Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01426269
Other study ID # US10183
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date September 2011
Est. completion date June 2013

Study information

Verified date July 2014
Source Galderma R&D
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess relapse, efficacy and safety in subjects with rosacea during long-term treatment with either Oracea® or placebo, after an initial 12-week regimen of Oracea® and MetroGel® 1%.


Description:

Adult subjects with moderate to severe papulopustular rosacea will receive Oracea® and MetroGel® 1% once daily during phase 1 (baseline to week 12) of the study. Subjects will be eligible to enter phase 2 of the study based upon improvements in the Investigator's Global Assessment (IGA) score. During phase 2, subjects will receive either Oracea® or placebo once daily for up to an additional 40 weeks. Subjects who relapse during phase 2 will be discontinued from the study.


Recruitment information / eligibility

Status Completed
Enrollment 235
Est. completion date June 2013
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Subject is male or female aged 18 to 80 years inclusive. - Subject with papulopustular rosacea (11 to 40 papules or pustules) and an IGA of moderate or severe. - For subjects using medications to treat a concurrent medical condition, type and dose must have been stable for at least 90 days prior to study entry. Exclusion Criteria: - Female subjects who are pregnant, nursing or planning a pregnancy during the study. - Subject has any other active dermatological condition on the face that may interfere with the conduct of the study. - Subject uses or has recently used any medication which may interfere with the absorption, distribution, or elimination of study medications, or may interfere with the assessments of efficacy or safety of the study medications. - Subject has a known allergy to any of the components of the study products, and/or a known hypersensitivity to tetracyclines or metronidazole.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Doxycycline
During phase 1 (baseline - week 12): Oracea (doxycycline 40 mg USP (30 mg immediate release & 10 mg delayed release beads)), oral, one capsule daily in the morning During phase 1 (baseline - week 12) and phase 2 (week 12 - week 52): Oracea (doxycycline 40 mg USP (30 mg immediate release & 10 mg delayed release beads), oral, one capsule daily in the morning
Metronidazole
During Phase 1: MetroGel 1% (metronidazole 1% gel), topical, apply a thin layer once daily to the affected area
Placebo
During phase 2 (week 12 - week 52): placebo, oral, one capsule daily in the morning

Locations

Country Name City State
United States Hilary Baldwin Brooklyn New York
United States Dadeland Dermatology Coral Gables Florida
United States Melissa L. F. Knuckles M.D., P.S.C. Corbin Kentucky
United States The Maryland Laser, Skin, and Vein Institute, LLC Hunt Valley Maryland
United States Dermatology Specialists Research Louisville Kentucky
United States Center for Dermatology and Laser Surgery Portland Oregon
United States Melissa L. F. Knuckles M.D., P.S.C. Richmond Kentucky
United States The Center for Dermatology at Linden Oaks Rochester New York
United States ATS Clinical Research Santa Monica California
United States Brodell Medical, Inc. Warren Ohio
United States Grekin Skin Institute Warren Michigan

Sponsors (1)

Lead Sponsor Collaborator
Galderma R&D

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Period 1: Tolerability (Scaling) Scaling, dryness, and stinging/burning were graded at baseline and weeks 4, 8, and 12 for subjects taking oral doxycycline and topical metronidazole. Period 1 (12 Weeks)
Other Period 1: Tolerability (Stinging/Burning) Scaling, dryness, and stinging/burning were graded at baseline and weeks 4, 8, and 12 for subjects taking oral doxycycline and topical metronidazole. Period 1 (12 Weeks)
Other Period 1: Tolerability (Dryness) Scaling, dryness, and stinging/burning were graded at baseline and weeks 4, 8, and 12 for subjects taking oral doxycycline and topical metronidazole. Period 1 (12 Weeks)
Primary Period 2: Number of Subjects Who Relapsed Subjects who relapsed during phase 2 were discontinued. Relapse was defined as meeting any one of the following criteria:
A return to the baseline lesion count
A return to the baseline IGA score
The investigator determines that a change in rosacea treatment is warranted due to the subject's clinical condition. The numbers reported here are accumulative numbers for each arm.
Period 2 (40 weeks)
Secondary Period 2: Investigator's Global Assessment Success The evaluator (investigator) assessed the severity of rosacea at baseline and each postbaseline visit using a 5 point Investigator's Global Assessment scale. Subjects scores were then dichotomized into success (clear or near clear score) or failure (mild, moderate, or severe score). Period 2 (40 weeks)
Secondary Period 2: Clinician's Erythema Assessment The evaluator (investigator) assessed the severity of erythema at baseline and each postbaseline visit using a total erythema score. The erythema of 5 areas of the face (forehead, chin, nose, right cheek, left cheek) was scored using a 5 point Clinician's Erythema Assessment scale (0 = none, 1 = mild, 2 = moderate, 3 = significant, 4 = severe). The total of the 5 individual erythema scores scores was the total erythema score. Period 2 (40 Weeks)
Secondary Period 2: Inflammatory Lesion Count The evaluator (investigator or a designee) performed lesion counts at each postbaseline visit. Period 2 (40 Weeks)
See also
  Status Clinical Trial Phase
Completed NCT05597462 - Impact of DFD-29 on Microbial Flora of Healthy, Adult Human Subjects When Administered Over 16 Weeks Phase 1
Completed NCT02601963 - Safety and Efficacy Study of a Topical Minocycline Foam in Patients With Papulopustular Rosacea Phase 2
Completed NCT02249065 - Mirvaso in Use Study Phase 4
Completed NCT02292797 - Assessment of the Rosacea Prevalence in the General Population N/A
Completed NCT01659853 - Efficacy and Safety Study Comparing CD07805/47 Gel 0.5% to Azelaic Acid Gel 15% in Subjects With Erythema of Rosacea Phase 3
Completed NCT00991198 - The Role of Topically Dissolved Oxygen (TDO) to Ameliorate Signs of Photodamage Phase 2
Terminated NCT04336163 - Skin Imaging to Inform Laser Treatments N/A
Recruiting NCT04108897 - Analysis of the Microbiome in Rosacea Early Phase 1
Completed NCT03872050 - Deep Phenotyping of Rosacea and Migraine
Active, not recruiting NCT06033352 - Potassium-titanyl Phosphate (KTP) Laser vs KTP Laser and Ivermectin Cream for Facial Rosacea Phase 2
Completed NCT03263273 - Study to Evaluate the Safety and Efficacy of Topical Minocycline Gel in Patients With Papulopustular Rosacea Phase 2
Completed NCT04508660 - CGB-400 for the Reduction of Facial Redness Phase 1
Completed NCT04508205 - CGB-400 for the Reduction of Facial Redness and Bumps and Blemishes Phase 1
Completed NCT05094700 - A Study of a Polymeric Surfactant Technology Cleanser in Sensitive Skin Participants N/A
Active, not recruiting NCT03211585 - EVALUATION OF THE EFFECT OF THE PERFECTA V-BEAM LASER ON ROSACEA N/A
Completed NCT02576847 - Study to Evaluate the Long-term Safety of a Once-Daily Omiganan Topical Gel Phase 3
Completed NCT02576860 - Study to Evaluate the Safety and Efficacy of a Once-Daily CLS001 Topical Gel Versus Vehicle Phase 3
Completed NCT02637232 - Mirvaso® Utilisation and Patient Satisfaction Evaluation (MUSE)
Completed NCT02583009 - A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Rosacea Phase 2
Completed NCT01993446 - A Safety and Efficacy Study of DRM02 in Subjects With Rosacea Phase 2