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COMPLETED Phase 2

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 · View on ClinicalTrials.gov ↗

Study 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 Studied

Interventions

  • DRUG Placebo
  • DRUG CD2475/101 40 mg
  • DRUG Doxycycline 100 mg

Study Locations (20)

Colorado

  • Colorado Medical Research Center — Denver
  • Longmont Medical Research Network — Longmont

Michigan

  • Somerset Skin Care Center — Troy
  • Grekin Skin Care — Warren

North Carolina

  • Dermatology Consulting Services — High Point
  • PMG Research of Wilmington — Wilmington

Arkansas

  • Burke Pharmaceutical Research — Hot Springs

California

  • Dermatology Research Associates, Inc. — Los Angeles

Florida

  • International Dermatology Research, Inc. — Miami

Georgia

  • MedaPhase, Inc. — Newnan

Kentucky

  • Dermatology Specialists PC — Louisville

Trial Details

FieldValue
Enrollment Target 662 participants
Start Date 2011-03-29
Est. Completion 2012-01-03
Phase Phase 2

Sponsor

Galderma R&D

49 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01320033

The ClinicalTrials.gov registry entry for NCT01320033 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 662 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Galderma R&D, which has 49 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Acne Vulgaris appearing as the primary indexed condition, and to 3 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01320033 reports 20 study locations spanning 17 distinct geographic areas — top geographies include Colorado, Michigan, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01320033 about?

NCT01320033 is a clinical study titled "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". 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.

What is the current status of trial NCT01320033?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 662 participants. The study started on 2011-03-29. Estimated completion is 2012-01-03.

What conditions does trial NCT01320033 study?

This clinical trial studies the following conditions: Acne Vulgaris. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01320033?

The interventions under investigation include: Placebo (DRUG), CD2475/101 40 mg (DRUG), Doxycycline 100 mg (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01320033?

This trial is sponsored by Galderma R&D, which has 49 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01320033 being conducted?

This trial has 20 study locations across Arkansas, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial