Removal of seborrheic keratoses: curettage vs. 532-nm LBO laser vs. cryospray

Phase 4

• Conditions: L82; Seborrhoeic keratosis

• Registration Number: DRKS00021689
• Lead Sponsor: Praxis Prof. Krengel/ Haase/ Mrowka

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2020-11-11
• Study Start: 2021-02-10
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1) The patient is at least 18 years old.
2) The clinical diagnosis of seborrheic keratosis is confirmed.
3) The patient has at least three seborrheic keratoses suitable for treatment.
4) The patient is not pregnant and is not breastfeeding.
5) The patient is in good health with no current ailments. This includes other skin diseases that could affect the assessment of a target lesion or place the patient at risk of complications.
6) The patient is able to follow study instructions and participate in all study appointments.
7) The patient is able to understand and sign the declaration of consent.

Exclusion Criteria

1) The patient has an atypical seborrheic keratoses where the diagnosis is uncertain.
2) The patient is pregnant and / or breastfeeding.
3) The patient has a skin disease that is either flurid or not controlled (e.g. psoriasis, eczema) or a skin condition (sunburn) which, in the opinion of the investigator, would impair the condition or endanger the patient if he or she participated in the study.
4) The patient used one of the following systemic therapies within the specified period (30 days) before enrollment: retinoids, glucocorticosteroids, Anti-metabolites. (e.g. methotrexate)
5) The patient received one of the following therapies within the specified period of time or close to the target lesion: laser, light or other energy-based therapy (e.g. intense pulsed light, photodynamic therapy; liquid nitrogen, electrode cauterization), Curettage, imiquimod, 5-flurouracil or ingenol mebutate, retinoids, microdermabrasion or superficial chemical peels, topical or systemic glucocorticosteroids, antibiotics.
6)The patient has presented with a cutaneous malignancy, a pre-malignancy (e.g actinic keratosis), sunburn, an excessive tan or body art (tattoos, piercing, etc) as this may have a detrimental effect on treatment outcomes or hinder pre and post-treatment analysis.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient satisfaction: Which of the three methods would the patient prefer for future treatment? The primary outcome is assessed via questionnaire at the day of the treatment of the patient and after 4, 8 and 12 weeks.

Secondary Outcome Measures

Name	Time	Method
Compare healing rates and record the medical assessment of the results at the day of the treatment and after 4, 8 and 12 weeks. Furthermore ask a blinded observer at the end of the study via photographic recordings about the best outcome.