The benefit of a formulation of azelaic acid 15% and a complex of active ingredients for the treatment of papulopustular rosacea

Evaluating the Efficacy of a Novel Dermocosmetic Cream with 15% Azelaic Acid and Active Ingredients Complex, Presenting Soothing and Non-Irritant Properties, in Treating Papulopustular Rosacea: Results from a Randomized Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN10669312

Enrollment

Registered

2023-01-16

Start date

2018-10-01

Completion date

Unknown

Last updated

2024-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Papulopustular rosacea phenotype Skin and Connective Tissue Diseases

Interventions

This study is a 12-week, double-blind, vehicle-controlled, parallel-assigned-group, randomized clinical trial performed in one centre in Colombia enrolling subjects with papulopustular rosacea randoml

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male or female subjects aged 18 years and older 2. Clinical diagnosis of papulopustular rosacea (PPR) phenotype with at least 10 inflammatory lesions

Exclusion criteria

Exclusion criteria: 1. Pregnant or nursing woman 2. Subjects with rosacea of predominant phenotypes different from the phenotype of papules and pustules 3. Subjects with concomitant dermatoses that might interfere with the evaluation of lesions 4. Concomitant use of oral antibiotics and/or oral isotretinoin 5. Contraindications for the use of azelaic acid or metronidazole

Design outcomes

Primary

Measure	Time frame
Current primary outcome measure as of 25/07/2024: Outcomes assessed at each study visit at baseline, and weeks 4, 8 and 12: 1. Number of inflammatory papules and pustules on the forehead, nose, both left and right cheek and chin counted by the investigator and recorded in the study records 2. Investigator global assessment (IGA) score measured using a 7-point static scoring system: (0: clear; 1: minimal; 2: mild; 3: mild to moderate; 4: moderate; 5: moderate to severe; 6: severe). 3. Global improvement in erythema severity measured using the Clinical Erythema Severity Score (ESS) on a 3-point scale ranging from 0: mild to 2: severe 5. Secondary symptoms assessment for the following clinical signs: burning, itching, and dryness measured using a 4-point scale (0: none to 3: severe) _____ Previous primary outcome measure: Outcomes assessed at each study visit at baseline, and weeks 4, 8 and 12: 1. Number of inflammatory papules and pustules on the forehead, nose, both left and right cheek and chin counted by the investigator and recorded in the study records 2. Investigator global assessment (IGA) score measured using a 7-point static scoring system: (0: clear; 1: minimal; 2: mild; 3: mild to moderate; 4: moderate; 5: moderate to severe; 6: severe). 3. Global improvement in erythema severity measured using the Clinical Erythema Severity Score (ESS) on a 3-point scale ranging from 0: mild to 2: severe 4. Incidence of adverse events (AEs) reported by the investigator and recorded in the study records 5. Cutaneous tolerability for the following clinical signs: burning, itching, and dryness measured using a 4-point scale (0: none to 3: severe)	—

Measure

Time frame

Current primary outcome measure as of 25/07/2024: Outcomes assessed at each study visit at baseline, and weeks 4, 8 and 12: 1. Number of inflammatory papules and pustules on the forehead, nose, both left and right cheek and chin counted by the investigator and recorded in the study records 2. Investigator global assessment (IGA) score measured using a 7-point static scoring system: (0: clear; 1: minimal; 2: mild; 3: mild to moderate; 4: moderate; 5: moderate to severe; 6: severe). 3. Global improvement in erythema severity measured using the Clinical Erythema Severity Score (ESS) on a 3-point scale ranging from 0: mild to 2: severe 5. Secondary symptoms assessment for the following clinical signs: burning, itching, and dryness measured using a 4-point scale (0: none to 3: severe) _____ Previous primary outcome measure: Outcomes assessed at each study visit at baseline, and weeks 4, 8 and 12: 1. Number of inflammatory papules and pustules on the forehead, nose, both left and right cheek and chin counted by the investigator and recorded in the study records 2. Investigator global assessment (IGA) score measured using a 7-point static scoring system: (0: clear; 1: minimal; 2: mild; 3: mild to moderate; 4: moderate; 5: moderate to severe; 6: severe). 3. Global improvement in erythema severity measured using the Clinical Erythema Severity Score (ESS) on a 3-point scale ranging from 0: mild to 2: severe 4. Incidence of adverse events (AEs) reported by the investigator and recorded in the study records 5. Cutaneous tolerability for the following clinical signs: burning, itching, and dryness measured using a 4-point scale (0: none to 3: severe)

—

Secondary

Measure	Time frame
Improvement in signs and symptoms of papulopustular rosacea phenotype measured using a self-assessment questionnaire with a 5-point scale (0: worse; 1: unchanged; 2: mild improvement; 3: moderate improvement; 4: great improvement) at week 12	—

Countries

Colombia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026