Safety and Efficacy Study to Compare Two Rosacea Treatmen... | NCT00495313

Studies
Safety and Efficacy Study to Compare Two Rosacea Treatment Regimens

NCT00495313

Sponsor

CollaGenex Pharmaceuticals

Status

Completed

Last Update Posted

Dec 16, 2008Estimated

Enrollment

91Actual

Phase

Phase 4

Conditions

Rosacea

Interventions

doxycycline
doxycycline

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

Dec 2007Actual

Completion Date

Dec 2007Actual

First Submitted Date

Jun 29, 2007

First Submission Date that Met QC Criteria

Jun 29, 2007

First Posted Date

Jul 3, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 11, 2008

Last Update Posted Date

Dec 16, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To compare the safety and efficacy of two treatment regimens: 1) COL-101 and metronidazole gel 1%; 2) Doxycycline hyclate 100 mg and metronidazole gel 1%

Detailed Description

Compare the safety and efficacy of two treatment regimens: 1) COL-101 and metronidazole gel 1%; 2) Doxycycline hyclate 100 mg and metronidazole gel 1%

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

91Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohort 1: doxycycline	Active Comparator	Vibramycin plus metronidazole	Drug: doxycycline
Cohort 2	Active Comparator	Oracea® delayed release plus metronidazole	Drug: doxycycline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
doxycycline	Drug	COL-101, QD plus metronidazole	Cohort 1: doxycycline

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in total lesion count from Baseline at the study endpoint		16 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change in Investigator's Global Assessment from Baseline at the study endpoint		16 weeks
Change in Clinician's Erythema Assessment score from Baseline at the study endpoint		16 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

8-40 total lesions
erythema
telangiectasia

Exclusion Criteria:

non-pregnant, non-lactating
achlorhydric
gastric by-pass surgery
allergy to study medications
drug/alcohol abuse
use of proton pump inhibitors

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christopher V Powala, JD	CollaGenex Pharmaceuticals	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Joel Schlessinger		Omaha	Nebraska	68144	United States
James Del Rosso

Condition Browse Module

MeSH Terms

ID	Term
D012393	Rosacea

Ancestor Terms

ID	Term
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004318	Doxycycline
D008795	Metronidazole

Ancestor Terms

ID	Term
D013754	Tetracyclines
D009279	Naphthacenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic

Browse Leaves

Not provided

Browse Branches

Not provided