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

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

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 Overview

• Status: Completed
• Conditions: Rosacea
• Intervention / Treatment: Drug: Doxycycline; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 170
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Burke Pharmaceutical Research
  • California
    • San Diego, California, United States, 92123
      • Therapeutics Clinical Research
  • Indiana
    • Evansville, Indiana, United States, 47714
      • Hudson Dermatology
    • Plainfield, Indiana, United States, 46168
      • The Indiana Clinical Trials Center
  • Michigan
    • Clinton Township, Michigan, United States, 48038
      • Michigan Center for Research Corp
  • New York
    • Rochester, New York, United States, 14623
      • Skin Search of Rochester, Inc
  • Oregon
    • Portland, Oregon, United States, 97223
      • Oregon Medical Research Center, Pc
  • Texas
    • Austin, Texas, United States, 78759
      • Derm Research
    • College Station, Texas, United States, 77845
      • J & S Studies, Inc.
    • Houston, Texas, United States, 77056
      • Suzanne Bruce and Associates, PA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Oracea®; Doxycycline 40 mg (30 mg immediate release / 10 mg delayed release beads) Capsules	Drug: Doxycycline; doxycycline 40 mg (30 mg immediate release / 10 mg delayed release beads) Capsules, oral, one capsule daily in the morning; Other Names: Oracea®
Active Comparator: placebo	Other: Placebo; Placebo, oral, one capsule daily in the morning

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Inflammatory Lesion Counts	Mean change in inflammatory lesion counts from baseline to week 12	baseline to week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	baseline to week 12

Collaborators and Investigators

• Sponsor: Galderma R&D

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: March 2, 2011
• First Submitted That Met QC Criteria: March 2, 2011
• First Posted (Estimate): March 4, 2011

Study Record Updates

• Last Update Posted (Actual): August 1, 2022
• Last Update Submitted That Met QC Criteria: July 28, 2022
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Rosacea; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Doxycycline
• Other Study ID Numbers: US10150