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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00375739
Other study ID # PEP005-006
Secondary ID
Status Completed
Phase Phase 2
First received September 11, 2006
Last updated January 26, 2016
Start date September 2006
Est. completion date June 2007

Study information

Verified date January 2016
Source Peplin
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether topical application of PEP005 is safe for the treatment of actinic keratoses.


Description:

Actinic keratoses (AK) is a common skin condition characterized by rough, scaly patches or sores on the top layer of the skin which if left untreated can progress to skin cancer. Current treatments can cause scarring and hypopigmentation, be inconvenient, or require long treatment duration. Non-invasive alternative therapy for treatment of AK lesions is thus being researched.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date June 2007
Est. primary completion date June 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion

1. Male patients at least 18 years of age.

2. Post-menopausal female patients i.e., no menses for at least 12 consecutive months, or without a uterus.

3. 4 to 8 clinically typical, visible and discrete AK lesions within a contiguous 25 cm2 treatment area on the arm, shoulder, chest, back or scalp.

4. Screening laboratory values within the reference ranges as defined by the central laboratory or "out of range" test results that are clinically acceptable to the Investigator.

5. Ability to follow study instructions and likely to complete all study requirements.

6. Written informed consent has been obtained.

7. Written Authorization for Use and Release of Health and Research Study Information has been obtained.

8. Agreement from the patient to allow photographs of the selected AK treatment area to be taken and used as part of the study data package.

Exclusion

1. Females of child bearing potential (a female is considered of childbearing potential unless she is postmenopausal, i.e., no menses for at least 12 consecutive months, or is without a uterus).

2. Location of the selected AK treatment area:

1. anywhere on the face

2. within 5 cm of an incompletely healed wound

3. on the breast area of women

4. on the dorsum of the hand

3. AK lesions that have atypical clinical appearance e.g. hypertrophic, hyperkeratotic, recalcitrant disease (had cryosurgery on 2 previous occasions), cutaneous horns within the selected AK treatment area.

4. Presence of suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) within the selected AK treatment area or within 10 cm of the selected AK treatment area.

5. Presence of known or suspected metastatic disease.

6. History or evidence of skin conditions other than AK that would interfere with evaluation of the study drug (e.g. eczema, unstable psoriasis, xeroderma pigmentosa).

7. Known sensitivity to any of the ingredients in the study drug.

8. A cosmetic or therapeutic procedure (e.g. use of liquid nitrogen, surgical excision, curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing):

- within 2 cm of the selected AK treatment area during the 4 weeks prior to screening visit

9. Treatment with 5-fluorouracil, imiquimod, diclofenac, masoprocol or photodynamic therapy:

- within 2 cm of the selected AK treatment area during the 24 months prior to screening visit or

- anywhere during the 4 weeks prior to screening visit

10. Treatment with other immunomodulators (e.g. vinblastine, podophyllin, colhamin, camptothecin), cytotoxic drugs (e.g. cyclophosphamide, azathiopine, chlorambucil, nitrogen mustard, methotrexate), or interferon/ interferon inducers:

- within 4 weeks prior to screening visit

11. Use of acid-containing therapeutic products (e.g. salicylic acids or fruit acids, such as alpha and beta hydroxy acids and glycolic acids), topical retinoids or light chemical peels:

- within 2 cm of the selected AK treatment area during the 4 weeks prior to screening visit

12. Treatment with psoralen plus UVA (PUVA) or use of UVB therapy:

- anywhere during the 6 months prior to screening visit

13. Use of systemic retinoids (e.g. isotretinoin, acitretin, bexarotene):

- within 6 months prior to screening visit

14. Anticipated excessive or prolonged exposure to ultraviolet light (e.g. sunlight, tanning beds).

15. Use of topical salves, artificial tanners or topical steroids:

- On the selected AK treatment area during the 4 weeks prior to screening visit

16. Anticipated need for hospitalization (in-patient) or surgery (except that specified in exclusion criteria 8) during the study.

17. Concurrent disease that suppresses the immune system (e.g. HIV, hepatitis).

18. Uncontrolled systemic disease (e.g. uncontrolled hypertension [a systolic blood pressure of 180 mmHg or greater and/or a diastolic blood pressure of 110 mmHg or greater], poorly controlled diabetes [fasting blood sugar of 350 mg/dl or greater]).

