A Phase 2 interventional study of Aminolevulinic Acid 20% Topical Solution with Blue Light (dose 20 J/cm2) and Aminolevulinic Acid 20% Topical Solution with Blue Light (dose 10 J/cm2) in Cutaneous Squamous Cell Carcinoma in Situ, Facial Cutaneous Squamous Cell Carcinoma in Situ and Cutaneous Squamous Cell Carcinoma, sponsored by The Center for Clinical and Cosmetic Research. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by The Center for Clinical and Cosmetic Research · Phase 2, Interventional, and Treatment
Among 380 studies in Skin Neoplasms with a site in United States — 63 open to participants now, 97 under way, 7 of them phase 3. Skin Neoplasms · United States.
Among the 380 studies in Skin Neoplasms with a site in United States, this one is the 170th largest by planned enrollment of the 289 interventional ones that give a count, is one of 21 that started in 2025, is one of 83 in phase 2, reaches primary completion later than 23 of the 95 other live ones, and was the 365th registered.
605 studies on the registry are indexed under Skin Neoplasms; 127 are open to participants now.
Browse Skin Neoplasms studies →63 of the 380 studies in Skin Neoplasms with a site in United States are open now. Recruiting first, the newest first:
Vanderbilt-Ingram Cancer Center · Sites in United States
Ages 18+
Rutgers, The State University of New Jersey · Sites in United States
Ages 13+ · Healthy volunteers
University of Utah · Sites in United States
Ages 18–29 · Healthy volunteers
Marissa Lobl · Sites in United States
Ages 18+
Dana-Farber Cancer Institute · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 105 Skin Neoplasms studies recruiting now, 85 (81%) set no upper age limit and 9 (9%) stop at 75 or younger; 15 take children under 18; 25 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
380 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 84 · Phase 2 115 · Phase 3 26 · Phase 4 11
First in 1977; this study’s year is marked. 21 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 30 is below the median of 55 across 409 interventional studies indexed under Skin Neoplasms.
Median enrollment 43 across the 289 interventional studies, 149 across the 80 observational. Of the 258 that completed or were terminated, 92 (36%) have results posted.
This tab as a report to print or save as PDF → With an account.
107 of 380 have an industry lead sponsor. The 10 most frequent:
The Center for Clinical and Cosmetic Research is the lead sponsor of 10 studies on the registry; 3 are open to participants now.
The Center for Clinical and Cosmetic Research has 3 studies filed under Skin Neoplasms — fewer than ten, so there is no comparison to draw.
34 of the studies in Skin Neoplasms with a site in United States that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05608291Phase 3Regeneron PharmaceuticalsA Trial to See if the Combination of Fianlimab With Cemiplimab Works Better Than Pembrolizumab for Preventing or Delaying Melanoma From Coming Back After it Has Been Removed With Surgery | 2027-01-15 |
| NCT06947928Phase 3TuHURA Biosciences, Inc.Placebo-Controlled Trial of IFx-Hu2.0 Followed By Pembrolizumab In Checkpoint Inhibitor Naïve Participants With Advanced Or Metastatic Merkel Cell Carcinoma | 2027-03-31 |
| NCT05634252Phase 3University of UtahUndergraduate Skin Cancer Prevention Trial | 2027-09-04 |
| NCT07931664The Center for Clinical and Cosmetic ResearchEvaluating Photodynamic Therapy Used to Treat Cutaneous Squamous Cell Carcinoma in Situ (isSCC) on the Face, Upper Extremities & Trunk. | 2026-11 |
| NCT07201376Dartmouth-Hitchcock Medical CenterAssessment of Skin Lesions Using a Tissue Oxygen Imager Based on Protoporphyrin IX (PPIX) Fluorescence. This is an Open-label, Non-randomized, Feasibility Study That Includes a One-time Application of an FDA Approved Medication Followed by Local Imaging for Benign Skin Growth and Lesions Clinically | 2026-11 |
Add all 34 to your calendar (.ics) → With an account.
Among the 380 studies in Skin Neoplasms with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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:
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.
In the study, participants will be asked to complete the following:
To qualify for this trial, participants must:
All surgery samples collected from the participants towards the end of the study will be sent to a laboratory for testing.
All photographs of the treatment area collected during the study will be used as study data.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
8 participants will be enrolled to this arm.
Combination Product: Aminolevulinic Acid 20% Topical Solution with Blue Light (dose 20 J/cm2)
8 participants will be enrolled to this arm.
Combination Product: Aminolevulinic Acid 20% Topical Solution with Blue Light (dose 20 J/cm2)
7 participants will be enrolled to this arm.
Combination Product: Aminolevulinic Acid 20% Topical Solution with Blue Light (dose 10 J/cm2)
7 participants will be enrolled to this arm.
Combination Product: Aminolevulinic Acid 20% Topical Solution with Blue Light (dose 10 J/cm2)
Drug page: Aminolevulinic Acid
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.
Also known as: Levulan® Kerastick®, BLU-U® Blue Light Photodynamic Therapy Illuminator
Drug page: Aminolevulinic Acid
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.
Also known as: Levulan® Kerastick®, BLU-U® Blue Light Photodynamic Therapy Illuminator
Number of participants with Histological Clearance of treated isSCC lesion
Histological clearance is defined as the absence of detectable evidence of isSCC tumor cell nests by the central pathology reports
Time frame: Up to 63 days after treatment 2.
Number of participants with clinical clearance of treated isSCC lesion
Complete Clinical Clearance will be measured by the Investigator and is defined as when there is no clinically visible lesion remaining at the site.
Time frame: Up to 63 days after treatment 2.
Local Skin Response Scale
Observations and changes noted in the aesthetic appearance of the treated isSCC lesion site.
Time frame: Up to 63 days after treatment 2
Started Nov 2025 (actual). Primary completion is estimated for Nov 2026, 12 months after the start.
Of 35 phase 2 interventional studies under Skin Neoplasms, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 35 and three quarters within 97. This study's planned 12 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Aminolevulinic Acid
The Center for Clinical and Cosmetic Research