Clinical trial · Interventional
Impact of Madecassoside and 5 % Panthenol Cream in Post Photodynamic Therapy for Actinic Keratosis
Impact of a Cream Containing Madecassoside and 5 % Panthenol in Post Photodynamic Therapy Procedure for Actinic Keratosis: A Randomized, Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Actinic Keratoses | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cream containing madecassoside and 5 % panthenol | Other | — | UNRESOLVED |
| Daylight PDT | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Daylight PDT + Cicaplast
- description
- Pretreatment with currettage. Metvix cream. Daylight PDT. Application of Cicaplast to test area immediately after dPDT. Cicaplast application twce daily for 14 days.
- interventionNames
- Other: Cream containing madecassoside and 5 % panthenol
- Other: Daylight PDT
- type
- ACTIVE_COMPARATOR
- label
- Daylight PDT
- description
- Pretreatment with currettage. Metvix cream. Daylight PDT. No post treatment.
- interventionNames
- Other: Daylight PDT
Primary outcomes (3)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available