Recruitment

Recruitment Status
Completed
Estimated Enrollment
480

Inclusion Criterias

Childbearing potential, provided there is a confirmed negative urine pregnancy test
Non-childbearing potential, or,
Subjects with 5 to 9 clinically typical, visible and discrete AKs within a contiguous 25 cm² treatment area on the face or scalp.
...
Childbearing potential, provided there is a confirmed negative urine pregnancy test
Non-childbearing potential, or,
Subjects with 5 to 9 clinically typical, visible and discrete AKs within a contiguous 25 cm² treatment area on the face or scalp.
Signed Informed Consent Form (ICF) prior to any trial-related procedures
Subject at least 18 years of age
Female subjects of childbearing potential must be willing to use highly effective methods of contraception (Pearl index < 1%)

Exclusion Criterias

History of SCC, BCC, malignant melanoma or other neoplasia in the selected treatment area.
within 10 cm of a suspected BCC or SCC or other neoplasia
History or evidence of skin conditions other than the trial indication that would interfere with evaluation of the trial medication in the selected treatment area
...
History of SCC, BCC, malignant melanoma or other neoplasia in the selected treatment area.
within 10 cm of a suspected BCC or SCC or other neoplasia
History or evidence of skin conditions other than the trial indication that would interfere with evaluation of the trial medication in the selected treatment area
on the perioral skin/around the nostrils
within 5 cm of an incompletely healed wound
on the periorbital skin
Female subjects who are breastfeeding.
Selected treatment area lesions that have atypical clinical appearance (e.g., hypertrophic, hyperkeratotic or cutaneous horn).
Immunosuppressed subjects (for example HIV patients)
In the opinion of the investigator, the subject is unlikely to comply with the Clinical Study Protocol (e.g. alcoholism, drug dependency or psychotic state)
Use of ingenol mebutate and/or imiquimod in and within 5 cm of the selected treatment area within 2 years prior to Screening (Visit 1)
Organ transplant recipients
Subjects who are institutionalised by court order or by the local authority

Summary

Conditions
Actinic Keratosis (AK)
Type
Interventional
Phase
Phase 4
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Inclusion Criterias

Childbearing potential, provided there is a confirmed negative urine pregnancy test
Non-childbearing potential, or,
Subjects with 5 to 9 clinically typical, visible and discrete AKs within a contiguous 25 cm² treatment area on the face or scalp.
...
Childbearing potential, provided there is a confirmed negative urine pregnancy test
Non-childbearing potential, or,
Subjects with 5 to 9 clinically typical, visible and discrete AKs within a contiguous 25 cm² treatment area on the face or scalp.
Signed Informed Consent Form (ICF) prior to any trial-related procedures
Subject at least 18 years of age
Female subjects of childbearing potential must be willing to use highly effective methods of contraception (Pearl index < 1%)

Exclusion Criterias

History of SCC, BCC, malignant melanoma or other neoplasia in the selected treatment area.
within 10 cm of a suspected BCC or SCC or other neoplasia
History or evidence of skin conditions other than the trial indication that would interfere with evaluation of the trial medication in the selected treatment area
...
History of SCC, BCC, malignant melanoma or other neoplasia in the selected treatment area.
within 10 cm of a suspected BCC or SCC or other neoplasia
History or evidence of skin conditions other than the trial indication that would interfere with evaluation of the trial medication in the selected treatment area
on the perioral skin/around the nostrils
within 5 cm of an incompletely healed wound
on the periorbital skin
Female subjects who are breastfeeding.
Selected treatment area lesions that have atypical clinical appearance (e.g., hypertrophic, hyperkeratotic or cutaneous horn).
Immunosuppressed subjects (for example HIV patients)
In the opinion of the investigator, the subject is unlikely to comply with the Clinical Study Protocol (e.g. alcoholism, drug dependency or psychotic state)
Use of ingenol mebutate and/or imiquimod in and within 5 cm of the selected treatment area within 2 years prior to Screening (Visit 1)
Organ transplant recipients
Subjects who are institutionalised by court order or by the local authority

Locations

Dundee, Angus
Harrogate, North Yorkshire
Bobigny, 93009
Markkleeberg, 04416
Recklinghausen, 45657
...
Dundee, Angus
Harrogate, North Yorkshire
Bobigny, 93009
Markkleeberg, 04416
Recklinghausen, 45657
Hull
Münster, 48149
Wuppertal, 42105
Witten, 58453
Nantes, 44093
Scarborough, North Yorkshire
Regensburg, 93053
Würzburg, 97080
Besançon, 25030
Scunthorpe, Lincolnshire
Carlisle, Cumbria
Buxtehude, 21614
Poitiers, 86021
Leipzig, 04103
Bochum, 44791
Saint-Etienne, 42055
Leeds, West Yorkshire
Buchholz, 21244
Paris, 75006
Airdrie, Lanarkshire
Lille, 59037
Newport, Monmouthshire
Brest, 29609
Berlin, 10827
Bradford, West Yorkshire
Angers, 49933
Grenoble, 38043
Exeter, Devon
Shoreham-by-Sea, West Sussex
Pessac, 33604
Brighton, East Sussex
Hamburg, 22391
Paris, 75475
St Mandé, 94160
Redhill, Surrey
Dortmund, 44137
Cannock, Staffordshire
Nimes, 30029
Marseille, 13385
Nice, 06202
Manchester, Greater Manchester

Tracking Information

NCT #
NCT01926496
Collaborators
Not Provided
Investigators
  • Principal Investigator: Rolf-Markus Szeimies, Prof.Dr.med. Klinik für Dermatologie und Allergologie
  • Rolf-Markus Szeimies, Prof.Dr.med. Klinik für Dermatologie und Allergologie