Ingenol mebutate
- Generic Name
- Ingenol mebutate
- Drug Type
- Small Molecule
- Chemical Formula
- C25H34O6
- CAS Number
- 75567-37-2
- Unique Ingredient Identifier
- 7686S50JAH
- Background
Ingenol mebutate was approved by the FDA in January 2012, and it is marketed under the name Picato®. Picato gel is indicated for the topical treatment of actinic keratosis. Before approval, ingenol mebutate was called PEP005 as an investigational drug. PEP005 is a selective small molecule activator of protein kinase C (PKC) extracted from the plant Euphorbia peplus, whose sap has been used as a traditional medicine for the treatment of skin conditions including warts and cancer. PEP005 also has potent anti-leukemic effects, inducing apoptosis in myeloid leukemia cell lines and primary AML cells at nanomolar concentrations.
- Indication
For the topical treatment of actinic keratosis.
- Associated Conditions
- Actinic Keratosis (AK)
TreatMent of ActInic KerAtosis Lesions : pharmacoepiDemiological Study of the Impact in Real Life of ingenOl Mebutate Gel (Picato®) on Patients Satisfaction
- Conditions
- Actinic Keratosis
- First Posted Date
- 2019-12-17
- Last Posted Date
- 2023-06-09
- Lead Sponsor
- LEO Pharma
- Target Recruit Count
- 1218
- Registration Number
- NCT04202445
Evaluation of Ingenol Mebutate for Actinic Cheilitis Treatment
- First Posted Date
- 2018-03-02
- Last Posted Date
- 2019-06-19
- Lead Sponsor
- Instituto Nacional de Cancer, Brazil
- Registration Number
- NCT03452566
Efficacy of Ingenol Mebutate on Actinic Keratoses and Field Cancerization vs Cryotherapy
- Conditions
- Actinic Keratosis
- Interventions
- Procedure: cryotherapy
- First Posted Date
- 2016-12-13
- Last Posted Date
- 2019-09-24
- Lead Sponsor
- University of Campania "Luigi Vanvitelli"
- Target Recruit Count
- 50
- Registration Number
- NCT02990221
- Locations
- 🇮🇹
Second University of Naples, Naples, Italy
The Use of Picato® (Ingenol Mebutate) to Treat Actinic Keratosis in Standard Clinical Practice
- First Posted Date
- 2015-11-03
- Last Posted Date
- 2019-01-22
- Lead Sponsor
- LEO Pharma
- Target Recruit Count
- 440
- Registration Number
- NCT02594436
- Locations
- 🇬🇷
Office Based Physician, Athens, Peristeri, Greece
The Real Life Topical Field Treatment of Actinic Keratosis Study
- Conditions
- Actinic Keratosis
- Interventions
- First Posted Date
- 2015-02-12
- Last Posted Date
- 2019-12-13
- Lead Sponsor
- LEO Pharma
- Target Recruit Count
- 1168
- Registration Number
- NCT02362152
- Locations
- 🇳🇱
Lievensberg Ziekenhuis, Bergen op Zoom, Netherlands
Efficacy and Safety of Ingenol Mebutate Gel for Actinic Keratosis Applied on Large Area on Face, Scalp or Chest
- First Posted Date
- 2015-02-11
- Last Posted Date
- 2025-03-10
- Lead Sponsor
- LEO Pharma
- Target Recruit Count
- 729
- Registration Number
- NCT02361216
- Locations
- 🇺🇸
Laser & Skin Surgery Center of Indiana, Carmel, Indiana, United States
IM Versus 5-FU Versus IMI Versus MAL-PDT in Treatment of Actinic Keratosis
- Conditions
- Keratosis, Actinic
- Interventions
- Procedure: methylaminolevulinate photodynamic therapy
- First Posted Date
- 2014-11-02
- Last Posted Date
- 2017-10-30
- Lead Sponsor
- Maastricht University Medical Center
- Target Recruit Count
- 624
- Registration Number
- NCT02281682
- Locations
- 🇳🇱
Maastricht UMC, Maastricht, Limburg, Netherlands
Safety and Efficacy of Ingenol Mebutate 0.05% Gel When Used After Cryotherapy in the Hypertrophic Actinic Keratoses
- Conditions
- Actinic Keratoses
- Interventions
- Procedure: Cryotherapy
- First Posted Date
- 2014-09-29
- Last Posted Date
- 2017-04-26
- Lead Sponsor
- Icahn School of Medicine at Mount Sinai
- Target Recruit Count
- 16
- Registration Number
- NCT02251652
- Locations
- 🇺🇸
Icahn School of Medicine at Mount Sinai, New York, New York, United States
Safety and Tolerability Study of Ingenol Mebutate Compared to 5-FU to Treat Facial Actinic Keratosis
- First Posted Date
- 2014-09-17
- Last Posted Date
- 2014-09-17
- Lead Sponsor
- University of Sao Paulo
- Target Recruit Count
- 100
- Registration Number
- NCT02242747
- Locations
- 🇧🇷
Hospital das Clínicas of the University of São Paulo Medical School (HCFMUSP), Sao Paulo, Brazil
Pharmacokinetics of Ingenol Mebutate Gel in Actinic Keratosis Under Maximum Use Conditions
- First Posted Date
- 2014-04-28
- Last Posted Date
- 2025-02-24
- Lead Sponsor
- LEO Pharma
- Target Recruit Count
- 79
- Registration Number
- NCT02124239
- Locations
- 🇺🇸
Academic Dermatology Associate, Albuquerque, New Mexico, United States
Drug Development Updates
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