Papulopustular Rosacea Clinical Trial
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
NCT number | NCT00617903 |
Other study ID # | 1402140 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | January 2008 |
Est. completion date | June 2008 |
Verified date | December 2013 |
Source | LEO Pharma |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 83 |
Est. completion date | June 2008 |
Est. primary completion date | June 2008 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 - 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
LEO Pharma | Bayer |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | Baseline and End of Study (Week 12) | ||
Primary | 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). | At End of Study (Week 12) | |
Primary | 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 | Baseline and End of Study (Week 12) | |
Secondary | Mean of Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF) | At Weeks 4, 8, 12 and End of Study (LOCF) | ||
Secondary | Nominal Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8 and 12 | Baseline and Weeks 4, 8 and 12 | ||
Secondary | Percent Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF) | Baseline and Weeks 4, 8, 12 and End of Study (LOCF) | ||
Secondary | 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). | At Weeks 4, 8, 12 and End of Study (LOCF) | |
Secondary | 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). | Baseline and Weeks 4, 8, 12 and End of Study (LOCF) | |
Secondary | 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 | At Weeks 4, 8, 12 and End of Study (LOCF) | |
Secondary | 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 | Baseline and Weeks 4, 8, 12 and End of Study (LOCF) | |
Secondary | 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 | Baseline and Weeks 4, 8 and 12 | |
Secondary | 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 | At Weeks 4, 8, 12 and End of Study (LOCF) | |
Secondary | 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 | Baseline and Weeks 4, 8, 12 and End of Study (LOCF) | |
Secondary | 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 | Baseline and Weeks 4, 8, 12 and End of Study (LOCF) | |
Secondary | 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 | At End of Study (Week 12) | |
Secondary | 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 | At End of Study (Week 12) | |
Secondary | 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 | At End of Study (Week 12) | |
Secondary | 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)."). | At Weeks 4, 8 and 12 | |
Secondary | 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). | At Weeks 4, 8, 12 and End of Study (LOCF) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03276936 -
A Study to Evaluate the Long-Term Safety of Topical Administration of FMX103 in the Treatment of Moderate to Severe Papulopustular Rosacea
|
Phase 3 | |
Completed |
NCT02601963 -
Safety and Efficacy Study of a Topical Minocycline Foam in Patients With Papulopustular Rosacea
|
Phase 2 | |
Completed |
NCT02268474 -
Excel V 532 nm KTP Laser for Treatment of Erythematotelangiectatic Rosacea & Papulopustular Rosacea
|
N/A | |
Completed |
NCT01555463 -
Safety and Efficacy of Azelaic Acid Foam, 15 % in Papulopustular Rosacea
|
Phase 3 | |
Active, not recruiting |
NCT03667222 -
Topical Minocycline Gel for Inflammatory Lesions of Papulopustular Rosacea
|
Phase 2 | |
Terminated |
NCT03564145 -
A Long-Term Safety Study of S5G4T-1 in the Treatment of Papulopustular Rosacea
|
Phase 3 | |
Completed |
NCT05150587 -
Safety, Efficacy and Pharmacokinetics of Rifaximin in Patients With Moderate-to-severe Papulopustular Rosacea
|
Phase 2 | |
Completed |
NCT03263273 -
Study to Evaluate the Safety and Efficacy of Topical Minocycline Gel in Patients With Papulopustular Rosacea
|
Phase 2 | |
Completed |
NCT05343455 -
A Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Capsules for the Treatment of Rosacea (MVOR-2)
|
Phase 3 | |
Completed |
NCT01784133 -
A Twelve Week Safety and Efficacy Study in Rosacea
|
Phase 2 | |
Completed |
NCT01872715 -
Patient Centered Outcomes in Rosacea: An Exploratory Multi-media Analysis of the Patient Experience on Oracea
|
Phase 4 | |
Completed |
NCT05296629 -
A Randomized, Double-Blind Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Capsules for the Treatment of Rosacea.
|
Phase 3 | |
Completed |
NCT05838170 -
Study of TP-04 in Participants With Papulopustular Rosacea
|
Phase 2 | |
Recruiting |
NCT06013371 -
PDE4 Inhibition in Seborrheic Dermatitis and Papulopustular Rosacea
|
Phase 2 | |
Recruiting |
NCT03864978 -
Safety and Efficacy of Rifaximin in Patients With Papulopustular Rosacea and Positive Lactulose Breath Test
|
Phase 2 | |
Completed |
NCT03564119 -
A Study of S5G4T-1 in the Treatment of Papularpustular Rosacea
|
Phase 3 | |
Completed |
NCT03079531 -
Open Label Study to Assess the Effect of Secukinumab in Moderate to Severe Papulopustular Rosacea
|
Phase 1/Phase 2 | |
Completed |
NCT01045551 -
Open Label Pilot Study of Apremilast in Treatment of Rosacea
|
Phase 2 | |
Completed |
NCT03448939 -
A Study of S5G4T-1 in the Treatment of Papulopustular Rosacea
|
Phase 3 | |
Completed |
NCT05675501 -
Evaluation of Topical Encapsulated Benzoyl Peroxide on the Skin Microbiome and Skin Biophysical Properties
|
Phase 1 |