Clinical trial NCT01308619: Evaluation of Rosacea-related Inflammatory Biochemical Markers in Adult Skin When Treated With Oracea® vs Placebo
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Evaluation of Rosacea-related Inflammatory Biochemical Markers in the Skin of Adults With Papulopustular Rosacea Treated With Daily Doxycycline 40 mg (30 mg Immediate Release / 10 mg Delayed Release Beads) Capsules
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rosacea
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2011-03-04
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Inflammatory Lesion Counts
timeFrame: baseline to week 12
Secondary outcomes:
measure: Change From Baseline in Biochemical Markers of Rosacea From Tape Stripping and/or Skin Biopsy From Baseline to Week 12
timeFrame: baseline to week 12
measure: Investigator's Global Assessment (IGA) Scores at Week 12
timeFrame: Week 12
measure: Change From Baseline in Clinician's Erythema Assessment (CEA) Scores
timeFrame: baseline to week 12
Other outcomes:
Locations:
city: Hot Springs
country: United States
facility: Burke Pharmaceutical Research
state: Arkansas
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
city: Evansville
country: United States
facility: Hudson Dermatology
state: Indiana
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center
state: Indiana
city: Clinton Township
country: United States
facility: Michigan Center for Research Corp
state: Michigan
city: Rochester
country: United States
facility: Skin Search of Rochester, Inc
state: New York
city: Portland
country: United States
facility: Oregon Medical Research Center, PC
state: Oregon
city: Austin
country: United States
facility: Derm Research
state: Texas
city: College Station
country: United States
facility: J & S Studies, Inc.
state: Texas
city: Houston
country: United States
facility: Suzanne Bruce and Associates, PA
state: Texas
Study officials:
affiliation: Galderma R&D
name: Ronald W Gottschalk, MD
role: STUDY_DIRECTOR
References: