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Photodynamic Therapy (Blue light dose 10 J/cm2 at 10 mW/cm2) for Squamous Cell Carcinoma

Phase 2

Recruiting

Led By Mark S Nestor, MD, PhD

Research Sponsored by The Center for Clinical and Cosmetic Research

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Cannot have other dermatological disease in the isSCC target area

If female, cannot be pregnant before and during the study and agree to use acceptable forms of birth control

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 16 weeks

Awards & highlights

Study Summary

This trial tests if a cream and light source can safely and effectively treat facial skin cancer. Participants receive 2 treatments over 12 visits.

Who is the study for?

Adults with a recent diagnosis of facial skin cancer (isSCC) that can be treated by surgery are eligible for this trial. Participants must not have other skin conditions in the affected area, agree to follow study rules, and women must not be pregnant or breastfeeding and use birth control.Check my eligibility

What is being tested?

The trial is testing a treatment involving a light-sensitive cream applied to the face followed by exposure to blue light. The aim is to see how well it removes early-stage cancer cells from the upper layer of facial skin over two treatments and 12 visits.See study design

What are the potential side effects?

Potential side effects may include reactions at the application site due to sensitivity to ingredients in the cream or light therapy, such as redness, swelling, or discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My skin cancer area does not have any other skin conditions.

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I am not pregnant and agree to use birth control during the study.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 16 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 16 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 16 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants with Histological Clearance of treated isSCC lesion

Secondary outcome measures

Local Skin Response Scale

Number of participants with clinical clearance of treated isSCC lesion

Side effects data

From 2019 Phase 4 trial • 30 Patients • NCT02075671

10%

Contact Dermatitis

10%

Post-Treatment Erythema

10%

Hyperpigmentation

100%

80%

60%

40%

20%

Study treatment Arm

Levulan and Blu-U Light

Vehicle and Blu-U Light

Vehicle Only

Trial Design

1Treatment groups

Experimental Treatment

Group I: Photodynamic Therapy (Blue light dose 10 J/cm2 at 10 mW/cm2)Experimental Treatment1 Intervention

20 participants will be enrolled to this arm

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Center for Clinical and Cosmetic ResearchLead Sponsor

6 Previous Clinical Trials

285 Total Patients Enrolled

Sun Pharmaceutical Industries LimitedIndustry Sponsor

64 Previous Clinical Trials

13,491 Total Patients Enrolled

Mark S Nestor, MD, PhDPrincipal InvestigatorCenter for Clinical and Cosmetic Research

1 Previous Clinical Trials

20 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open vacancies to participate in this clinical trial?

"Affirmative. Clinicaltrials.gov confirms that this research project, which initially launched on August 8th 2023, is still looking for participants. Currently the study requires 20 patients to be recruited from one medical facility."

Answered by AI

What is the size and scope of involvement in this experiment?

"Affirmative. According to clinicaltrials.gov, the investigation is currently recruiting as it was posted on August 8th 2023 and recently modified on November 28th 2023. The research requires a total of twenty participants from one medical centre."

Answered by AI

Is the application of Photodynamic Therapy (Blue light dose 10 J/cm2 at 10 mW/cm2) in compliance with FDA directives?

"Our team at Power estimates the safety of Photodynamic Therapy to be a 2, as it is currently being evaluated in Phase 2 clinical trials. Although there is data that indicates its security, no evidence exists yet for its efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluating the Use of Photodynamic Therapy to Treat Facial Cutaneous Squamous Cell Carcinoma in Situ (isSCC)

Mark Steven Nestor, M.D., Ph.D. 2023. "Evaluating the Use of Photodynamic Therapy to Treat Facial Cutaneous Squamous Cell Carcinoma in Situ (isSCC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06159842.

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