Safety and Pharmacokinetics of Azelaic Acid Foam, 15% in Papulopustular Rosacea
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ClinicalTrials.gov Identifier: NCT01257919 |
Recruitment Status :
Completed
First Posted : December 10, 2010
Last Update Posted : April 1, 2020
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Papulopustular Rosacea | Drug: Azelaic Acid Foam Drug: Azelaic Acid Gel | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 21 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Single (Investigator) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | January 2011 |
Actual Primary Completion Date : | March 2011 |
Actual Study Completion Date : | March 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: Azelaic Acid Foam 15%
Dermal application of Azelaic Acid Foam 15%
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Drug: Azelaic Acid Foam
Dermal application of Azelaic Acid Foam |
Active Comparator: Azelaic Acid Gel 15%
Dermal application of Azelaic Acid Gel 15%
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Drug: Azelaic Acid Gel
Dermal application of Azelaic Acid Gel |
- Baseline corrected area under the curve (AUC) [ Time Frame: 12 hours ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01257919
United States, Nevada | |
Novum Pharmaceutical Research Services of Nevada Inc. | |
Las Vegas, Nevada, United States, 89121 |
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | LEO Pharma |
ClinicalTrials.gov Identifier: | NCT01257919 |
Other Study ID Numbers: |
15386 1401843 ( Other Identifier: Company Internal ) |
First Posted: | December 10, 2010 Key Record Dates |
Last Update Posted: | April 1, 2020 |
Last Verified: | February 2014 |
Rosacea Skin Diseases Azelaic acid Antineoplastic Agents Dermatologic Agents |