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Completed

NCT Number: NCT05937529

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

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.

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Key information

Conditions

Actinic Keratoses Keratosis Keratosis, Actinic Neoplasms Precancerous Conditions Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bispebjerg Hospital

Copenhagen NV, 2400, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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

  • 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)

Treatment and study plan

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.

Other names: Cicaplast Baume B5+

Daylight PDT

Other

Daylight PDT performed with 2 hours of artifical indoor light.

Primary outcomes

  1. 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

    Time frame: 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

  2. 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

    Time frame: Evaluated at baseline and at day 30

    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.

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

    Time frame: From baseline to day 30

    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.

Secondary outcomes

  1. changes in the skin barrier function from baseline to day 30

    Time frame: from baseline to day 30

    Skin barrier function is assessed by measurements of trans-epidermal water loss (TEWL) with DermaLab, Cortex Technology, Hadsund, Denmark. Patients will be adjusted to room temperature before TEWL measurements, and skin pH will be measured using a pH-meter from DermaLab, Cortex Technology, Hadsund, Denmark. All measurements will be performed in triplicates and median value will be calculated.

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

    Time frame: From baseline to day 30

    The level of erythema and melanin will be estimated at the treatment areas in the face or the décolleté using the CE-marked Skin Colormeter DSM.

    In addition, erythema and melanin will be estimated in the face using the VISIA, Canfield imaging system, Fairfield, NJ, USA. VISIA uses standard incandescent light, ultraviolet (UV) and cross-polarized light, and generates a series of high-resolution images to determine the patient's overall skin condition. The images will be analyzed with Canfield's software RBX Technology.

  3. Pain during PDT treatment

    Time frame: During the procedure

    Will be evaluated by the patient on a numerical scale 0-10: 0 = none, 10 = worst imaginable pain

  4. Pain in the treatment areas

    Time frame: from day 1 to day 30

    Pain will be evaluated by the patient from day 1 to day 30 by completing a diary with information on pain in the Cicaplast Baume B5+ treated area vs. the non-post-treated area . The scale 0-10: 0 = none, 10 = worst imaginable pain will be used.

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

    Time frame: from day 1 to day 30

    Patients will be asked to evaluate the incidence of prutitus in Cicaplast Baume B5+ treated area and the non-post-treated area. Pruritus will be evaluted on the scale 0-3: 0 = none, 1 = light, 2 = moderate, 3 = severe

  6. Patients satisfaction with the treatment of daylight PDT + Cicaplast Baume B5+ compared to daylight PDT alone

    Time frame: from baseline to day 30

    Patients will be asked to evaluate their satisfaction with the treatment on a scale 0-10: 0 = could not be more unsatisfied, 10 = could not be more satisfied

Sponsors and collaborators

Lead sponsor

Merete Haedersdal

Other

Collaborators

  • L'Oreal

Registry information

Official study title

Impact of a Cream Containing Madecassoside and 5 % Panthenol in Post Photodynamic Therapy Procedure for Actinic Keratosis: A Randomized, Controlled Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 10, 2023
Registry last updated
May 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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