⭐️⭐️⭐️⭐️⭐️ "A total no brainer"

⭐️⭐️⭐️⭐️⭐️ "Love this, so easy."

Spots is the easy way to track your skin, mole and cancer changes.

Spots Global Cancer Trial Database for Study to Determine the Safety of Two Applications of PEP005 Topical Gel to Nodular Basal Cell Carcinoma

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Study to Determine the Safety of Two Applications of PEP005 Topical Gel to Nodular Basal Cell Carcinoma

Official Title: A Multi-center, Randomized, Double-blind, Parallel-group, Vehicle-controlled Study to Determine the Safety of PEP005 0.0025%, 0.01% and 0.05% Gel With Two Treatment Schedules, Day 1 & 2 or Day 1 & 8 Applications to Nodular Basal Cell Carcinoma

Study ID: NCT00108121

Interventions

PEP005

Study Description

Brief Summary: The purpose of this study is to determine whether topical application of PEP005 is safe for the treatment of nodular basal cell carcinoma.

Detailed Description: Basal cell carcinomas (BCCs) are a common skin problem largely caused by long term sun exposure. Current treatments include surgery, curettage/desiccation and simple excision, which are often cosmetically disfiguring. Non-invasive alternative therapy for treatment of BCC lesions is thus being researched. Sap from the plant Euphorbia peplus has been used for many years in Australia as a "folk" remedy to treat a number of skin conditions. The active component of Euphorbia peplus has been isolated and made into a gel applied directly to the skin by Peplin Ltd. To date, only one well-controlled study with PEP005 gel in humans has been completed. Sixteen patients received a single application of PEP005 0.01% or vehicle gel to actinic keratoses on the chest, shoulders, back and/or arms. Results show good tolerance and evidence of activity. The current study is designed to evaluate the safety of two applications of PEP005 gel in patients with nBCC (nodular basal cell carcinoma) on the arms, shoulders, chest, face and/or scalp, testing three concentrations according to two treatment regimens. Approximately 60 patients are planned to be included from multiple Australian centers. Efficacy and cosmetic outcome will be assessed and a recommended treatment regimen will be determined. Assignment to treatment is random and patients and medical staff will be blinded as to the treatment. Patients will have two visits for treatment application and will return for check-up visits the day after the first application and several times thereafter for approximately 3 months.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Southderm Pty Ltd, Sydney, New South Wales, Australia

St George Dermatology & Skin Cancer Centre, Sydney, New South Wales, Australia

Siller Medical, Brisbane, Queensland, Australia

South East Dermatology, Brisbane, Queensland, Australia

The Skin Centre, Gold Coast, Queensland, Australia

13 Eleanor St, Footscray, Victoria, Australia

Skin and Cancer Foundation, Melbourne, Victoria, Australia

Monash Medical Centre, Melbourne, Victoria, Australia

Fremantle Dermatology, Fremantle, Western Australia, Australia

St John of God Dermatology, Subiaco, Western Australia, Australia

Contact Details

Name: Greg Siller

Affiliation:

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

Logo

Take Control of Your Skin and Body Changes Today.

Try out Spots for free, set up only takes 2 mins.

spots app storespots app store

Join others from around the world: