Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02281682
Other study ID # NL50621.068.14
Secondary ID 8360310112014-00
Status Active, not recruiting
Phase Phase 4
First received October 28, 2014
Last updated October 27, 2017
Start date November 2014
Est. completion date December 2018

Study information

Verified date October 2017
Source Maastricht University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A multi-centre randomised controled single blind clinical phase IV trial with the aim to determine the most effective treatment in terms of lesion reduction, costs and patient satisfaction in treatment of actinic keratosis (AK), when comparing topical treatment with photodynamic therapy (PDT), 5% 5-fluorouracil (5-FU) cream, 5% Imiquimod (IMI) cream and ingenol mebutate (IM) gel.


Description:

Skin cancer is the most common cancer in Caucasians and therefore a major public health issue. Its incidence is increasing rapidly. Actinic keratosis (AK) is the most prevalent precancerous chronic skin condition. It can transform into squamous cell carcinoma (SCC). AK's generally arise in a skin area that has diffuse precancerous damage, a phenomenon called field cancerization. Because of its precancerous character, it is advised to treat AK and herewith prevent development into SCC. The most frequently used field-directed treatments in the Netherlands are photodynamic therapy (PDT), topical 5% f-fluorouracil (5% 5-FU) and topical 5% Imiquimod (5% IMI). Lately another topical product is approved by Dutch healthcare insurances: Ingenol mebutate (IM). Up to date, which treatment the patient will receive, does not rely on evidence-based-medicine, but generally on the preference of the physician. Current national and international guidelines state no clear recommendations for the best choice of therapy. The aim of this study determine which treatment is the most effective treatment in terms of lesion reduction, costs and patient satisfaction when comparing topical treatment with photodynamic therapy (PDT), 5% 5-fluorouracil (5-FU) cream, 5% Imiquimod (IMI) cream and ingenol mebutate (IM) gel, in treatment of actinic keratosis (AK).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 624
Est. completion date December 2018
Est. primary completion date July 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients older than 18 years

- Fitzpatrick skintype I-IV

- Clinically confirmed diagnosis of AK

- One joint area of minimal 25 cm2 and maximal 100 cm2 of AK

- Minimum of 5 AK lesions

- AK Olsen grade I-III

- Location: head/neck area

Exclusion Criteria:

- Received any kind of treatment for AK in the past 3 months

- (non)melanoma skin cancer in target area

- Immuno-compromised status

- Use of systemic retinoid in the past 3 months

- Use of immunosuppressant drugs in the past 3 months and / or at time of treatment (such as oral glucocorticoids, cytostatic, antibodies, drug acting on immunophilins, interferon, opioids, Tumor Necrosis Factor (TNF) binding proteins, mycofenolate mofetil (MMF), biologic agents). inhalation corticosteroids / nasal corticosteroids are permitted.

- Porphyria

- Not able to give informed consent

- Allergy to study drugs or peanut/nut/soy products

- Pregnant and breastfeeding women

- Female in child bearing potential not using contraceptive measures, during and till 3 months post-treatment

- Genetic skin cancer disorders

- Not understanding Dutch language

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Imiquimod
three times a week once daily during 4 consecutive weeks. Prior to treatment: curettage
5-fluorouracil
during 4 (consecutive) weeks twice daily. Prior to treatment: curettage
Ingenol mebutate
during 3 (consecutive) days once daily. Prior to treatment: curettage
Procedure:
methylaminolevulinate photodynamic therapy
methylaminolevulinate photodynamic therapy; one session. Prior to treatment: curettage

Locations

Country Name City State
Netherlands Maastricht UMC Maastricht Limburg

Sponsors (1)

