Phase 2 N=265 Randomized Triple-blind Treatment

A Multicenter Study to Evaluate the Safety and Efficacy of PEP005 Topical Gel When Used to Treat Actinic Keratoses on the Head (Face or Scalp)

Actinic Keratosis

Bottom Line

View on ClinicalTrials.gov: NCT00700063 ↗

Enrolled (actual)

265

Serious AEs

0.8%

Results posted

Aug 2012

Primary outcome: Primary: Incidence of AEs Recorded Throughout the Study — 12; 12; 8; 11 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: PEP005 Topical Gel (Drug); Vehicle gel (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Peplin
Primary completion: Oct 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Incidence of AEs Recorded Throughout the Study	12; 12; 8; 11; 11; 14	—
PRIMARY Incidence of SAE Recorded Throughout the Study	0; 0; 0; 0; 1; 0	—
PRIMARY Incidence Rate and Severity of LSRs Following Study Medication Application	0.8; 1.1; 0.8; 1.3; 1.4; 1.1	—
PRIMARY Incidence Rate and Severity of LSRs Following Study Medication Application	0.8; 1.1; 0.8; 1.3; 1.4; 1.1	—
PRIMARY Incidence of Hyperpigmentation Following Study Medication Application	13; 13; 7; 6; 8; 11	—
PRIMARY Incidence of Hyperpigmentation Following Study Medication Application	13; 13; 7; 6; 8; 11	—
PRIMARY Incidence of Hypopigmentation Following Study Medication Application	4; 6; 6; 6; 9; 9	—
PRIMARY Incidence of Hypopigmentation Following Study Medication Application	4; 6; 6; 6; 9; 9	—
PRIMARY Incidence of Scarring Following Study Medication Application	1; 1; 1; 1; 5; 1	—
PRIMARY Incidence of Scarring Following Study Medication Application	1; 1; 1; 1; 5; 1	—
PRIMARY Complete Clearance Rate of AK Lesions;	5; 10; 12; 0; 11; 6	—
SECONDARY Efficacy (Clearance of AK Lesions) Partial Clearance Rate	11; 17; 17; 3; 14; 9	—

Summary

This Phase IIb study is designed to assess the safety and efficacy of 0.005%, 0.01% and 0.015% PEP005 Topical Gel when applied to an area of skin, containing 4-8 AK lesions on the face or scalp.

Eligibility Criteria

Inclusion Criteria

Must be male or female
Female patients must be of
Non-childbearing potential;
Childbearing potential, provided negative pregnancy test and using effective contraception
4 to 8 AK lesions on the face or scalp

Exclusion Criteria

Cosmetic or therapeutic procedures within 2 weeks and within 2 cm of the selected treatment area.
Treatment with immunomodulators, or interferon/ interferon inducers or systemic medications that suppress the immune system: within 4 weeks.
Treatment with 5-FU, imiquimod, diclofenac, or photodynamic therapy:

within 8 weeks and 2 cm of treatment area

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00700063). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.