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A Phase 2 Multi-centre, Parallel Group, Open Label Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, 0.05%, When Administered for up to Three Consecutive Days to a Superficial Basal Cell Carcinoma (sBCC) on the Trunk or Extremities


Phase 2
18 Years
N/A
Not Enrolling
Both
Superficial Basal Cell Carcinoma

Thank you

Trial Information

A Phase 2 Multi-centre, Parallel Group, Open Label Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, 0.05%, When Administered for up to Three Consecutive Days to a Superficial Basal Cell Carcinoma (sBCC) on the Trunk or Extremities


Inclusion Criteria:



- Must be male or female and at least 18 years of age

- Female patients must be of: non-childbearing potential or if of childbearing
potential then have a negative serum and urine pregnancy test and using effective
contraception

- Ability to provide informed consent

- primary diagnosed and histologically confirmed sBCC located on the trunk or
extremities which is suitable for excision

Exclusion Criteria:

- location of the sBCC lesion within 10cm of an incompletely healed wound, on the hand
or foot, on the breast of women, on the anogenital area.

- Undergone cosmetic or therapeutic procedures within 2cm of the selected treatment
area in the 2 weeks prior to the screening visit.

- Use of acid-containing therapeutic products within 2 cm of the selected treatment
area in the 2 weeks prior to the screening visit

- Use of topical moisturisers/creams/lotions (non-medicated/non-irritant salves are
acceptable), artificial tanners or topical steroids: within 2 cm of the selected
treatment area.

- Have received treatment with immunomodulators, or interferon/interferon inducers,
systematic medications that suppress the immune system or UVB in the last 4 weeks

- Have undergone treatment with 5-FU, imiquimod, diclofenac or photodynamic therapy
within 2 cm of the selected treatment area within 8 weeks prior to any screening
visit.

- Use of systemic retinoids.

- Those who are currently participating in any other clinical trial

- Those known or suspected of not being able to comply with the requirements of the
protocol

- Females who are pregnant or are breastfeeding

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Treatment related Adverse Events, Local Skin Responses; Pigmentation and scarring

Outcome Description:

Number of participants with treatment related Adverse Events, change from baseline in LSR and pigmentation and scarring.

Outcome Time Frame:

120 days

Safety Issue:

Yes

Principal Investigator

Jacqueline Morley

Investigator Role:

Study Director

Investigator Affiliation:

Peplin Operations

Authority:

Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:

PEP005-037

NCT ID:

NCT01325688

Start Date:

April 2011

Completion Date:

March 2012

Related Keywords:

  • Superficial Basal Cell Carcinoma
  • PEP005
  • Peplin
  • sBCC
  • Carcinoma
  • Carcinoma, Basal Cell

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