Study to Determine the Phototoxity of Atralin (Tretinoin)... | NCT00604032

Studies
Study to Determine the Phototoxity of Atralin (Tretinoin) Gel, 0.05%

NCT00604032

Sponsor

Coria Laboratories, Ltd.

Status

Completed

Last Update Posted

Mar 28, 2008Estimated

Enrollment

60Actual

Phase

Phase 1

Conditions

Healthy

Interventions

Atralin (tretinoin) Gel, 0.05%

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

Feb 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

Jan 2008

Primary Completion Date

Jan 2008Actual

Completion Date

Feb 2008Actual

First Submitted Date

Jan 16, 2008

First Submission Date that Met QC Criteria

Jan 28, 2008

First Posted Date

Jan 29, 2008Estimated

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

Mar 26, 2008

Last Update Posted Date

Mar 28, 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 assess the potential of tretnoin gel 0.05% to produce phototoxic reactions, measured as skin reactions 24 and 48 hours after UV radiation of drug on skin.

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Placebo Comparator		Drug: Atralin (tretinoin) Gel, 0.05%

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Atralin (tretinoin) Gel, 0.05%	Drug	Assess potential of tretinoin gel, 0.05% to produce phototoxic reactions, measured 24 and 48 hours after UV radiation of drug on the skin.	1

Measure	Description	Time Frame
UV induced skin sensitization		4 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Normal healthy volunteers
18 years of age or older

Exclusion Criteria:

Less than 18 years of age

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
Joseph Stanfiled, MS	Suncare Laboratories	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Suncare Research Laboratories		Winston-Salem	North Carolina	27106	United States

Intervention Browse Module

MeSH Terms

ID	Term
D014212	Tretinoin
D005782	Gels

Ancestor Terms

ID	Term
D014801	Vitamin A
D012176	Retinoids
D002338	Carotenoids
D011090	Polyenes
D000475

Browse Leaves

Not provided

Browse Branches

Not provided