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

LEO Pharma

Status and phase: Completed; Phase 1

Conditions: Papulopustular Rosacea

Treatments: Drug: Azelaic Acid Gel; Drug: Azelaic Acid Foam

Study type: Interventional

Funder types: Industry

Identifiers

NCT01257919

1401843 (Other Identifier)

15386

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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21 participants in 2 patient groups

Azelaic Acid Foam 15%

Experimental group

Description:

Dermal application of Azelaic Acid Foam 15%

Treatment:

Drug: Azelaic Acid Foam

Azelaic Acid Gel 15%

Active Comparator group

Description:

Dermal application of Azelaic Acid Gel 15%

Treatment:

Drug: Azelaic Acid Gel