Vitamin D Supplementation as a Neoadjuvant for Photodynamic Therapy of Actinic Keratoses

NCT04140292 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: CASE5619
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

This study is open to individuals with Actinic Keratoses (skin lesions that have the potential to turn into skin cancer), who are receiving photodynamic therapy (PDT) as part of their clinical care. The purpose of this study is to test and demonstrate that vitamin D pre-treatment can enhance PDT efficacy in the treatment of Actinic Keratoses. Participants will be asked to take vitamin D supplements prior to their standard of care PDT treatment. Participation in the research will last about 3-4 months.

Conditions

Actinic Keratosis

Outcome Measures

Primary Outcomes (1)

• Clinical PDT Response as Measured by Percent Change in AK Lesions From Baseline to 3 Months

  Clinical PDT response as measured by the percent change of AK lesions 3 months after treatment Baseline vitamin D (calcidiol) level will be taken for each patient.

  3 months after treatment

Secondary Outcomes (4)

• Correlation Between Vitamin D Receptor (VDR) Polymorphisms and Percent Reduction in AK

  3 months after treatment

• Number of Participants Reporting 1 or Higher on the Pain Scale

  During treatment (at the 5 min mark), and again immediately afterwards.

• Tolerability as Measured by Participants' Symptom Score Sheets

  1 week after treatment

• Accumulation of Protoporphyrin IX (PpIX) Within AK

  3 months after treatment

Study Arms (1)

Vitamin D3 + Photodynamic therapy (PDT)

EXPERIMENTAL

Patients receive Vitamin D3 10,000 IU daily for 5 or 14 days depending on VitD baseline level. They then undergo Photodynamic therapy (PDT) for treatment of actinic keratosis.

Drug: Photodynamic therapy (PDT); Drug: Vitamin D3

Interventions

Photodynamic therapy (PDT) DRUG

PDT is a technique that combines a photosensitizing drug and an intense light source to kill tumor cells Noninvasive fluorescence dosimetry may be performed on up to 6 lesions. Levulan Kerastick will be applied to each lesion and left to incubate for 30 minutes. Blue light (Blu-U device, 20 J/cm2, 33 minutes) will be administered.

Vitamin D3 + Photodynamic therapy (PDT)

Vitamin D3 DRUG

D3 pills (10,000 IU each) to be taken daily at home, beginning at either day -5 or day -14, as per their assignment Participants will receive a 5-day or 14-day supplementation of Vitamin D10,000 IU depending on their baseline Vitamin D 25 Hydroxy result

Vitamin D3 + Photodynamic therapy (PDT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Actinic keratoses in sufficient numbers (\>10) to warrant PDT therapy in the clinic
• Able to understand and willing to sign a written informed consent document
• Female subjects must not become pregnant during the study:
• The effects of 5-aminolevulinic acid (LevulanTM) on the human fetus are unknown. For this reason, women of child-bearing potential must agree to use contraception (double barrier method of birth control or abstinence) prior to study entry, and throughout study participation. Should a woman become pregnant or suspect that she is pregnant while she is participating in this study, she should inform the treating physician immediately.

You may not qualify if:

• Pregnant or nursing.
• At risk for hypercalcemia (renal disease, sarcoidosis, etc.)
• Using topical retinoids, since these can exacerbate the post-PDT erythema reaction.
• Using any topical treatment on their AKs; must stop at least one month prior.
• Currently undergoing treatment for other cancers with medical or radiation therapy.
• Patients with a known hypersensitivity to 5-aminolevulinic acid or any component of the study material.
• Patients with history of a photosensitivity disease, such as porphyria cutanea tarda.
• Currently participating in another clinical trial.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• Bullock TA, Negrey J, Hu B, Warren CB, Hasan T, Maytin EV. Significant improvement of facial actinic keratoses after blue light photodynamic therapy with oral vitamin D pretreatment: An interventional cohort-controlled trial. J Am Acad Dermatol. 2022 Jul;87(1):80-86. doi: 10.1016/j.jaad.2022.02.067. Epub 2022 Mar 18.

  PMID: 35314199 DERIVED

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Photochemotherapy; Cholecalciferol

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Results Point of Contact

• Title: Maytin, Edward, V
• Organization: Cleveland Clinic Foundation

taussigresearch@ccf.org

1-866-223-8100

Study Officials

• Edward V Maytin, MD, PhD

  Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Study group will be compared to a baseline cohort of patients from a previous study (IRB 16-1615) who received the same regimen of PDT, but without any Vit D

Study Record Dates

• First Submitted: October 24, 2019
• First Posted: October 25, 2019
• Study Start: January 13, 2020
• Primary Completion: November 24, 2020
• Study Completion: May 27, 2021
• Last Updated: June 24, 2022
• Results First Posted: June 24, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)