Papulopustular Rosacea
Conditions
Brief summary
To assess the efficacy and tolerability of azelaic acid 15% gel applied once daily versus twice daily in the treatment of patients with papulopustular rosacea.
Detailed description
To test the efficacy and safety of once vs twice daily application of azelaic acid 15% gel on papulopustular rosacea
Interventions
15% gel, topically applied once daily for six weeks
Sponsors
Bayer
LEO Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Papulopustular facial rosacea; minimum of 10, maximum of 50 inflamed papules and/or pustules
Exclusion criteria
* Mild or severe rosacea * Rosacea with marked ocular manifestations * Presence of dermatoses that could interfere with the rosacea diagnosis or evaluation of the study course * Wash out period required for patients treated prior to study with topical retinoids, oral antibiotics, topical antibiotics, systemic and topical corticosteroids, topical imidazole, laser surgery for telangiectasia * History of hypersensitivity to propylene glycol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Investigator's global assessment scored on a seven point scale | Measurements made during the course of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Inflammatory lesion count, erythema, telangiectasia, patient self assessment, patient opinion about therapy | Parameters measured during the course of treatment |
Countries
Germany
Outcome results
None listed