Photodynamic Therapy of Actinic Keratosis of the Face and Scalp With and Without Prior Curettage

Phase 4

Completed

• Conditions: Keratosis, Actinic
• Interventions: Drug: No curettage; Drug: Curettage

• Registration Number: NCT03697590
• Lead Sponsor: Bispebjerg Hospital

Brief Summary

Guidelines for photodynamic therapy (PDT) of actinic keratosis recommend pretreatment with curettage. The impact of curettage on the treatment effect is, however, not known. The present study aimed to evaluate whether daylight-PDT without curettage would reduce treatment effect compared to daylight-PDT with curettage.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-06
• Study Start: 2017-06-01
• Primary Completion: 2017-12-20
• Study Completion: 2017-12-20
• Study First Submitted: 2018-10-04
• Study First Submitted QC: 2018-10-04
• Study First Posted: 2018-10-05
• Last Update Submitted: 2018-10-05
• Last Update Posted: 2018-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Multiple actinic keratosis on the forehead or scalp

Exclusion Criteria

• Known allergy to methyl aminolevulinate
• Porphyria
• Pregnancy
• Lactation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PDT with no curettage	No curettage	-
Standard PDT	Curettage	-

Primary Outcome Measures

Name	Time	Method
Complete lesion response rate	Treatment efficacy was evaluated 3 months after PDT	Complete lesion response rate, was defined as the number of completely responding lesions divided by the total number of treated lesion in each field. Complete lesion response was defined as complete disappearance of the lesion both by palpation and visually.

Trial Locations

Locations (1)

Bispebjerg Hospital; 🇩🇰 Copenhagen NV, DK, Denmark