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

LEO Pharma83 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Papulopustular Rosacea

Interventions

Azelaic acidDRUG

15% foam to be applied topically twice daily

Vehicle foamDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (7)

Unnamed facility

Denver, Colorado, United States

Unnamed facility

Olathe, Kansas, United States

Unnamed facility

Henderson, Nevada, United States

Unnamed facility

Albuquerque, New Mexico, United States

Outcomes

Primary Outcomes

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)

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).

Time frame: At End of Study (Week 12)

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

Time frame: Baseline and End of Study (Week 12)

Secondary Outcomes

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

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

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

Time frame: Baseline and Weeks 4, 8 and 12

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

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

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).

Data from ClinicalTrials.gov

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Unnamed facility

Mason, Ohio, United States

Unnamed facility

Austin, Texas, United States

Unnamed facility

Norfolk, Virginia, United States

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

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).

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

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

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

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

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

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

Time frame: Baseline and Weeks 4, 8 and 12

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

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

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

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

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

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

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

Time frame: At End of Study (Week 12)

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

Time frame: At End of Study (Week 12)

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

Time frame: At End of Study (Week 12)

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).").

Time frame: At Weeks 4, 8 and 12

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).

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