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NCT00417937 Clinical Trial

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

Papulopustular Rosacea Clinical Trial

Official title:
A Multicenter, Double-Blind Clinical Trial to Assess the Efficacy and Tolerability of Topical Azelaic Acid 15% Gel Once Daily Compared to Topical Azelaic Acid 15% gelTwice Daily in Subjects With Papulopustular Rosacea

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00417937
Other study ID # 14428
Secondary ID 1401460
Status Completed
Phase Phase 4
First received
Last updated
Start date January 2007
Est. completion date June 2007

Study information
Verified date February 2014
Source LEO Pharma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 98
Est. completion date June 2007
Est. primary completion date June 2007
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• azelaic acid 15% gel
15% gel, topically applied once daily for six weeks
• azelaic acid 15% gel
15% gel, topically applied twice daily for six weeks

Locations
Country Name City State
Germany Intendis GmbH Berlin

Sponsors (2)
Lead Sponsor Collaborator
LEO Pharma Bayer

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Investigator's global assessment scored on a seven point scale Measurements made during the course of treatment
Secondary Inflammatory lesion count, erythema, telangiectasia, patient self assessment, patient opinion about therapy Parameters measured during the course of treatment
See also
  Status Clinical Trial Phase
Completed NCT03276936 - A Study to Evaluate the Long-Term Safety of Topical Administration of FMX103 in the Treatment of Moderate to Severe Papulopustular Rosacea Phase 3
Completed NCT02601963 - Safety and Efficacy Study of a Topical Minocycline Foam in Patients With Papulopustular Rosacea Phase 2
Completed NCT02268474 - Excel V 532 nm KTP Laser for Treatment of Erythematotelangiectatic Rosacea & Papulopustular Rosacea N/A
Completed NCT01555463 - Safety and Efficacy of Azelaic Acid Foam, 15 % in Papulopustular Rosacea Phase 3
Active, not recruiting NCT03667222 - Topical Minocycline Gel for Inflammatory Lesions of Papulopustular Rosacea Phase 2
Terminated NCT03564145 - A Long-Term Safety Study of S5G4T-1 in the Treatment of Papulopustular Rosacea Phase 3
Completed NCT05150587 - Safety, Efficacy and Pharmacokinetics of Rifaximin in Patients With Moderate-to-severe Papulopustular Rosacea Phase 2
Completed NCT03263273 - Study to Evaluate the Safety and Efficacy of Topical Minocycline Gel in Patients With Papulopustular Rosacea Phase 2
Completed NCT05343455 - A Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Capsules for the Treatment of Rosacea (MVOR-2) Phase 3
Completed NCT01784133 - A Twelve Week Safety and Efficacy Study in Rosacea Phase 2
Completed NCT01872715 - Patient Centered Outcomes in Rosacea: An Exploratory Multi-media Analysis of the Patient Experience on Oracea Phase 4
Completed NCT05296629 - A Randomized, Double-Blind Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Capsules for the Treatment of Rosacea. Phase 3
Completed NCT05838170 - Study of TP-04 in Participants With Papulopustular Rosacea Phase 2
Recruiting NCT06013371 - PDE4 Inhibition in Seborrheic Dermatitis and Papulopustular Rosacea Phase 2
Recruiting NCT03864978 - Safety and Efficacy of Rifaximin in Patients With Papulopustular Rosacea and Positive Lactulose Breath Test Phase 2
Completed NCT03564119 - A Study of S5G4T-1 in the Treatment of Papularpustular Rosacea Phase 3
Completed NCT03079531 - Open Label Study to Assess the Effect of Secukinumab in Moderate to Severe Papulopustular Rosacea Phase 1/Phase 2
Completed NCT01045551 - Open Label Pilot Study of Apremilast in Treatment of Rosacea Phase 2
Completed NCT03448939 - A Study of S5G4T-1 in the Treatment of Papulopustular Rosacea Phase 3
Completed NCT05675501 - Evaluation of Topical Encapsulated Benzoyl Peroxide on the Skin Microbiome and Skin Biophysical Properties Phase 1