dates
May 2014to Feb 2015
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or Female
  • 18 years of age and older
  • Female subjects of childbearing potential must have a negative urine pregnancy test at Baseline
  • Female subjects of childbearing potential must practice a reliable method of contraception throughout the study
  • Moderate or severe rosacea with an Investigator Global Assessment (IGA) score of 3 or 4
  • Able to understand and comply with the requirements of the study and sign Informed Consent/Health Insurance Portability and Accountability Authorization forms

Who cannot join

  • Female subjects who are pregnant, breast feeding or who are of childbearing potential and not practicing a reliable method of birthcontrol
  • History of hypersensitivity or idiosyncratic reaction to any component of the test medications
  • Subjects who have not completed the proper wash-out periods for prohibited medications and/or procedures
  • Medical condition that contraindicates the subject's participation in the study
  • Alcohol or drug abuse is evident within the past 5 years
  • History of poor cooperation, non-compliance with medical treatment, unreliability
  • Participation in an investigational drug study within 30 days of the Baseline visit

Trial locations and contacts

1 site in 1 country.

United States1 site

  • DermResearch, PLLC

    Louisville, Kentucky, 40217

Other trials in United States

About this study

The pilot study will investigate whether combination treatment of Finacea 15% Gel and Brimonidine 0.33% Gel could be more effective than Brimonidine 0.33% Gel monotherapy in treating both the papules/pustules and erythema associated with rosacea.

Read the detailed description

Acne rosacea is a chronic inflammatory disease with different components including inflammatory lesions (papules/pustules), erythema and telangiectasia. Brimonidine 0.33% Gel primarily affects the erythematous components of rosacea. As such, combination treatment with a standard rosacea treatment, such as Finacea 15% Gel, may provide additional relief for the inflammatory component of rosacea.

Conditions
Acne Rosacea
Being tested
Azelaic acid 15%, Brimonidine 0.33%
Medical subject headings
Rosacea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Azelaic acid 15%Drug

    Also called Finacea

    Applied to the face each AM and PM

  • Brimonidine 0.33%Drug

    Also called Miravaso

    Applied to the face each AM 30 minutes after the application of Azelaic acid 15%

Study groups in NCT02147691
Study groupRoleWhat they receive
Azelaic acid 15%, Brimonidine 0.33 % GelExperimentalAzelaic acid 15% to the face each AM followed 30 minutes later by Brimonidine 0.33% Azelaic acid 15% to the face each PM
Receives: Drug: Azelaic acid 15%; Drug: Brimonidine 0.33%
Brimonidine 0.33% GelActive comparatorBrimonidine 0.33% Gel
Receives: Drug: Brimonidine 0.33%

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Investigator Global Assessment (IGA) at Baseline

    Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe

    Measured: Baseline

  2. IGA

    Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe

    Measured: Week 4

  3. IGA

    Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe

    Measured: Week 8

  4. IGA

    Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe

    Measured: Week 12

Secondary outcomes (16)

  1. Lesion Counts

    The number of inflammatory lesions (papules/pustules) will be counted using the whole face from the hairline edge to the mandibular line

    Measured: Baseline

  2. Clinician's Erythema Assessment

    Erythema will be graded on a scale of 0-4., 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 very severe. If erythema is much worse on one or several parts of the face, the grade for the worst area will be captured.

    Measured: Baseline

  3. Erythema Visual Analog Scale (VAS) Assessment (Subject)

    Subjects will self assess the level of erythema over the previous 24 period using a scale of None (0) through 10 (Unbearable)

    Measured: Baseline

  4. Dermatology Life Quality Index (DLQI)

    The DLQI is a self-administered questionnaire consisting of 10 questions that measure how much the individual's skin problem has affected their life in the past week. Score ranges 0 through 30, 0 being none and 30 worst possible.

    Measured: Baseline

  5. Lesion Count

    Measured: Week 4

  6. Lesion Counts

    Measured: Week 8

  7. Lesion Counts

    Measured: Week 12

  8. Erythema

    Erythema as measured by the clinician on a scale of 0-4, 0 = no erythema, 1 = slight pinkness, 2 = moderate, definite redness, easily recognized, 3 = severe, marked erythema and 4 = very severe, fiery red

    Measured: Week 4

  9. Erythema

    Erythema as measured by the clinician on a scale of 0-4, 0 = no erythema, 1 = slight pinkness, 2 = moderate, definite redness, easily recognized, 3 = severe, marked erythema and 4 = very severe, fiery red

    Measured: Week 8

  10. Erythema

    Erythema as measured by the clinician on a scale of 0-4, 0 = no erythema, 1 = slight pinkness, 2 = moderate, definite redness, easily recognized, 3 = severe, marked erythema and 4 = very severe, fiery red

    Measured: Week 12

  11. Visual Analog Scale (VAS)

    participant measures erythema on a scale of 0 mm to 10 mm with 0 = to none and 10 = unbearable

    Measured: Week 4

  12. VAS

    participant measures erythema on a scale of 0 mm to 10 mm with 0 = to none and 10 = unbearable

    Measured: Week 8

  13. VAS

    participant measures erythema on a scale of 0 mm to 10 mm with 0 = to none and 10 = unbearable

    Measured: Week 12

  14. Dermatology Life Quality Index (DLQI)

    Total scores range from 0 ( no impact on life over the last week) to 30 (maximum impact on life over the last week)

    Measured: Week 4

  15. DLQI

    Total scores range from 0 ( no impact on life over the last week) to 30 (maximum impact on life over the last week)

    Measured: Week 8

  16. DLQI

    Total scores range from 0 ( no impact on life over the last week) to 30 (maximum impact on life over the last week)

    Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2014 (estimated)
  2. Study startMay 2014
  3. Primary completionJan 2015
  4. Study completionFeb 2015

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02147691
Sponsor's protocol ID
FIN1302
Status last verified
Aug 2015
First submitted
16 May 2014
Last updated
30 Sep 2015
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Azelaic acid 15% and Brimonidine 0.33% in people with Acne Rosacea, run by Derm Research, PLLC 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 6 inclusion and 7 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 30 Sep 2015. 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?

Yes. Results are posted in the registry (first posted 30 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Investigator Global Assessment (IGA) at Baseline (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02147691.

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 30 Sep 2015.

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