Clinical trials
For information regarding Peplin's PEP005 (ingenol mebutate) Gel clinical trial programme or to find a participating centre. Please refer to: www.clinicaltrials.gov and type "peplin" in the search box. Alternatively, key clinical trials are summarized below.
Current studies
| Reference | Development Phase | Status | Indication | No. of Patients | Additional information |
|---|---|---|---|---|---|
| PEP005-009 | Phase 2a | Ongoing | sBCC | 58 (est) | See press release |
Completed studies
| Reference | Development Phase | Status | Indication | No. of Patients | Additional information |
|---|---|---|---|---|---|
| REGION-Ib | Phase 3 | Completed January 2010 | AK, Non-Head | 200 | See press release |
| REGION-IIa | Phase 3 | Completed December 2009 | AK, Head | 250 | See press release |
| REGION-IIb | Phase 3 | Completed December 2009 | AK, Head | 250 | See press release |
| REGION-I | Phase 3 | Completed May 2009 | AK, Non-Head | 250 | See press release |
| PEP005-015 | Phase 2b | Completed March 2009 | AK, Head | 240 | See press release |
| PEP005-007 | Phase 2 | Completed December 2007 | AK, face or face and scalp | 88 | See press release |
| PEP005-006 | Phase 2 | Completed June 2007 | AK, body and scalp | 222 | See press release |
| PEP005-022 | Phase 2b | Completed late 2008 | AK extensor forearm | 64 | Open label safety study |
| PEP005-008 | Phase 2 | Completed March 2007 | Cutaneous squamous cell carcinoma | 25 | See press release |
| PEP005-002 | Phase 2a | Completed July 2006 | Safety in nodular basal cell carcinoma | 58 | See press release |
| PEP005-003 | Phase 2a | Completed April 2006 | Safety in superficial basal cell carcinoma | 60 | See press release |
| PEP005-004 | Phase 2a | Completed February 2006 | Safety in AK | 22 | See press release |
| PEP005-001 | Phase 2a | Completed November 2005 | Safety in AK | 63 | See press release |
| PEP005-005 | Phase 1 | Completed October 2006 | Safety study: sensitisating potential of PE0005 in healthy volunteers | 238 | There were no reactions greater than minimal erythema at any time during induction |
For further information please contact us at info@peplin.com
