NCT00645164

Brief Summary

The product is being tested to see if exposure to light causes photoallergic reactions on the skin.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Mar 2008

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

March 1, 2008

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

March 24, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 27, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
10 months until next milestone

Results Posted

Study results publicly available

April 6, 2009

Completed
Last Updated

June 8, 2010

Status Verified

June 1, 2010

Enrollment Period

2 months

First QC Date

March 24, 2008

Results QC Date

October 8, 2008

Last Update Submit

June 1, 2010

Conditions

Healthy

Keywords

wound healingphotoallergenicityHealthy subjects

Outcome Measures

Primary Outcomes (1)

  • Frequency Distribution of Skin Irritation Scores

    Scores based on skin irritation scale of 0 (no reaction) to 7 (large vesiculo-bullous reaction) in whole units. Photoallergic reactions were characterized by irritation scores of 3 or higher.

    48-hours post irradiation

Study Arms (1)

Xenaderm

EXPERIMENTAL

Subject serves as own control

Other: Ointment VehicleDrug: Xenaderm

Interventions

Ointment VehicleOTHER

Subject acts as own control. 20 mg under Finn chambers

Xenaderm
XenadermDRUG

20 mg under Finn chambers

Xenaderm

Eligibility Criteria

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

You may qualify if:

  • Healthy subjects

You may not qualify if:

  • Less than 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Suncare Research Laboratories

Winston-Salem, North Carolina, United States

Location

MeSH Terms

Interventions

OintmentsGranulex

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical Preparations

Limitations and Caveats

Interpretation of frequency distribution of skin irritation scores was based on long term experience with this type of testing.

Results Point of Contact

Title
Herbert B. Slade MD, FAAAAI
Organization
DFB Pharmaceuticals
bert.slade@dfbpharmaceuticals.com
817.302.3919

Study Officials

  • Joe Stanfield, PhD

    Suncare Research Laboratories

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 24, 2008

First Posted

March 27, 2008

Study Start

March 1, 2008

Primary Completion

May 1, 2008

Study Completion

June 1, 2008

Last Updated

June 8, 2010

Results First Posted

April 6, 2009

Record last verified: 2010-06

Locations

US(1)