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

NCT01308619 | Completed Phase 4 Results

• 1 other identifier: US10150
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 10

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.

Conditions

Rosacea

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Inflammatory Lesion Counts

  Mean change in inflammatory lesion counts from baseline to week 12

  baseline to week 12

Secondary Outcomes (3)

• Change From Baseline in Biochemical Markers of Rosacea From Tape Stripping and/or Skin Biopsy From Baseline to Week 12

  baseline to week 12

• Investigator's Global Assessment (IGA) Scores at Week 12

  Week 12

• Change From Baseline in Clinician's Erythema Assessment (CEA) Scores

  baseline to week 12

Study Arms (2)

Oracea®

ACTIVE COMPARATOR

Doxycycline 40 mg (30 mg immediate release / 10 mg delayed release beads) Capsules

Drug: Doxycycline

placebo

ACTIVE COMPARATOR

placebo

Other: Placebo

Interventions

Doxycycline DRUG

doxycycline 40 mg (30 mg immediate release / 10 mg delayed release beads) Capsules, oral, one capsule daily in the morning

Also known as: Oracea®

Oracea®

Placebo OTHER

Placebo, oral, one capsule daily in the morning

placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (10)

Burke Pharmaceutical Research

Hot Springs, Arkansas, 71913, United States

Location

Therapeutics Clinical Research

San Diego, California, 92123, United States

Location

Hudson Dermatology

Evansville, Indiana, 47714, United States

Location

The Indiana Clinical Trials Center

Plainfield, Indiana, 46168, United States

Location

Michigan Center for Research Corp

Clinton Township, Michigan, 48038, United States

Location

Skin Search of Rochester, Inc

Rochester, New York, 14623, United States

Location

Oregon Medical Research Center, PC

Portland, Oregon, 97223, United States

Location

Derm Research

Austin, Texas, 78759, United States

Location

J & S Studies, Inc.

College Station, Texas, 77845, United States

Location

Suzanne Bruce and Associates, PA

Houston, Texas, 77056, United States

Location

MeSH Terms

Conditions

Rosacea

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Warren Winkelman
• Organization: Galderma Laboratories

warren.winkelman@galderma.com

817-961-5494

Study Officials

• Ronald W Gottschalk, MD

  Galderma R&D

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2011
• First Posted: March 4, 2011
• Study Start: April 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: August 1, 2022
• Results First Posted: August 5, 2014

Record last verified: 2014-07

Locations

US (10)