Lead Sponsor Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary treatment succes the proportion of patients with =75% lesion reduction in the number of AK lesions counted at baseline in the treatment area 12 months post final treatment (= 75% patient clearance at 12 months). 12 months
Secondary treatment failure proportion of participants with <75% reduction in number of AK lesions after 3 and 12 months post final treatment compared to baseline (<75% patient clearance at 3 and 12 months). 12 months
Secondary Treatment succes at 3 months post treatment proportion of participants with =75% reduction in number of AK lesions at 3 months post final treatment (= 75% patient clearance at 3 months). 3 months
Secondary complete lesion clearance proportion of lesions with 100% clearance in all treated patients at 3 and 12 months post final treatment. 12 months
Secondary SCC Proportion of patients who develop a SCC in the treatment area during study follow-up. 12 months
Secondary side effects local skin reactions reported in patient diary, visual analogue score (VAS), Patient-reported adverse events 12 months
Secondary Cosmetic outcome based on a Cosmetic questionnaire, filled in on baseline, 3 + 12 months 3 and 12 months
Secondary patient satisfaction Skindex-29 questionnaire (quality of life) , Actinic Keratosis Quality of Life (AKQoL) questionnaire; filled in on baseline, 3 + 12 months 12 months
Secondary treatment compliance defined as the number of applied treatments as percentage of the number of prescribed treatments, based on patient diaries and weighing returned medication. 3 months
Secondary Overall decrease in AK Decrease in number AK from baseline per patient, at 3 and 12 months post final treatment. 3 and 12 months
Secondary Cost-effectiveness Healthcare/treatment costs 12 months
Secondary Investigator Global Improvement Indices Investigator Global Improvement Indices (IGII) at 3 and 12 months post final treatment. 3 and 12 months
Secondary Number of new lesions Number of new lesions at 3 and 12 months post final treatment 3 and 12 months
See also
  Status Clinical Trial Phase
Completed NCT03076892 - Evaluation of Non-inferiority and Tolerability of the Device PHOS-ISTOS N/A
Terminated NCT03076918 - Evaluating the Device FLEXITHERALIGHT Compared to the Conventional Photodynamic Therapy N/A
Completed NCT05356572 - A Pre-market Study to Evaluate the Performance and Safety of a Skin Preparation Device for Removal of Dry Crusty Skin N/A
Recruiting NCT05387525 - A Study of Tirbanibulin Ointment and Diclofenac Sodium Gel for the Treatment of Adult Participants With Actinic Keratosis on the Face or Scalp Phase 4
Completed NCT02594644 - The Use of Microneedles to Expedite Treatment Time in Photodynamic Therapy N/A
Completed NCT01458587 - Levulan PDT Versus Vehicle for Extremity Actinic Keratoses (AK) Phase 2
Completed NCT05260073 - Patient and Clinician Reported Outcomes for Tirbanibulin Effectiveness and Safety in Actinic Keratosis
Active, not recruiting NCT06014697 - OCT and Invasion in Cutaneous Skin Lesions
Completed NCT05279131 - A Study to Evaluate the Safety and Tolerability of Tirbanibulin Ointment 1% in Adult Participants With Actinic Keratosis Phase 3
Completed NCT05481073 - UV Sensor in Patients With Actinic Keratosis
Completed NCT03697590 - Photodynamic Therapy of Actinic Keratosis of the Face and Scalp With and Without Prior Curettage Phase 4
Withdrawn NCT02813902 - A Trial of Polypodium Leucotomos in Preventing Skin Cancer and Its Precursors Phase 1
Recruiting NCT05636800 - Microwave Treatment for Actinic Keratosis N/A
Completed NCT02628236 - Maximal Use Systemic Exposure Study of Levulan Kerastick (MUSE 2) Phase 2
Recruiting NCT06135415 - A Study to Evaluate the Efficacy and Safety of Tirbanibulin Ointment in Adult Participants With Actinic Keratosis Phase 3
Completed NCT02644187 - Pain Relief During Photodynamic Therapy for Actinic Keratoses With a New Irradiation Protocol N/A
Completed NCT02281136 - MUSE Study of Levulan Kerastick Phase 2
Completed NCT05060237 - Study to Evaluate Safety and Tolerability of BF-200 ALA (Ameluz®) for Photodynamic Therapy in the Treatment of the Expanded Field of Actinic Keratosis on Face and Scalp Phase 1
Terminated NCT04269395 - A Study to Assess Recurrence of Actinic Keratosis in Participants Treated With Methyl Aminolevulinate Hydrochloride Cream or Vehicle Cream Who Achieved Complete Response to Treated Lesions in Earlier Study Phase 3