NCT00603772

Brief Summary

To assess the potential of tretinoin gel 0.05% and its vehicle to produce photoallergic reactions, measured as skin reactions following induction and challenge.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2008

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 29, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

May 6, 2008

Status Verified

February 1, 2008

Enrollment Period

2 months

First QC Date

January 8, 2008

Last Update Submit

May 5, 2008

Conditions

Healthy

Keywords

Tretinoinexposure to UV lightphototoxicitySafety when exposed to sunlight

Outcome Measures

Primary Outcomes (1)

  • UV Induced skin irritation

    4 days

Study Arms (1)

1

EXPERIMENTAL

Safety when exposed to sunlight

Drug: Atralin (tretinoin) gel, 0.05%

Interventions

Atralin (tretinoin) gel, 0.05%DRUG

Assess photoallergic reactions for tretinoin 0.05% and vehicle, measured as skin reactions following induction and challenge.

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 and 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

Conditions

Dermatitis, Phototoxic

Interventions

TretinoinGels

Condition Hierarchy (Ancestors)

Dermatitis, IrritantDermatitis, ContactDermatitisSkin DiseasesSkin and Connective Tissue DiseasesPhotosensitivity DisordersSkin Diseases, Eczematous

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Joseph W Stanfield, MS

    Suncare Research 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 8, 2008

First Posted

January 29, 2008

Study Start

January 1, 2008

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

May 6, 2008

Record last verified: 2008-02

Locations

US(1)