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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier:
NCT01308619
First received: March 2, 2011
Last updated: August 19, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Rosacea
Drug: Doxycycline
Other: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Galderma Laboratories, L.P.:

Primary Outcome Measures:
  • Change from baseline in inflammatory lesion counts [ Time Frame: baseline to week 12 ] [ Designated as safety issue: No ]
    Mean change in inflammatory lesion counts from baseline to week 12


Secondary Outcome Measures:
  • Change from baseline in biochemical markers of rosacea from tape stripping and/or skin biopsy from baseline to week 12 [ Time Frame: baseline to week 12 ] [ Designated as safety issue: No ]
    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 from baseline to week 12 [ Time Frame: baseline to week 12 ] [ Designated as safety issue: No ]
    Number of participants in each category of the Investigator's Global Assessment (IGA) scores at baseline and 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 [ Time Frame: baseline to week 12 ] [ Designated as safety issue: No ]
    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.


Enrollment: 170
Study Start Date: April 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Oracea®
Active Comparator: placebo
placebo
Other: Placebo
Placebo, oral, one capsule daily in the morning
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01308619

Locations
United States, Arkansas
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States, 71913
United States, California
Therapeutics Clinical Research
San Diego, California, United States, 92123
United States, Indiana
Hudson Dermatology
Evansville, Indiana, United States, 47714
The Indiana Clinical Trials Center
Plainfield, Indiana, United States, 46168
United States, Michigan
Michigan Center for Research Corp
Clinton Township, Michigan, United States, 48038
United States, New York
Skin Search of Rochester, Inc
Rochester, New York, United States, 14623
United States, Oregon
Oregon Medical Research Center, PC
Portland, Oregon, United States, 97223
United States, Texas
Derm Research
Austin, Texas, United States, 78759
J & S Studies, Inc.
College Station, Texas, United States, 77845
Suzanne Bruce and Associates, PA
Houston, Texas, United States, 77056
Sponsors and Collaborators
Galderma Laboratories, L.P.
Investigators
Study Director: Ronald W Gottschalk, MD Galderma Laboratories, L.P.
  More Information

No publications provided

Responsible Party: Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier: NCT01308619     History of Changes
Other Study ID Numbers: US10150
Study First Received: March 2, 2011
Last Updated: August 19, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Rosacea
Skin Diseases
Doxycycline
Doxycycline hyclate
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on April 16, 2014