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ORCA - Oracea® for Rosacea: A Community-based Assessment

Information source: Galderma Laboratories, L.P.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rosacea

Intervention: doxycycline (Oracea®) 40 mg modified release as monotherapy (Drug); doxycycline (Oracea®) 40 mg modified release as add-on therapy (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Galderma Laboratories, L.P.

Official(s) and/or principal investigator(s):
Ronald W Gottschalk, MD, Study Director, Affiliation: Galderma Laboratories, L.P.

Summary

The objective of this study is to assess the effectiveness, safety, subject satisfaction and quality of life with Oracea when used as monotherapy or as add-on therapy to existing topical regimens for the treatment of rosacea.

Clinical Details

Official title: A Phase 4, Open-Label, Multicenter, Community-based, 12-Week Trial Assessment of Effectiveness, Safety, and Subject Satisfaction With Oracea [Doxycycline, USP] Capsules 40 mg (30 mg Immediate Release & 10 mg Delayed Release Beads) When Used as Monotherapy or as Add-On Therapy to Existing Topical Regimens for the Treatment of Rosacea

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change in Investigator's Global Assessment (IGA) Score From Baseline to Endpoint

Secondary outcome:

Change in Clinician's Erythema Assessment Scale (CEA) Score From Baseline to Endpoint

Number of Treatment Responders at Endpoint, Where Response is Defined as an IGA Score of 0 (Clear) or 1 (Near Clear)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Males and females aged 18 and older

- Subjects with diagnosis of rosacea (IGA of 2 to 4)

Exclusion Criteria:

- Subjects who used a topical or systemic acne treatment within 4 months of the

baseline visit (retinoids and isotretinoin)

- Subjects who used a topical or systemic antibiotic within 4 weeks of the baseline

visit

- Subjects who had laser or IPL (intense pulsed light) treatments within 3 months of

the baseline visit and/or who plan to have these treatments during the study

- Subjects who have a known hypersensitivity to tetracyclines or ingredients of the add

on medications

- Subjects who have stomach or GI problems, kidney disease or have an active systemic

fungal infection or a vaginal yeast infection are excluded

Locations and Contacts

REGISTRAT® - MAP1, Inc. (CRO), Lexington, Kentucky 40504-3276, United States
Additional Information

Starting date: April 2009
Last updated: September 21, 2012

Page last updated: August 23, 2015

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