Impact of Madecassoside and 5 % Panthenol Cream in Post Photodynamic Therapy for Actinic Keratosis

Merete Haedersdal

Status: Completed

Conditions: Actinic Keratoses

Treatments: Other: Daylight PDT; Other: Cream containing madecassoside and 5 % panthenol

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05937529

H-23015740

Details and patient eligibility

About

Premalignant AKs are highly frequent in the light-skinned populations with an increasing incidence. PDT is considered a well-establish treatment for these lesions, and therefore it is essential to achieve an optimal and effective treatment as possible. The present study proposes a new post-treatment modality with application of an anti-inflammatory moisturizer Cicaplast Baume B5+ to the treated areas that may improve the overall patient satisfaction and minimize the local skin reactions. Treatment regime consists of two daily applications of Cicaplast Baume B5+ for 14 days, and this regime is not associated with increased risk of systemic AEs or serious events.

Enrollment: 20 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Signed informed consent
2. > 18 years of age or older at baseline
3. Fitzpatrick skin type I-III
4. Clinical AKs in two symmetrical areas on the face or on the chest, presented with at least ten AKs
5. Female subjects of childbearing potential must be confirmed not pregnant by negative pregnancy test prior to study inclusion and must use a safe contraceptive method during the study

Exclusion criteria

1. Previous exposure to PDT, energy-based devices, or AK treatment on the study areas within 3 months
2. Pregnant or lactating women
3. Patients with known allergy to MAL or any ingredients in Cicaplast, Baume B5+
4. Concomitant treatment with immunosuppressant drugs
5. Infiltrating tumors in the treatment areas
6. Known porphyria
7. Other skin diseases present in the test area at baseline
8. Non-eligibility at the discretion of the investigator (e.g. non-compliance, unavailability or other reasons the subject is not believed to be able to comply with the clinical trial protocol)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Daylight PDT + Cicaplast

Experimental group

Description:

Pretreatment with currettage. Metvix cream. Daylight PDT. Application of Cicaplast to test area immediately after dPDT. Cicaplast application twce daily for 14 days.

Treatment:

Other: Cream containing madecassoside and 5 % panthenol

Other: Daylight PDT

Daylight PDT

Active Comparator group

Description:

Pretreatment with currettage. Metvix cream. Daylight PDT. No post treatment.

Treatment:

Other: Daylight PDT