NCT00850681

Brief Summary

This Phase 1 study is designed to determine the photoallergic potential of PEP005 Gel, 0.01% and it's vehicle on normal skin.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2009

Shorter than P25 for phase_1

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

February 1, 2009

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

February 23, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 25, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

September 9, 2015

Status Verified

April 1, 2009

Enrollment Period

2 months

First QC Date

February 23, 2009

Last Update Submit

September 7, 2015

Conditions

Actinic Keratosis

Keywords

PeplinPEP005

Outcome Measures

Primary Outcomes (1)

  • To determine the photoallergic (sensitizing) potential of PEP005 Gel and it's vehicle on normal skin.

    6 weeks

Study Arms (1)

1

EXPERIMENTAL

PEP005 (ingenol mebutate) Gel

Drug: PEP005 (ingenol mebutate) Gel

Interventions

PEP005 (ingenol mebutate) GelDRUG

PEP005 (ingenol mebutate) Gel, 0.01%

1

Eligibility Criteria

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

You may qualify if:

  • are healthy males or females;
  • in the case of females of childbearing potential, are using an acceptable form of birth control and provide a negative urine pregnancy test;
  • read, understand and provide signed informed consent.

You may not qualify if:

  • are not willing to refrain from using topical/systemic analgesics within 72 hours prior to and during the study;
  • are using systemic/locally-acting medications during the study and within 2 weeks prior to the beginning of the study;
  • are using systemic/locally-acting anti-inflammatories during the study and within 72 hours prior to the beginning of the study;
  • have participated in any clinical testing of an investigational drug within 28 days or any clinical patch application within 14 days prior to enrollment or are currently participating in any clinical testing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TKL Research, Inc.

Paramus, New Jersey, 07652, United States

Location

Related Publications (1)

  • Dosik JS, Damstra M, Udell C, Welburn P. Evaluation of the skin sensitization, photoirritation, and photoallergic potential of ingenol mebutate gel in healthy volunteers. J Clin Aesthet Dermatol. 2014 Apr;7(4):35-42.

    PMID: 24765228DERIVED

Related Links

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

3-ingenyl angelateGels

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsKeratosisSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

ColloidsComplex MixturesDosage FormsPharmaceutical Preparations

Study Officials

  • Jonothan S Dosik, MD

    TKL Research, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 23, 2009

First Posted

February 25, 2009

Study Start

February 1, 2009

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

September 9, 2015

Record last verified: 2009-04

Locations

US(1)