Recruiting
Phase 2

Light Sensitive Cream

Sponsor:

The Center for Clinical and Cosmetic Research

Code:

NCT07931664

Conditions

Cutaneous Squamous Cell Carcinoma in Situ

Facial Cutaneous Squamous Cell Carcinoma in Situ

Cutaneous Squamous Cell Carcinoma

Upper Extremities/Trunk Cutaneous Squamous Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Aminolevulinic Acid 20% Topical Solution with Blue Light (dose 20 J/cm2)

Aminolevulinic Acid 20% Topical Solution with Blue Light (dose 10 J/cm2)

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, upper extremities and trunk, using a light sensitive cream 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 skin cancer section the treatment was able to remove, and;
  • seeing how many participants had no remaining affected skin cancer sections after treatment.

Participants who qualify will be asked to complete 12 visits in total and will receive a total of two treatments, after voluntarily consent has been given.

Conditions

Cutaneous Squamous Cell Carcinoma in Situ

Facial Cutaneous Squamous Cell Carcinoma in Situ

Cutaneous Squamous Cell Carcinoma

Upper Extremities/Trunk Cutaneous Squamous Cell Carcinoma

Study ID

NCT07931664

Start date

Nov 25, 2025

Status verified date

Nov, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Nov, 2026

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).
  • Voluntary written consent required.
  • Must have a recently diagnosed (no more than six months from first study visit) facial or trunk/ upper extremities isSCC (Squamous Cell Carcinoma in situ) lesion that meets surgery excision size requirements.
  • Cannot have other dermatological disease in the isSCC 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.
  • If female, cannot be pregnant before and during the study and agree to use acceptable forms of birth control.

Exclusion Criteria:

  • Sensitive to any of the study treatment ingredients.
  • Pregnant or lactating.
  • Medical laboratory evidence of other non-isSCC tumor in the target lesion biopsy specimen.
  • History of recurrence in the target isSCC lesion.
  • Medical laboratory evidence of certain 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.
  • History of abnormal heart muscles.
  • Currently participating in a research study or have been treated with an investigational product within 30 days from first study treatment.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Facial isSCC Photodynamic Therapy (Blue light dose 20 J/cm2)

8 participants will be enrolled to this arm.

experimental: Trunk and/or upper extremities isSCC Photodynamic Therapy (Blue light dose 20 J/cm2)

8 participants will be enrolled to this arm.

experimental: Facial isSCC Photodynamic Therapy (Blue light dose 10 J/cm2)

7 participants will be enrolled to this arm.

experimental: Trunk and/or upper extremities isSCC Photodynamic Therapy (Blue light dose 10 J/cm2)

7 participants will be enrolled to this arm.

Interventions

Aminolevulinic Acid 20% Topical Solution with Blue Light (dose 20 J/cm2)

Participants will have their isSCC lesions prepped then treated with Aminolevulinic Acid 20% Topical Solution (Levulan® Kerastick® Applicators) (ALA), followed by Blue Light therapy administered for 16 minutes and 40 seconds to deliver the total desired light dose to the isSCC lesion.

Aminolevulinic Acid 20% Topical Solution with Blue Light (dose 10 J/cm2)

Participants will have their isSCC lesions prepped then treated with Aminolevulinic Acid 20% Topical Solution (Levulan® Kerastick® Applicators) (ALA), followed by Blue Light therapy administered for 8 minutes and 20 seconds to deliver the total desired light dose to the isSCC lesion.

Primary outcome measure

  • Number of participants with Histological Clearance of treated isSCC lesion [ Time Frame: Up to 63 days after treatment 2. ]

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 Coordinator

305-933-6716info@centerforclinicalandcosmeticresearch.com

Principal Investigator:

Mark S. Nestor, MD, PhD

More Information

Sponsor

The Center for Clinical and Cosmetic Research

Last update posted

Nov 12, 2026

Last verified

Nov, 2026

Keywords

  • skin cancer
  • Squamous Cell Carcinoma
  • Squamous Cell Carcinoma in situ
  • Cutaneous Squamous Cell Carcinoma in situ
  • Facial Cutaneous Squamous Cell Carcinoma in situ
  • Facial skin cancer
  • Upper Extremities and Trunk skin cancer
  • Upper Extremities and Trunk Squamous Cell Carcinoma in situ

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-13. This information was provided to ClinicalTrials.gov by The Center for Clinical and Cosmetic Research on 2026-11-12. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.