Evaluation of Rosacea-related Inflammatory Biochemical Markers in Adult Skin When Treated With Oracea® vs Placebo
Recruiting in Palo Alto (17 mi)
+9 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Waitlist Available
Sponsor: Galderma Laboratories, L.P.
No Placebo Group
Prior Safety Data
Approved in 5 Jurisdictions
Trial Summary
What is the purpose of this trial?
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.
Research Team
RW
Ronald W Gottschalk, MD
Principal Investigator
Galderma R&D
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)
Treatment Details
Interventions
- Doxycycline (Tetracycline Antibiotic)
- Placebo (Other)
Participant Groups
2Treatment groups
Active Control
Group I: Oracea®Active Control1 Intervention
Doxycycline 40 mg (30 mg immediate release / 10 mg delayed release beads) Capsules
Group II: placeboActive Control1 Intervention
placebo
Doxycycline is already approved in Canada, Japan for the following indications:
Approved in Canada as Doxycycline for:
- Acne
- Bacterial infections
- Chlamydia
- Gonorrhea
- Lyme disease
- Malaria
- Pneumonia
- Rosacea
- Urinary tract infections
Approved in Japan as Doxycycline for:
- Acne
- Bacterial infections
- Chlamydia
- Gonorrhea
- Lyme disease
- Malaria
- Pneumonia
- Rosacea
- Urinary tract infections
Find a Clinic Near You
Who Is Running the Clinical Trial?
Galderma Laboratories, L.P.
Lead Sponsor
Trials
49
Recruited
9,200+
Galderma R&D
Lead Sponsor
Trials
303
Recruited
60,700+
Flemming Ørnskov
Galderma R&D
Chief Executive Officer since 2019
MD, MPH
Baldo Scassellati Sforzolini
Galderma R&D
Chief Medical Officer
MD, PhD