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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-27

Study Completion Date

2024-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Photodynamic Therapy of Actinic Keratosis of the Face and Scalp With and Without Prior Curettage

NCT03697590

Keratosis, Actinic

COMPLETED PHASE4

PD P 506 A-PDT Versus Placebo-PDT and Cryosurgery for the Treatment of AK

NCT00308867

Actinic Keratosis

COMPLETED PHASE3

Daylight PDT for Actinic Keratoses: a Multicentre Study Comparing Two Photosensitizers (BF-200 ALA Versus MAL)

NCT02464709

Actinic Keratosis Natural Daylight Photodynamic Therapy

COMPLETED PHASE4

Topical PDT Cream Without Irradiation Source in the Acne Treatment

NCT02313467

Acne, Photodynamic Therapy

COMPLETED NA

Indoor Daylight Photodynamic Therapy is an Effective, First-line Treatment for AK, But Its Feasibility is Limited by the Time Required for the Illumination (2 Hours). Our Objective Was to Evaluate the Efficacy of Idl-PDT With an Illumination Time of 1 Hour Versus 2 Hours in the Treatment of Scalp AK

NCT07290959

Actinic Keratosis (AK)

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Actinic Keratoses

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomized, intraindividual controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Daylight PDT + Cicaplast

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

Group Type EXPERIMENTAL

Cream containing madecassoside and 5 % panthenol

Intervention Type OTHER

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

Daylight PDT

Intervention Type OTHER

Daylight PDT performed with 2 hours of artifical indoor light.

Daylight PDT

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

Group Type ACTIVE_COMPARATOR

Daylight PDT

Intervention Type OTHER

Daylight PDT performed with 2 hours of artifical indoor light.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cream containing madecassoside and 5 % panthenol

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

Daylight PDT

Daylight PDT performed with 2 hours of artifical indoor light.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Cicaplast Baume B5+

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No