NCT00892281

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,421

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

April 30, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 4, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

November 18, 2010

Completed
Last Updated

August 25, 2022

Status Verified

September 1, 2012

Enrollment Period

6 months

First QC Date

April 30, 2009

Results QC Date

October 26, 2010

Last Update Submit

July 28, 2022

Conditions

Rosacea

Outcome Measures

Primary Outcomes (1)

  • Change in Investigator's Global Assessment (IGA) Score From Baseline to Endpoint

    Number of participants with a change (Week 12 minus Baseline) in Investigator's Global Assessment (IGA) score. IGA is measured on a scale from 0 - 4 with 0 = Clear; 1 = Near Clear; 2 = Mild; 3 = Moderate; and 4 = Severe. Results values (+4, +3, +2, +1, 0, -1, -2, -3, -4) represent change from Baseline to Week 12.

    Baseline to Week 12

Secondary Outcomes (2)

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

    Baaseline to Week 12

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

    Baseline to Week 12

Study Arms (2)

Oracea® as monotherapy

OTHER

Oracea as monotherapy

Drug: doxycycline (Oracea®) 40 mg modified release as monotherapy

Oracea® as add-on therapy

OTHER

Oracea® as add-on Therapy (Oracea® + Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides

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

Interventions

doxycycline (Oracea®) 40 mg modified release as monotherapyDRUG

Take once daily in the morning

Also known as: Oracea®
Oracea® as monotherapy
doxycycline (Oracea®) 40 mg modified release as add-on therapyDRUG

Take once daily in the morning

Also known as: Oracea®
Oracea® as add-on therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females aged 18 and older
  • Subjects with diagnosis of rosacea (IGA of 2 to 4)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

REGISTRAT® - MAP1, Inc. (CRO)

Lexington, Kentucky, 40504-3276, United States

Location

MeSH Terms

Conditions

Rosacea

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Results Point of Contact

Title
Ronald W. Gottschalk, MD / Medical Director
Organization
Galderma Laboratories, L.P.
ron.gottschalk@galderma.com
817-961-5358

Study Officials

  • Ronald W Gottschalk, MD

    Galderma R&D

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2009

First Posted

May 4, 2009

Study Start

April 1, 2009

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

August 25, 2022

Results First Posted

November 18, 2010

Record last verified: 2012-09

Locations

US(1)