19. Use of systemic medications that suppress the immune system (e.g. cyclosporine, prednisone, methotrexate, alefacept, infliximab):

- within 4 weeks prior to screening visit

20. Current evidence of chronic alcohol or drug abuse.

21. Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study or entry into another investigational drug or device study while enrolled in this study.

22. A condition or situation which in the Investigator's opinion may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study [e.g. patients who required hospitalization in the 2 months prior to screening for an acute or chronic condition].

23. Selected AK treatment area within 5 cm of an AK lesion previously treated with PEP005, for those patients who have participated in earlier PEP005 topical gel trials. Patients enrolled in Treatment Phase 1 can not be re-enrolled into Treatment Phase 2.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
PEP005


Locations

Country Name City State
United States Academic Dermatology Associates Albuquerque New Mexico
United States Radiant Research Anderson South Carolina
United States Oregon Medical Research Centre9495 SW Locust St., Suite G Portland Oregon
United States University Dermatology Consultants, Inc., Dermatology Clinical Research Center Cincinnati Ohio
United States Advanced Dermatology and Cosmetic Surgery Clermont Florida
United States Radiant Research Columbus Ohio
United States Dermatology Associates and Research Coral Gales Florida
United States Radiant Research Greer South Carolina
United States Burke Pharmaceutical Research Hot Springs Arkansas
United States Medical Affiliated Research Center, Inc. Huntsville Alabama
United States North Florida Dermatology Associates P.A. Jacksonville Florida
United States Mount Sinai Hospital School of Medicine New York New York
United States St. Luke's/Roosevelt Hospital Center Dermatology New York New York
United States Medaphase, Inc Newnan Georgia
United States Park Avenue Dermatology, PA Orange Park Florida
United States Dermatology Research Centre Salt Lake City Utah
United States Dermatology Clinical Research Center of San Antonio San Antonio Texas
United States Gwinnett Clinical Research Centre, Inc Snellville Georgia
United States Skokane Dermatology Clinic, PLLP. Spokane Washington
United States Dermatology Associates of Tallahassee Tallahassee Florida
United States Radiant Research Tucson Arizona
United States Dermatology Associates of Tyler Tyler Texas
United States Henry Ford Health Center- Farmington Road West Bloomfield Michigan
United States Palm Beach Aesthetics West Palm Beach Florida

Sponsors (1)

Lead Sponsor Collaborator
Peplin

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety
Secondary Resolution of AK
See also
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Completed NCT01686152 - Study Comparing Imiquimod Cream, 3.75% to Zyclara® (Imiquimod) Cream, 3.75% in the Treatment of Actinic Keratosis Phase 3
Completed NCT01444989 - Development and Validation of a Quality of Life Instrument for Actinic Keratosis N/A
Completed NCT01449513 - PEP005 Gel - Biological Effects in Actinic Keratosis Assessed by Reflectance Confocal Microscopy Phase 1
Terminated NCT01525329 - Combination Therapy With 5-Fluorouracil and Photodynamic Therapy in Post-transplant Premalignant Skin Disease Phase 3
Terminated NCT01203878 - Treatment of Actinic Keratoses of the Face With Imiquimod 3.75% Cream Followed by Photodynamic Therapy Phase 4
Completed NCT00989313 - A Long Term Follow up Study of Patients Who Have Complete Clearance of Their Actinic Keratosis (AK) Lesions at the Day 57 Visit in the PEP005-028 Study Phase 3
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Completed NCT02866695 - Safety and Efficacy of Ingenol Mebutate Gel 0.015% for Treatment of AK on the Face in Solid Organ Transplant Recipients Phase 4
Completed NCT02952898 - Study Comparing GDC 695 and Diclofenac Sodium Gel, 3% in Subjects With Actinic Keratoses Phase 3
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Recruiting NCT03684772 - Topical Ionic Contra-Viral Therapy in Actinic Keratosis Phase 2
Completed NCT02878382 - Potential Impact of Patient Vitamin D Status in AK Response to MAL-PDT N/A
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Completed NCT02938715 - Pilot Study of the Pragmatic Use of Mobile Phone Based Follow up of Actinic Keratoses Treated With Topical 5-fluorouracil N/A