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Safety and Pharmacokinetics of Azelaic Acid Foam, 15% in Papulopustular Rosacea

Investigator-blinded, Randomized, Cross-over, Multiple Dose Phase I Study on Safety and Pharmacokinetics of Topically Applied Azelaic Acid Foam, 15% Compared to Azelaic Acid Gel, 15% in Subjects With Papulopustular Rosacea

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01257919
Enrollment
21
Registered
2010-12-10
Start date
2011-01-31
Completion date
2011-03-31
Last updated
2023-06-09

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

Conditions

Papulopustular Rosacea

Brief summary

Assessment of pharmacokinetics of Azelaic Acid Foam after repeated skin application and in comparison to Azelaic Acid gel. Assessment of safety after repeated skin application.

Interventions

DRUGAzelaic Acid Foam

Dermal application of Azelaic Acid Foam

DRUGAzelaic Acid Gel

Dermal application of Azelaic Acid Gel

Sponsors

Bayer
CollaboratorINDUSTRY
LEO Pharma
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* diagnosis of moderate papulopustular rosacea * free of any clinically significant disease

Exclusion criteria

* body weight less than 50 or more than 130 kg * clinically significant disease which could interfere with the study

Design outcomes

Primary

MeasureTime frame
Baseline corrected area under the curve (AUC)12 hours

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026