NCT00644917

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Feb 2008

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

February 1, 2008

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
2 months 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
5.8 years until next milestone

Results Posted

Study results publicly available

January 13, 2014

Completed
Last Updated

January 13, 2014

Status Verified

December 1, 2013

Enrollment Period

Same day

First QC Date

March 24, 2008

Results QC Date

October 9, 2013

Last Update Submit

December 11, 2013

Conditions

Healthy

Keywords

wound healingphototoxicityHealthy Subjects

Outcome Measures

Primary Outcomes (1)

  • Skin Reaction Score

    Scores for phototoxic skin irritation were used to evaluate safety. In this study, irritation was graded using a scale that ranged from 0 (no reaction) to 7 (large vesiculo-bullous reaction) in whole units.

    48 hours

Study Arms (3)

A

EXPERIMENTAL

Drug

Drug: Xenaderm

B

PLACEBO COMPARATOR

Placebo comparator

Drug: Placebo

C

NO INTERVENTION

Subjects serve as own controls.

Interventions

XenadermDRUG

20mg under Finn chambers

A
PlaceboDRUG

20mg under Finn chambers

B

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:

  • Under 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dermatitis, Phototoxic

Interventions

Granulex

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Jaime E Dickerson, Jr, PhD
Organization
Smith & Nephew Biotherapeutics
jaime.dickerson@smith-nephew.com
817-302-3914

Study Officials

  • Innes Cargill, PhD

    Healthpoint, Ltd.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
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

February 1, 2008

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

January 13, 2014

Results First Posted

January 13, 2014

Record last verified: 2013-12