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

Keratosis, Actinic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03697590
• Other study ID #: PDT with and without curettage
• Status: Completed
• Phase: Phase 4
• Start date: June 1, 2017
• Est. completion date: December 20, 2017

Study information

• Verified date: June 2017
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 20, 2017
• Est. primary completion date: December 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Multiple actinic keratosis on the forehead or scalp

Exclusion Criteria:

• Known allergy to methyl aminolevulinate

• Porphyria

• Pregnancy

• Lactation

Related Conditions & MeSH terms

• Keratosis
• Keratosis, Actinic

Intervention

Drug:
• No curettage
Standard PDT without curettage
• Curettage
Standard PDT

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital	Copenhagen NV	DK

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete lesion response rate	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.	Treatment efficacy was evaluated 3 months after PDT