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

Primary Purpose

Actinic Keratoses

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Cream containing madecassoside and 5 % panthenol
Daylight PDT
Sponsored by
Merete Haedersdal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Actinic Keratoses

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Bispebjerg HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Daylight PDT + Cicaplast

Daylight PDT

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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.
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.

Secondary Outcome Measures

changes in the skin barrier function 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.
Changes in pigmentation and redness of the skin 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.
Pain during PDT treatment
Will be evaluated by the patient on a numerical scale 0-10: 0 = none, 10 = worst imaginable pain
Pain in the treatment areas
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.
Incidence of prutitus in the treatment areas 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
Patients satisfaction with the treatment of daylight PDT + Cicaplast Baume B5+ compared to daylight PDT alone
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

Full Information

First Posted
June 8, 2023
Last Updated
October 20, 2023
Sponsor
Merete Haedersdal
Collaborators
L'Oreal
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1. Study Identification

Unique Protocol Identification Number
NCT05937529
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 27, 2023 (Actual)
Primary Completion Date
August 20, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Merete Haedersdal
Collaborators
L'Oreal

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratoses

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomized, intraindividual controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Daylight PDT + Cicaplast
Arm Type
Experimental
Arm Description
Pretreatment with currettage. Metvix cream. Daylight PDT. Application of Cicaplast to test area immediately after dPDT. Cicaplast application twce daily for 14 days.
Arm Title
Daylight PDT
Arm Type
Active Comparator
Arm Description
Pretreatment with currettage. Metvix cream. Daylight PDT. No post treatment.
Intervention Type
Other
Intervention Name(s)
Cream containing madecassoside and 5 % panthenol
Other Intervention Name(s)
Cicaplast Baume B5+
Intervention Description
Immediately after daylight PDT, Cicaplast is administrated as post treatment. The patients are instructed to apply the cream twice daily for 14 days.
Intervention Type
Other
Intervention Name(s)
Daylight PDT
Intervention Description
Daylight PDT performed with 2 hours of artifical indoor light.
Primary Outcome Measure Information:
Title
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
Description
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
Time Frame
From baseline to day 30
Title
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
Description
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.
Time Frame
Evaluated at baseline and at day 30
Title
Changes in local skin responses after PDT in Cicaplast Baume B5+ treated skin vs. non-post-treated skin
Description
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.
Time Frame
From baseline to day 30
Secondary Outcome Measure Information:
Title
changes in the skin barrier function from baseline to day 30
Description
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.
Time Frame
from baseline to day 30
Title
Changes in pigmentation and redness of the skin from baseline to day 30
Description
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.
Time Frame
From baseline to day 30
Title
Pain during PDT treatment
Description
Will be evaluated by the patient on a numerical scale 0-10: 0 = none, 10 = worst imaginable pain
Time Frame
During the procedure
Title
Pain in the treatment areas
Description
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.
Time Frame
from day 1 to day 30
Title
Incidence of prutitus in the treatment areas from day 1 to day 30
Description
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
Time Frame
from day 1 to day 30
Title
Patients satisfaction with the treatment of daylight PDT + Cicaplast Baume B5+ compared to daylight PDT alone
Description
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
Time Frame
from baseline to day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gabriella Fredman, MD
Phone
+4524231595
Email
gabriella.louise.fredman@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merete Hædersdal, MD PhD DMSc
Organizational Affiliation
Department of Dermatology Bispebjerg Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bispebjerg Hospital
City
Copenhagen NV
ZIP/Postal Code
2400
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Merete Hædersdal

12. IPD Sharing Statement

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

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