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Tetracycline Antibiotic

Oracea for Papulopustular Rosacea

Phase 4
Waitlist Available
Research Sponsored by Galderma Laboratories, L.P.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 2, 6, and 12
Awards & highlights
Drug Has Already Been Approved
All Individual Drugs Already Approved
Approved for 60 Other Conditions
No Placebo-Only Group
Pivotal Trial

Summary

The purpose of this study is to characterize rosacea patients', being treated with Oracea, perception through visual analog scale reporting.

Eligible Conditions
  • Papulopustular Rosacea

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 2, 6, and 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 2, 6, and 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Rosacea Score on the Visual Analog Scale
Secondary study objectives
Patient Global Assessment (PGA) of Rosacea Scores
Patient Satisfaction Question
Rosacea-Specific Quality of Life Index

Side effects data

From 2013 Phase 4 trial • 24 Patients • NCT01872715
13%
Vomiting
8%
Diarrhea
8%
Cough
100%
80%
60%
40%
20%
0%
Study treatment Arm
Oracea

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 60 Other Conditions
This treatment demonstrated efficacy for 60 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: OraceaExperimental Treatment1 Intervention
Oracea (doxycycline USP, 40mg\[30mg immediate release/ 10mg delayed release beads\] taken once daily in the morning on an empty stomach, one hour before meals or two hours after. Oral dose for 12 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Doxycycline
FDA approved

Find a Location

Who is running the clinical trial?

Galderma Laboratories, L.P.Lead Sponsor
48 Previous Clinical Trials
9,203 Total Patients Enrolled
Galderma R&DLead Sponsor
302 Previous Clinical Trials
60,663 Total Patients Enrolled
~2 spots leftby Nov 2025
Unbiased ResultsWe believe in providing patients with all the options.
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