Evaluation of Rosacea-related Inflammatory Biochemical Markers in Adult Skin When Treated With Oracea® vs Placebo

Phase 4

Completed

Conditions: Rosacea

Interventions: Other: Placebo
Drug: Doxycycline

Registration Number: NCT01308619

Lead Sponsor: Galderma R&D

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 170

Inclusion Criteria

Subject is male or female aged 18 to 70 years inclusive
Subject with papulopustular rosacea (5 to 40 papules or pustules)

Exclusion Criteria

Subject has any other active dermatological condition on face that may interfere with the conduct of the study
Subject uses proton pump inhibitors for treatment of gastroesophageal reflux within 30 days prior to baseline visit or during the study
Subject uses spironolactone within 30 days prior to baseline visit or during the study
Subject requires chronic treatment (>14 days) with sulfa drugs, erythromycin, cephalosporins and quinolones within 30 days prior to baseline visit or during the study
Subject has used tetracycline antibiotics within 30 days prior to baseline visit or during the study
Subject has used penicillin antibiotics within 30 days prior to baseline visit or during the study
Subject uses topical or oral dapsone
Subject has had a change in hormonal therapy within 3 months of initiation of therapy or during the study
Subject has used systemic immunosuppressants (e.g. corticosteroids, cyclosporine, imuran, biologics, mycophenolate mofetil) within 30 days prior to baseline visit. For subjects who have received treatment with biologics, treatment must have been discontinued within 90 days prior to baseline
Subject has used any systemic therapy directed at improving rosacea, including antibiotics, within 30 days prior to baseline visit
Subject has used systemic retinoids within 6 months of the baseline visit
Subject takes niacin at a dosage of 500 mg or more per day
Subject has used any topical rosacea therapy including topical antibiotics, topical retinoids, topical sodium sulfacetamide preparations, topical benzoyl peroxides, topical vasoconstricting agents (e.g., oxymetazoline) topical calcineurin inhibitors (e.g. tacrolimus, pimecrolimus) within 30 days prior to baseline visit
Subject has been treated with another investigational drug or device within 30 days of baseline visit. For subjects who received experimental biologic treatment, treatment must have been discontinued within five half lives of the baseline visit.
Subject has a known allergy to any of the components of the study products, and/or a known hypersensitivity to tetracyclines
Subject is using a clinically significant concomitant drug (e.g., use of long term non-steroidal anti-inflammatory agents unless used only on a PRN basis less than 7 days per month)
Subject has used vasodilators or an adrenergic blocking agent within 6 weeks of baseline visit (except subjects on stable dose for greater than 3 months)
Subject has had laser or light therapy on the face within 3 months of the baseline visit
Subject with active ocular rosacea and/or blepharitis/meibomianitis requiring systemic treatment by an ophthalmologist
Subject with rhinophymatous rosacea
Subject with a history of noncompliance with a treatment regimen
Subject is at risk in terms of precautions, warnings, and contraindications (see package insert)
Subject has previously failed to have improvement of rosacea with appropriate use of systemic tetracycline family of antibiotics
Subjects with a recent history of alcohol and/or drug abuse

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	placebo
Oracea®	Doxycycline	Doxycycline 40 mg (30 mg immediate release / 10 mg delayed release beads) Capsules

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Inflammatory Lesion Counts	baseline to week 12	Mean change in inflammatory lesion counts from baseline to week 12

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Biochemical Markers of Rosacea From Tape Stripping and/or Skin Biopsy From Baseline to Week 12	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.
Investigator's Global Assessment (IGA) Scores at Week 12	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.
Change From Baseline in Clinician's Erythema Assessment (CEA) Scores	baseline to week 12	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.

Trial Locations

Locations (10): Michigan Center for Research Corp
🇺🇸
Clinton Township, Michigan, United States
Burke Pharmaceutical Research
🇺🇸
Hot Springs, Arkansas, United States
Oregon Medical Research Center, PC
🇺🇸
Portland, Oregon, United States
Therapeutics Clinical Research
🇺🇸
San Diego, California, United States
Hudson Dermatology
🇺🇸
Evansville, Indiana, United States
The Indiana Clinical Trials Center
🇺🇸
Plainfield, Indiana, United States
J & S Studies, Inc.
🇺🇸
College Station, Texas, United States
Skin Search of Rochester, Inc
🇺🇸
Rochester, New York, United States
Suzanne Bruce and Associates, PA
🇺🇸
Houston, Texas, United States
Derm Research
🇺🇸
Austin, Texas, United States