A Clinical Trial to Determine the Effects of 40 Mg Doxycy... | NCT00126399

Studies
A Clinical Trial to Determine the Effects of 40 Mg Doxycycline Versus a Placebo Control for the Treatment of Rosacea

NCT00126399

Sponsor

CollaGenex Pharmaceuticals

Status

Completed

Last Update Posted

Aug 19, 2005Estimated

Enrollment

528

Phase

Phase 3

Conditions

Rosacea

Interventions

doxycycline

Countries

Not provided

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

Aug 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Jun 2004

Primary Completion Date

Not provided

Completion Date

Apr 2005

First Submitted Date

Aug 2, 2005

First Submission Date that Met QC Criteria

Aug 2, 2005

First Posted Date

Aug 4, 2005Estimated

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

Aug 18, 2005

Last Update Posted Date

Aug 19, 2005Estimated

Description Module

Brief Summary

The objective of this study is to evaluate the safety and efficacy of 40 mg doxycycline controlled-release capsules administered once daily for the treatment of rosacea compared with a placebo.

Detailed Description

Not provided

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

528

Name	Type	Description	Arm Group Labels	Other Names
doxycycline	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in total inflammatory lesion count

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline in erythema scale scores
change from baseline in the investigator's global assessment (IGA) score
proportion of patients being clear or near-clear at endpoint

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Main Inclusion Criteria:

Healthy patients with rosacea
Males and females ≥18 years of age
10 to 40 papules and pustules and ≤2 nodules
Score of 2 to 4 on the IGA
Presence of telangiectasia
Moderate to severe erythema

Main Exclusion Criteria:

Use of topical acne treatments or topical or systemic antibiotics
Use of systemic retinoids within 90 days of baseline
Use of an investigational drug within 90 days of baseline
Pregnant or nursing women
Women of childbearing potential not using an adequate form of contraception
Change in method of contraception within 4 months of baseline
Known hypersensitivity to tetracyclines
Surgeries that bypass or exclude the duodenum or achlorhydria

Accepts Healthy Volunteers

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

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

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided