Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Wounds and Injuries

Breast Neoplasms

Radiodermatitis

Dermatitis

Skin Diseases

Radiation Injuries

Dermatologic Agents

All Drugs and Chemicals

Calcipotriene

Calcipotriol

Eyal Fenig, M.D.

Ofer Purim, M.D.

Amir Abramovich, M.D.

Examining the hypothesis that protecting keratinocytes by calcipotriol can prevent in-vivo cutaneous side effect in patients receiving radiotherapy to the breast.

To check the connection between the skin effect of radiotherapy and different parameters including diseases such as diabetes and lupus, use of medications, allergies, weight, habits, size of the irradiated breast, previous chemotherapy treatment and exposure to sunlight.

STUDY PROTOCOL

Fifty women diagnosed with breast cancer planned to receive adjuvant radiotherapy, will participate in the study. About 15 minutes after receiving the daily radiation dose fraction, a cream containing an active vitamin D analogue will be applied to half of the breast with inspection of a nurse. The other half of the breast will have a standard cream applied . During the days that radiotherapy is not administered the standard cream will be applied to both halves of the breast in a case of strong reaction to radiotherapy (e.g. strong erythema, painful tenderness etc.)The adverse skin effects will be assessed according to the following criteria:

1. . an assessment by a physician and a nurse according to the RTOG score (6).

   As follows:

   Grade 0 - no reaction. Grade 1 - light erythema dry peeling, decrease in sweat production. Grade 3 - extensive moist peeling, pitting edema. Grade 4 - ulcers, bleeding and necrosis.
2. . A questionnaire to each patient regarding the efficacy and safety of the cream.
3. . Number of interruption of radiotherapy treatment. The assessment will be done each week during radiotherapy treatment and weekly for three weeks following the completion of radiotherapy treatment.

Safety report will be sent to the local independent ethics committee after the examination of the first ten patients.

The protective effect of the cream containing calcipotriol will be compared to the standard treatment and analyzed statistically using the parameters mention above. The relation between the background disease, medications, allergies, weight, habits, size of the irradiated breast, sun exposure, previous chemotherapy treatment and exposure to sunlight and the skin reaction will be evaluated.

INCLUSION CRITERIA

1. . Age ranging from 18 to 75.
2. . Confirmed histological diagnosis of Breast cancer.
3. . Radiotherapy treatment to the breast following lumpectomy.

EXCLUSION CRITERIA

1. . Scleroderma.
2. . An extremely large breast. Interfiled above 25 cm.
3. . Prior radiotherapy to the same breast, radiotherapy to the contra lateral breast is not a contraindication.
4. . Mastectomy.

The Role of Calcipotriol as Radioprotector of Skin

Phase 2 Study of the Role of Calcipotriol as Radioprotector of Skin in Women Receiving Radiotherapy Treatment to the Breast.

Rabin Medical Center

Keratosis, Actinic

Keratosis

Skin Neoplasms

Precancerous Conditions

Bone Density Conservation Agents

Micronutrients

Vitamins

Vitamin D

Cholecalciferol

Methyl 5-aminolevulinate

Vitamin D3

Calciferol

Conventional topical PDT with Methylaminolevulinate 16% in one half of the scalp with multiple AKs.

Calcipotriol ointment 50 mcg/g applied once a day for 15 consecutive days in one half of the scalp, before Conventional topical PDT

Curettage of lesions and application of MAl cream 16% for 90 minutes under occlusion followed by LED 635 nm illumination at 37 J/cm2 total dose

Conventional MAL-PDT

Calcipotriol 50 mcg/g for 15 days prior to PDT. Curettage of lesions and application of MAl cream 16% for 90 minutes under occlusion followed by LED 635 nm illumination at 37 J/cm2 total dose

Calcipotriol assisted MAL-PDT

Luis A Torezan, MD

In topical photodynamic therapy (PDT) for non-melanoma skin cancers, a photosensitizing prodrug, 5-aminolaevulinic acid (ALA) or its methylated ester, methyl aminolevulinate (MAL), is converted to the endogenous photosensitizer protoporphyrinIX (PpIX).

Reduced response rates are observed in thicker skin lesions, which may be due to insufficient PpIX accumulation within the target tissue.

To enhance PpIX production,several physical and chemical pretreatments have been suggested. One of the chemical substances proposed to stimulate PpIX production is vitamin D because of its ability of being a keratinocyte pro-differentiating hormone.

Based on in vitro and in animal model studies, we propose to study the potential impact of patient vitamin D pre-treatment in AK response to MAL-PDT.

A randomized, controlled Split -scalp study with Calcipotriol Assisted MAL-PDT versus conventional MAL-PDT for actinic keratosis (AK) is proposed.

Twenty patients ( male gender only) with symmetrically distributed multiple AK lesions on the scalp will be included. Patients must have at least five AKs per field to be eligible.

After simple randomization, one half of the scalp will be treated with Calcipotriol ointment 50 mcg/g (Daivonex, Leo Pharma, Denmark) for 15 consecutive days.

After this period, the entire scalp will be submitted to topical PDT with Methylaminolevulinate 16% (Metvix, Galderma France) under occlusion for 90 minutes and then, illuminated with a light source consisting of a Light Emitting Diode device (LED) at 635 nm ( Aktilite - Photocure, Norway). The total light dose will be 37J/cm2.

Immediately before and after illumination with LED, measurements of the fluorescence intensity will be taken in 3 isolated spots in both sides of the scalp with a spectroscopy deviceUSB 2000+ ( Ocean Optics ® - Dunedin, Fl, USA).

AK lesions will be counted and mapped by a dermatologist not involved in the study before and after 3 months.

All patients will be advised to apply sunscreens 50 + 3x/day for the following 7 days after the procedure.

A 0-10 Visual Analogue Scale (VAS) will be used to measure the pain intensity during the illumination.

Records will be taken after 90 days and compared between sides: side effects, AK lesion response and pain level intensity. Also, a long term follow up will be provided at 6 and 12 months after.

Potential Impact of Patient Vitamin D Status in AK Response to MAL-PDT

Efficacy of Calcipotriol Assisted MAL-PDT Versus Conventional MAL-PDT for Actinic Keratosis: a Randomized and Controlled Study

To compare the efficacy of topical PDT alone versus Calcipotriol assisted PDT for AKs on the scalp.

The values in the data table represent the mean (+sd) number of lesions on each side at 3, 6 and 12 months post intervention.

Lesion counts include lesions that have not been cleared and also newly emerged lesions ( if new lesions emerge on the treated field) At baseline: number of AKs was 290 on the CAL-PDT side and 284 on the conventional side.

AK clearance after PDT and comparison between the sides The values in the data table represent the percentage of AK clearance on each side at 3, 6 and 12 months post intervention.

At baseline: 290 on the CAL-PDT side and 284 on the conventional side.

Measurement of pain during LED illumination and comparison between the sides with a visual analogue scale (VAS), considering 0 as absence of pain and 10 as the most severe pain.

At baseline, before the illumination, there is an absence of pain, which means Score 0 (zero) for all participants before the procedure.

Pain is reffered during and after the illumination and measured with the VAS scale, reported by each patient.

Measurement of PPIX fluorescence on both sides of the scalp before and immediately after LED illumination PpIX fluorescence was measured in three different spot areas on the scalp before and immediately after PDT on each side.

The measurements were taken noninvasively in the areas where PpIX fluorescence was more intense, with a handheld fluorescence photometer (USB 2000+ spectroscopy device; Ocean Optics, Dunedin, FL, U.S.A.). The photometer illuminates a circular skin area with a diameter of 1 cm with blue light (400-420 nm), matching the Soret band of PpIX at 405-420 nm. By measuring excitation wavelengths at 600- 700 nm, the corresponding red PpIX fluorescence intensity at 633 nm is detected. Measurements were taken in arbitrary units. The mean PpIX fluorescence value for each side was calculated before and after the treatment.

University of Sao Paulo

Assistant Professor of Dermatology

During light exposure patients were asked to evaluate the intensity of pain using a visual analogue scale (VAS), considering 0 as absence of pain and 10 as the most severe pain. Local skin reactions (erythema, edema, pustules, crusts, erosions and ulcerations) were recorded as well as any systemic adverse events during treatment and after follow-up visits. Clinical assessments of the local skin reactions were performed on a pre-defined scale as: 0 = no reaction, + mild, ++ moderate, +++ severe

Calcipotriol ointment 50 mcg/g applied once a day for 15 consecutive days in one half of the scalp, before Conventional topical PDT

Calcipotriol assisted MAL-PDT: Calcipotriol 50 mcg/g for 15 days prior to PDT. Curettage of lesions and application of MAl cream 16% for 90 minutes under occlusion followed by LED 635 nm illumination at 37 J/cm2 total dose

Calcipotriol Assisted MAL-PDT

Conventional topical PDT with Methylaminolevulinate 16% in one half of the scalp with multiple AKs.

Conventional MAL-PDT: Curettage of lesions and application of MAl cream 16% for 90 minutes under occlusion followed by LED 635 nm illumination at 37 J/cm2 total dose

Conventional topical PDT with Methylaminolevulinate 16% in one half of the scalp with multiple AKs.

Conventional MAL-PDT: Curettage of lesions and application of MAl cream 16% for 90 minutes under occlusion followed by LED 635 nm illumination at 37 J/cm2 total dose

Calcipotriol ointment 50 mcg/g applied once a day for 15 consecutive days in one half of the scalp, before Conventional topical PDT Calcipotriol assisted MAL-PDT: Calcipotriol 50 mcg/g for 15 days prior to PDT. Curettage of lesions and application of MAl cream 16% for 90 minutes under occlusion followed by LED 635 nm illumination at 37 J/cm2 total dose

All Participants

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

Brazil

Region of Enrollment

CAL-PDT side

Conventional PDT

CAL-PDT side grade I

CAL-PDT side grade II

Conventional PDT grade I

Conventional PDT grade II

AKs were clinically divided in 2 categories: grade I and grade II, based on Olsen et al classification. Grade I is a thinner lesion. Grade II is a thicker lesion. Both types co-exist on the same patient and reflects the skin photodamage.

number of AKs at baseline

20 male patients were selected and enrolled in the study. The eligibility criteria were: male sex, minimum age of 50 years old, at least 6 AKs symmetrically distributed on the scalp, only AKs grades I and II and immunocompetent patients. To receive either Conventional PDT or CAL-PDT on the allocated side of the scalp (right or left)

Dr Luis Torezan Associate Professor Dermatology

3 months outcome

6 months outcome

12 months outcome

Calcipotriol 15 days before - once a day intervention: MAL-PDT plus curettage Illumination LED 635 nm 37J/cm2

intervention: MAL-PDT plus curettage Illumination LED 635 nm 37J/cm2

Changes From Baseline in Actinic Keratosis - Lesion Base Count.

Percentage of Actinic Keratosis (AK) Lesions Cleared

Pain Scores Immediately Post Illumination

Student's t-test or the Mann-Whitney test was used according to the assumption of normality of data for PpIX fluorescence intensity

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Role of Calcipotriol as Radioprotector of Skin	NCT00445250	Radiodermatitis	Calcipotriol	18 Years - 75 Years	Rabin Medical Center
The Role of Calcipotriol as Radioprotector of Skin	NCT00445250	Radiodermatitis	Calcipotriol	18 Years - 75 Years	Rabin Medical Center
Potential Impact of Patient Vitamin D Status in AK Response to MAL-PDT	NCT02878382	Actinic Keratos...	Conventional MA... Calcipotriol as...	50 Years - 80 Years	University of Sao Paulo
The Role of Calcipotriol as Radioprotector of Skin	NCT00445250	Radiodermatitis	Calcipotriol	18 Years - 75 Years	Rabin Medical Center

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