Recruiting
Phase 2

Light-Sensitive Gel

Sponsor:

The Center for Clinical and Cosmetic Research

Code:

NCT06577311

Conditions

Cutaneous Squamous Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Aminolevulinic acid hydrochloride 10% topical gel with Red Light

Study Details

Brief summary:

The goal of this clinical trial is to test how safe and effective it is to treat early form of cancer cells found in the upper skin layer of the face, using a light-sensitive gel used in combination with a light source.

The main questions this trial aims to answer are:

  • to confirm using laboratory testing, how much of the affected facial skin cancer section the treatment was able to remove, and;
  • seeing how many participants had no remaining affected facial skin cancer sections after treatment.

Participants who qualify will be asked to complete 14 visits in total and will receive a total of two treatments, after voluntarily consent has been given.

Conditions

Cutaneous Squamous Cell Carcinoma

Study ID

NCT06577311

Start date

Aug 14, 2024

Status verified date

Aug, 2024

Completion date

Aug, 2025

Anticipated

Primary completion date

Aug, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Must be an adult (18 years of age or older)
  • Must have a recently diagnosed (no more than six months from first study visit) facial SCCis lesion that meets surgery excision size requirements
  • Cannot have other dermatological disease in the SCCis target area
  • Must be willing to follow study instructions and complete study requirements, including not using non-approved lotions and creams on the treatments areas
  • Voluntary written consent required
  • Allow photographs of the area of skin cancer being treated on the face
  • Agree to use acceptable forms of birth control. If female, cannot be pregnant before and during the study

Exclusion Criteria:

  • Pregnant or lactating
  • Sensitive to any of the study treatment ingredients
  • Medical laboratory evidence of other non-SCCis tumor in the target lesion biopsy specimen
  • History of recurrence if the target SCCis lesion
  • Evidence of dermatological disease or skin condition in the treatment area
  • Medical laboratory evidence of growth patterns in the target lesion biopsy specimen
  • Chronic medical condition that in the Investigators opinion will interfere in the trial or affect participant safety.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Photodynamic Therapy (using Red light dose)

20 participants will be enrolled to this arm

Interventions

Aminolevulinic acid hydrochloride 10% topical gel with Red Light

Participants will have their facial Cutaneous Squamous Cell Carcinoma in situ (SCCis) prepped then treated with Aminolevulinic acid hydrochloride 10% topical gel (Ameluz ®), followed by red light therapy administered for 13 minutes and 30 seconds to deliver the total desired light dose to the SCCis lesion.

Primary outcome measure

  • Number of participants with histological clearance of treated SCCis lesion. [ Time Frame: an average of 12 weeks ]

Central Contacts and Locations

Central contacts

Clinical Coordinator

305-933-6716info@centerforclinicalandcosmeticresearch.com

Locations

Center for Clinical and Cosmetic Research

Recruiting

Aventura, Florida, United States, 33180

Contacts

Clinical Research Coordinator

305-933-6716info@centerforclinicalandcosmeticresearch.com

Mark S. Nestor, MD, PhD

305-933-6716nestormd@admcorp.com

Principal Investigator:

Mark S Nestor, M.D., Ph.D.

More Information

Sponsor

The Center for Clinical and Cosmetic Research

Last update posted

Aug 29, 2024

Last verified

Aug, 2024

Keywords

  • skin cancer
  • facial skin cancer
  • Squamous Cell Carcinoma
  • Squamous Cell Carcinoma in Situ
  • Cutaneous Squamous Cell Carcinoma in Situ
  • Facial Cutaneous Squamous Cell Carcinoma in Situ
  • SCCis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The Center for Clinical and Cosmetic Research on 2024-08-29.