Clinical trial NCT05937529: Impact of Madecassoside and 5 % Panthenol Cream in Post Photodynamic Therapy for Actinic Keratosis
Official title: Impact of a Cream Containing Madecassoside and 5 % Panthenol in Post Photodynamic Therapy Procedure for Actinic Keratosis: A Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Actinic Keratoses
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: L'Oreal
First posted: 2023-07-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, intraindividual controlled trial
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: 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
timeFrame: From baseline to day 30
measure: 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
timeFrame: Evaluated at baseline and at day 30
measure: Changes in local skin responses after PDT in Cicaplast Baume B5+ treated skin vs. non-post-treated skin
timeFrame: From baseline to day 30
Secondary outcomes:
measure: changes in the skin barrier function from baseline to day 30
timeFrame: from baseline to day 30
measure: Changes in pigmentation and redness of the skin from baseline to day 30
timeFrame: From baseline to day 30
measure: Pain during PDT treatment
timeFrame: During the procedure
measure: Pain in the treatment areas
timeFrame: from day 1 to day 30
measure: Incidence of prutitus in the treatment areas from day 1 to day 30
timeFrame: from day 1 to day 30
measure: Patients satisfaction with the treatment of daylight PDT + Cicaplast Baume B5+ compared to daylight PDT alone
timeFrame: from baseline to day 30
Other outcomes:
Locations:
city: Copenhagen NV
country: Denmark
facility: Bispebjerg Hospital
Study officials:
affiliation: Department of Dermatology Bispebjerg Hospital
name: Merete Hædersdal, MD PhD DMSc
role: PRINCIPAL_INVESTIGATOR
References: