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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

NCT01320033 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 662

Last updated 2021-02-18

Study results available
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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.

Conditions

  • Acne Vulgaris

Interventions

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.

Sponsors & Collaborators

  • Galderma R&D

    lead INDUSTRY

Principal Investigators

  • Michael Graeber, MD · Galderma R&D

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-29
Primary Completion
2012-01-03
Completion
2012-01-03

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01320033 on ClinicalTrials.gov