Clinical TrialID 8291
Impact of Madecassoside and 5 % Panthenol Cream in Post Photodynamic Therapy for Actinic Keratosis
NCT05937529
Actinic Keratoses
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 8291
- Evidence Id
- 8291
- Core Evidence Id
- 8291
- Source Clinical Trial Id
- 8289
- Herb2 Clinical Trial Id
- HBCT008289
- Nct Id
- NCT05937529
- Title
- Impact of Madecassoside and 5 % Panthenol Cream in Post Photodynamic Therapy for Actinic Keratosis
- Status
- Completed
- Phase
- Study Result
- No
- Study Condition
- Actinic Keratoses
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
- Intervention
- OTHER: Cream containing madecassoside and 5 % panthenol|OTHER: Daylight PDT
- Intervention Allocation
- Randomized
- Intervention Model
- Parallel
- Intervention Mask
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Adult, Older_Adult
- Enrollment
- 20
- Outcome 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, 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
- Sponsor Collaborator
- Merete Haedersdal|L'Oreal
- Funded By
- OTHER
- Location
- Bispebjerg Hospital, Copenhagen NV, 2400, Denmark
- Other Id
- H-23015740
- Start Date
- 2023-09-27
- Primary Completion Date
- 2024-02-29
- Completion Date
- 2024-02-29
- First Posted
- 2023-07-10
- Results First Posted
- Last Update Posted
- 2024-05-08
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT05937529
- Title Cn
- Title En
- Impact of Madecassoside and 5 % Panthenol Cream in Post Photodynamic Therapy for Actinic Keratosis
- Bilingual Status
- semi_complete