NCT01320033

Placebo Controlled Efficacy and Safety Study of CD2475/101 40 mg Tablets vs. Placebo and Doxycycline 100 mg Capsules Once Daily in the Treatment of Inflammatory Lesions of Acne Vulgaris

A Multi Center, Randomized, Double Blind, Placebo Controlled, 3 Arm, Parallel Group Study Comparing the Efficacy and Safety of CD2475/101 40 mg Tablets Versus Placebo and Doxycycline 100 mg Capsules Once Daily in the Treatment of Inflammatory Lesions in Subjects With Acne Vulgaris

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 662 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The primary objectives of the study is to show CD2475/101 40mg tablets taken once a day for 16 weeks is superior to the placebo in Change from baseline to Week 16(Last Observation Carry Forward, Intent To Treat) in inflammatory lesion counts.

Detailed description

Investigator's global assessment and lesion count will be performed at each study visit.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	CD2475/101 40 mg	Participants receive 40 mg of CD2475/101 tablets once a day for 16 weeks.
DRUG	Doxycycline 100 mg	Participants receive 100 mg of Doxycycline capsule once a day for 16 weeks
DRUG	Placebo	Participants receive matching placebo tablet, matching placebo capsule once a day for 16 weeks.

Timeline

• Start date: 2011-03-29
• Primary completion: 2012-01-03
• Completion: 2012-01-03
• First posted: 2011-03-22
• Last updated: 2021-02-18
• Results posted: 2020-02-10

Locations

31 sites across 1 country: United States