Clinical Trials Logo
  1. Home
  2. Actinic Keratosis
  3. NCT02090465
  4. Details
NCT02090465 Clinical Trial

Assessment of Treatment Success and Quality of Life in Patients With Actinic Keratoses Under Therapy With Ingenol Mebutate in a Period of 8 Weeks

Actinic Keratosis Clinical Trial

Official title:
Assessment of Treatment Success and Quality of Life in Patients With Actinic Keratoses Under Therapy With Ingenol Mebutate (Picato) in a Period of 8 Weeks.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02090465
Other study ID # DE-Picato NIS-2013
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 2013
Est. completion date December 2013

Study information
Verified date December 2019
Source LEO Pharma
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Assessment of treatment success and quality of life in patients with actinic keratoses under therapy with Ingenol Mebutate (Picato) in a period of 8 weeks.

Description:

Non-interventional (observational) study (NIS), non-controlled, prospective cohort study.

Recruitment information / eligibility
Status Completed
Enrollment 840
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

• Non-hyperkeratotic, non-hypertrophic actinic keratoses where treatment with Picato® is indicated and the treatment is intended by physicians.

Exclusion Criteria:

- Preceding use of Picato® on the area planned for treatment

- Any other specific local treatment of actinic keratoses on the area planned for treatment during the last 8 weeks

- Melanoma, squamous cell carcinoma or spinalioma on the area planned for treatment

- Open wounds on the area planned for treatment

- Contraindications according to prescribing information

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Ingenol Mebutate
No intervention: observation of routine use of Picato®

Locations
Country Name City State
Germany Universitätsklinikum Heidelberg/Klinische Sozialmedizin Heidelberg

Sponsors (1)
Lead Sponsor Collaborator
LEO Pharma

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Actinic keratosis Documentation of the course of actinic keratoses and skin findings during ambulant routine use of Picato® 8 weeks
Primary Skindex-16 Patient' s quality of life during ambulant routine use of Picato® 8 weeks
Primary Dosage of Picato® Prescribed and applied dosages and adherence during ambulant routine use of Picato® 8 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT03013647 - Daylight Photodynamic Therapy for Actinic Keratosis and Skin Field Cancerization N/A
Completed NCT02674048 - Metvix Daylight PDT in Actinic Keratosis
Completed NCT02421471 - PMS to Evaluate the Safety and Efficacy of Picato® Gel
Completed NCT02239679 - Controlled Study of the Occurrence of Actinic Keratosis on the Face After Cryotherapy + Aminolevulinic Acid (ALA) Photodynamic Therapy Phase 2
Completed NCT01686152 - Study Comparing Imiquimod Cream, 3.75% to Zyclara® (Imiquimod) Cream, 3.75% in the Treatment of Actinic Keratosis Phase 3
Completed NCT01449513 - PEP005 Gel - Biological Effects in Actinic Keratosis Assessed by Reflectance Confocal Microscopy Phase 1
Completed NCT01444989 - Development and Validation of a Quality of Life Instrument for Actinic Keratosis N/A
Terminated NCT01525329 - Combination Therapy With 5-Fluorouracil and Photodynamic Therapy in Post-transplant Premalignant Skin Disease Phase 3
Terminated NCT01203878 - Treatment of Actinic Keratoses of the Face With Imiquimod 3.75% Cream Followed by Photodynamic Therapy Phase 4
Completed NCT00989313 - A Long Term Follow up Study of Patients Who Have Complete Clearance of Their Actinic Keratosis (AK) Lesions at the Day 57 Visit in the PEP005-028 Study Phase 3
Completed NCT00306800 - Metvix PDT Versus Vehicle PDT With Aktilite CL128 Lamp in Patients With Actinic Keratosis on the Face and Scalp Phase 3
Completed NCT00375739 - Study to Determine the Safety of PEP005 0.025% and 0.05% Topical Gel in Patients With Actinic Keratoses Phase 2
Completed NCT03285490 - A Multi-Center Study to Evaluate the Efficacy and Safety of KX2-391 Ointment 1% on Actinic Keratosis on Face or Scalp (AK004) Phase 3
Completed NCT03319251 - Biomarker Database Registry for Photodynamic Therapy
Completed NCT02866695 - Safety and Efficacy of Ingenol Mebutate Gel 0.015% for Treatment of AK on the Face in Solid Organ Transplant Recipients Phase 4
Completed NCT02952898 - Study Comparing GDC 695 and Diclofenac Sodium Gel, 3% in Subjects With Actinic Keratoses Phase 3
Completed NCT02984072 - Menthol for PDT Pain Relief Phase 4
Recruiting NCT03684772 - Topical Ionic Contra-Viral Therapy in Actinic Keratosis Phase 2
Completed NCT02902822 - Tele-dermatology of Skin Cancer in a Cohort of Local Health Authority Employees in the Province of Bergamo N/A
Completed NCT02938715 - Pilot Study of the Pragmatic Use of Mobile Phone Based Follow up of Actinic Keratoses Treated With Topical 5-fluorouracil N/A