NCT00604032

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Jan 2008

Shorter than P25 for phase_1 healthy

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

January 1, 2008

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 29, 2008

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

March 28, 2008

Status Verified

February 1, 2008

Enrollment Period

Same day

First QC Date

January 16, 2008

Last Update Submit

March 26, 2008

Conditions

Healthy

Keywords

Safety when exposed to sunlight

Outcome Measures

Primary Outcomes (1)

  • UV induced skin sensitization

    4 days

Study Arms (1)

1

PLACEBO COMPARATOR
Drug: Atralin (tretinoin) Gel, 0.05%

Interventions

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

Eligibility Criteria

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

You may qualify if:

  • Normal healthy volunteers
  • years of age or older

You may not qualify if:

  • Less than 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Suncare Research Laboratories

Winston-Salem, North Carolina, 27106, United States

Location

MeSH Terms

Interventions

TretinoinGels

Intervention Hierarchy (Ancestors)

Vitamin ARetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesDiterpenesPigments, BiologicalBiological FactorsColloidsComplex MixturesDosage FormsPharmaceutical Preparations

Study Officials

  • Joseph Stanfiled, MS

    Suncare Laboratories

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 16, 2008

First Posted

January 29, 2008

Study Start

January 1, 2008

Primary Completion

January 1, 2008

Study Completion

February 1, 2008

Last Updated

March 28, 2008

Record last verified: 2008-02

Locations

US(1)