The objective of this study is to determine the clinical effects of doxycycline 40 mg (30 mg immediate release and 10 mg delayed release beads) capsules (Oracea®) as compared to placebo in the skin of adults with papulopustular rosacea and to identify a correlation, if any, with rosacea-related inflammatory markers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
170
doxycycline 40 mg (30 mg immediate release / 10 mg delayed release beads) Capsules, oral, one capsule daily in the morning
Placebo, oral, one capsule daily in the morning
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States
Therapeutics Clinical Research
San Diego, California, United States
Hudson Dermatology
Evansville, Indiana, United States
Change From Baseline in Inflammatory Lesion Counts
Mean change in inflammatory lesion counts from baseline to week 12
Time frame: baseline to week 12
Change From Baseline in Biochemical Markers of Rosacea From Tape Stripping and/or Skin Biopsy From Baseline to Week 12
Mean change from baseline to week 12 in biochemical markers of rosacea and expression in skin samples. A biological marker is a substance used as an indicator of a biological state such as rosacea. Biochemical markers are serine protease activity and expression, metalloprotease activity and expression, and production of leucine leucine-37 \[LL-37\] peptide.
Time frame: baseline to week 12
Investigator's Global Assessment (IGA) Scores at Week 12
Number of participants in each category of the Investigator's Global Assessment (IGA) scores at week 12. Investigator's Global Assessment evaluates papules and pustules of rosacea on a scale from 0 - 4 (0 = Clear, 1 = Near Clear, 2 = Mild, 3 = Moderate and 4 = Severe) with 0 being best and 4 being worst.
Time frame: Week 12
Change From Baseline in Clinician's Erythema Assessment (CEA) Scores
Mean change in Clinician's Erythema Assessment (CEA) from baseline to week 12. Clinician's Erythema Assessment evaluates erythema on a scale from 0 - 4 (0 = None, 1 = Mild, 2 = Moderate, 3 = Significant and 4 = Severe) with 0 being best and 4 being worst.
Time frame: baseline to week 12
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The Indiana Clinical Trials Center
Plainfield, Indiana, United States
Michigan Center for Research Corp
Clinton Township, Michigan, United States
Skin Search of Rochester, Inc
Rochester, New York, United States
Oregon Medical Research Center, PC
Portland, Oregon, United States
Derm Research
Austin, Texas, United States
J & S Studies, Inc.
College Station, Texas, United States
Suzanne Bruce and Associates, PA
Houston, Texas, United States