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

NCT05937529 | Completed

• 1 other identifier: H-23015740
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Actinic Keratoses

Outcome Measures

Primary Outcomes (3)

• Changes in clinically assessed local skin responses after PDT in Cicaplast Baume B5+ treated skin vs. non-post-treated skin from baseline to day 30

  Clinical evaluation of erythema, edema, and crusting will be done in the two treatment areas at all visits and scored on a four-point scale (0-3): None, mild, moderate, or severe

  From baseline to day 30

• Evaluation of AK identification and grading before PDT and following PDT treatment in skin treated with Cicaplast Baume B5+ treated skin vs. non-post-treated skin

  Evaluation of clinical response including AK identification and grading will be performed by trained physicians at baseline and at follow-up visits. AK identification and grading will be performed according to Olsen grade classification system: * Grade I: Flat, pink maculae without signs of hyperkeratosis and erythema often easier felt than seen * Grade II: Moderately thick hyperkeratosis on background of erythema that easily felt and seen * Grade III: Very thick hyperkeratosis Occurrence of new AKs in the treatment areas will be recorded at day 30 using the baseline template. The number and severity of the new lesion in the treatment areas will be recorded.

  Evaluated at baseline and at day 30

• Changes in local skin responses after PDT in Cicaplast Baume B5+ treated skin vs. non-post-treated skin

  OCT system will be used to visualize the epidemis and upper dermis and changes in the cutanous microvascular morphology. All images will be evaluated qualitatively and quantitively using the integrated OCT software.

  From baseline to day 30

Secondary Outcomes (6)

• changes in the skin barrier function from baseline to day 30

  from baseline to day 30

• Changes in pigmentation and redness of the skin from baseline to day 30

  From baseline to day 30

• Pain during PDT treatment

  During the procedure

• Pain in the treatment areas

  from day 1 to day 30

• Incidence of prutitus in the treatment areas from day 1 to day 30

  from day 1 to day 30

Study Arms (2)

Daylight PDT + Cicaplast

EXPERIMENTAL

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

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

Daylight PDT

ACTIVE COMPARATOR

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

Other: Daylight PDT

Interventions

Cream containing madecassoside and 5 % panthenol OTHER

Immediately after daylight PDT, Cicaplast is administrated as post treatment. The patients are instructed to apply the cream twice daily for 14 days.

Also known as: Cicaplast Baume B5+

Daylight PDT + Cicaplast

Daylight PDT OTHER

Daylight PDT performed with 2 hours of artifical indoor light.

Daylight PDT; Daylight PDT + Cicaplast

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent
• \> 18 years of age or older at baseline
• Fitzpatrick skin type I-III
• Clinical AKs in two symmetrical areas on the face or on the chest, presented with at least ten AKs

You may not qualify if:

• Previous exposure to PDT, energy-based devices, or AK treatment on the study areas within 3 months
• Pregnant or lactating women
• Patients with known allergy to MAL or any ingredients in Cicaplast, Baume B5+
• Concomitant treatment with immunosuppressant drugs
• Infiltrating tumors in the treatment areas
• Known porphyria
• Other skin diseases present in the test area at baseline
• 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)

Sponsors & Collaborators

• Merete Haedersdal: lead
• L'Oreal: collaborator

Study Sites (1)

Bispebjerg Hospital

Copenhagen NV, 2400, Denmark

Location

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

dexpanthenol

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Merete Hædersdal, MD PhD DMSc

  Department of Dermatology Bispebjerg Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, PhD., dr. med.

Model Details: A randomized, intraindividual controlled trial

Study Record Dates

• First Submitted: June 8, 2023
• First Posted: July 10, 2023
• Study Start: September 27, 2023
• Primary Completion: February 29, 2024
• Study Completion: February 29, 2024
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

DK (1)