A Multicenter Trial of a Topical Medication for Papulopustular Rosacea Applied Twice Daily Versus Once Daily

LEO Pharma

Status and phase: Completed; Phase 4

Conditions: Papulopustular Rosacea

Treatments: Drug: azelaic acid 15% gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00417937

14428

1401460 (Other Identifier)

Details and patient eligibility

About

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.

Full description

To test the efficacy and safety of once vs twice daily application of azelaic acid 15% gel on papulopustular rosacea

Enrollment: 98 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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98 participants in 2 patient groups

1

Active Comparator group

Description:

Azelaic acid 15 % gel once daily

Treatment:

Drug: azelaic acid 15% gel

Drug: azelaic acid 15% gel

2

Active Comparator group

Description:

Azelaic acid 15 gel twice daily

Treatment:

Drug: azelaic acid 15% gel

Drug: azelaic acid 15% gel