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Papulopustular RosaceaPhase 2NCT00617903

Exploration of Safety and Efficacy of AzA 15% Foam Twice a Day in Rosacea

A Phase 2 study testing Azelaic acid in people with Papulopustular Rosacea, run by LEO Pharma at 7 sites 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

This exploratory study is being performed to determine whether a new form formulation of azelaic acid 15% is effective in the treatment of papulopustular rosecea. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Papulopustular Rosacea
What is being tested?
Azelaic acid
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
83 participants
Where
7 sitesUnited States
Study dates
Jan 2008to Jun 2008
Phase
Phase 2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • male and female patient at least 18 years of age
  • signed informed consent
  • Papulopustular rosacea with a minimum of 10 and a maximum of 50 papules and/or pustules, persistent erythema, and telangiectasia
  • Ability and willingness to accept and comply with treatment and required medical examinations

Who cannot join

  • Known non-responders to azelaic acid
  • Erythematotelangiectatic, rhinophymatous, ocular, or steroid rosacea
  • Presence of dermatoses that could interfere with the rosacea diagnosis
  • Treatment with isotretinoin in the six months prior to randomization
  • Treatment of the face with topical retinoids during the two weeks prior to randomization
  • Treatment with oral antibiotics during the four weeks prior to randomization
Show all 16Show fewer
  • Treatment with topical antibiotics
  • Treatment with systemic corticosteroids during 4 weeks prior to randomization
  • Treatment of the face with topical corticosteroids during 2 weeks prior to randomization
  • Treatment of the face with topical imidazole antimycotics during 2 weeks prior to randomization
  • Treatment of the face with topical azelaic acid formulations during 2 weeks prior to randomization
  • Use of a sauna during 2 weeks prior to randomization and during the study
  • Facial laser surgery for telangiectasia during 6 weeks prior to randomization
  • Planned concurrent use of any treatment other than study medication that affects rosacea
  • History of hypersensitivity to propylene glycol or any other ingredient of the study drugs
  • Participation in another clinical trial during the last 4 weeks

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Study site

    Albuquerque, New Mexico, 87106

  • Study site

    Austin, Texas, 78759

  • Study site

    Denver, Colorado, 80209

  • Study site

    Henderson, Nevada, 89052

  • Study site

    Mason, Ohio, 45040

  • Study site

    Norfolk, Virginia, 23507

  • Study site

    Olathe, Kansas, 66062

Other trials in United States

About this study

Official title: A 12-week Exploratory, Multicenter, Double-blind, Vehicle-controlled Study to Investigate the Efficacy and Safety of Topical Azelaic Acid 15% Foam Twice Daily in Patients With Papulopustular Rosacea

This exploratory study is being performed to determine whether a new form formulation of azelaic acid 15% is effective in the treatment of papulopustular rosecea.

Being tested
Azelaic acid, Vehicle foam
Keywords
rosacea, papulopustular, azelaic acid, foam
Medical subject headings
Rosacea

What participants receive

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

  • Azelaic acidDrug

    15% foam to be applied topically twice daily

  • Vehicle foamDrug

    Active-ingredient-free vehicle to be applied topically twice daily

Study groups in NCT00617903
Study groupRoleWhat they receive
Azelaic acid foam, 15% (BAY39-6251)ExperimentalParticipants received azelaic acid foam, 15% topically twice daily for 12 weeks
Receives: Drug: Azelaic acid
Vehicle foamPlacebo comparatorParticipants received vehicle foam topically twice daily for 12 weeks
Receives: Drug: Vehicle foam

What is being measured

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

  1. Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) Per Participant at End of Study (LOCF: Last Observation Carried Forward)

    Measured: Baseline and End of Study (Week 12)

  2. Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at End of Study (LOCF)

    IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success is defined as an IGA score of clear or minimal (0 to 1).

    Measured: At End of Study (Week 12)

  3. Grouped Change From Baseline in Erythema Intensity Score at End of Study (LOCF)

    Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe

    Measured: Baseline and End of Study (Week 12)

Secondary outcomes (16)

  1. Mean of Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF)

    Measured: At Weeks 4, 8, 12 and End of Study (LOCF)

  2. Nominal Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8 and 12

    Measured: Baseline and Weeks 4, 8 and 12

  3. Percent Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF)

    Measured: Baseline and Weeks 4, 8, 12 and End of Study (LOCF)

  4. Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)

    IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success is defined as an IGA score of clear or minimal (0 to 1).

    Measured: At Weeks 4, 8, 12 and End of Study (LOCF)

  5. Change From Baseline in IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)

    IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success is defined as an IGA score of clear or minimal (0 to 1).

    Measured: Baseline and Weeks 4, 8, 12 and End of Study (LOCF)

  6. Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)

    Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe

    Measured: At Weeks 4, 8, 12 and End of Study (LOCF)

  7. Change From Baseline in Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)

    Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe

    Measured: Baseline and Weeks 4, 8, 12 and End of Study (LOCF)

  8. Grouped Change From Baseline in Erythema Intensity Score at Weeks 4, 8 and 12

    Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe

    Measured: Baseline and Weeks 4, 8 and 12

  9. Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)

    Telangiectasia intensity score: 1 - None; 2 - Mild; 3 - Moderate; 4 - Severe

    Measured: At Weeks 4, 8, 12 and End of Study (LOCF)

  10. Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)

    Telangiectasia intensity score: 1 - None; 2 - Mild; 3 - Moderate; 4 - Severe

    Measured: Baseline and Weeks 4, 8, 12 and End of Study (LOCF)

  11. Grouped Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)

    Telangiectasia intensity score: 1 - None; 2 - Mild; 3 - Moderate; 4 - Severe

    Measured: Baseline and Weeks 4, 8, 12 and End of Study (LOCF)

  12. Investigator's Rating of Overall Improvement at End of Study

    Investigator's rating of overall improvement: 1 - excellent improvement; 2 - marked improvement; 3 - moderate improvement; 4 - no change; 5 - deterioration

    Measured: At End of Study (Week 12)

  13. Patients' Rating of Overall Improvement at End of Study

    Patient's rating of overall improvement: 1 - excellent; 2 - good; 3 - fair; 4 - no improvement; 5 - worse

    Measured: At End of Study (Week 12)

  14. Patients' Opinion on Cosmetic Acceptability at End of Study

    Patient's opinion on cosmetic acceptability: 1 - very good; 2 - good; 3 - satisfactory; 4 - poor; 5 - no opinion

    Measured: At End of Study (Week 12)

  15. Percentage of Participants With IGA Based Therapeutic Success at Weeks 4, 8 and 12

    IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success was defined as an IGA score of clear or minimal (0 to 1).").

    Measured: At Weeks 4, 8 and 12

  16. Percentage of Participants With IGA Based Patient Response at Weeks 4, 8, 12 and End of Study (LOCF)

    IGA based Patient response was defined as an IGA score of clear, minimal or mild (0, 1, 2).

    Measured: At Weeks 4, 8, 12 and End of Study (LOCF)

Timeline

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

  1. First posted18 Feb 2008 (estimated)
  2. Study startJan 2008
  3. Primary completionJun 2008
  4. Study completionJun 2008

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
83 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00617903
Sponsor's protocol ID
1402140
Status last verified
Dec 2013
First submitted
22 Jan 2008
Last updated
7 Apr 2020
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Azelaic acid in people with Papulopustular Rosacea, run by LEO Pharma at 7 sites 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 4 inclusion and 16 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 7 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 4 Jul 2013). 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?

Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) Per Participant at End of Study (LOCF: Last Observation Carried Forward) (time frame: Baseline and End of Study (Week 12)). The study lists 3 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 NCT00617903.

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 7 Apr 2020.

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