A Phase 1 interventional study of Cutaneous Cream application and Placebo Cutaneous Cream application in Cutaneous Squamous Cell Carcinoma in Situ (CSCCis), sponsored by Novartis Pharmaceuticals. Terminated at 8 sites in 3 countries. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2020-12-11.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 1, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 45 studies in Carcinoma in Situ with a site in United States — 11 open to participants now, 13 under way, 4 of them phase 3. Carcinoma in Situ · United States.
Among the 45 studies in Carcinoma in Situ with a site in United States, this one is the 20th largest by enrollment of the 40 interventional ones that give a count, is one of 6 that started in 2017, is one of 13 in phase 1, and was the 26th registered.
78 studies on the registry are indexed under Carcinoma in Situ; 22 are open to participants now.
Browse Carcinoma in Situ studies →11 of the 45 studies in Carcinoma in Situ with a site in United States are open now. Recruiting first, the newest first:
Protara Therapeutics · Sites in United States, Ukraine
Ages 18+
Michael A. O'Donnell · Sites in United States
Ages 18–99
Merck Sharp & Dohme LLC · Sites in United States, Argentina, Australia and 16 more countries
Ages 18+
Ferring Pharmaceuticals · Sites in United States, Canada, Czechia and 5 more countries
Ages 18+
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) · Sites in United States
Ages 20–89 · Women only
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 18 Carcinoma in Situ studies recruiting now, 11 (61%) set no upper age limit and 4 (22%) stop at 75 or younger; 2 take children under 18; 1 takes healthy volunteers.
This study: 18 Years to 90 Years · 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.
45 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 17 · Phase 2 15 · Phase 3 11
First in 1993; this study’s year is marked. 6 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 40 is below the median of 80 across 62 interventional studies indexed under Carcinoma in Situ.
Median enrollment 39 across the 40 interventional studies, 300 across the 5 observational. Of the 29 that completed or were terminated, 10 (34%) have results posted.
This tab as a report to print or save as PDF → With an account.
23 of 45 have an industry lead sponsor. The 10 most frequent:
This study is registered under Novartis Pharmaceuticals, one of the names counted as Novartis. Under that name alone:
Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
Novartis has 1 study filed under Carcinoma in Situ — fewer than ten, so there is no comparison to draw.
2 of the studies in Carcinoma in Situ with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06115486Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)EXERT-BCH Exercise Regimen to Improve Muscle Mass After Treatment of Breast Cancer | 2027-01 |
| NCT05865028Elizabeth J FranzmannA Proof of Concept Trial Investigating Safety and Efficacy of APG-157 in Oral Dysplasia | 2027-05-24 |
Add all 2 to your calendar (.ics) → With an account.
Among the 45 studies in Carcinoma in Situ with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
The purpose of this first in human and proof of concept study is to characterize the safety, tolerability and initial efficacy of CLL442 in patients with Squamous Cell Carcinoma in situ (SCCis) to enable further clinical development of CLL442.
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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 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.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
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.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Cutaneous Cream application twice daily
Drug: Cutaneous Cream application
Placebo Cutaneous Cream application twice daily
Drug: Placebo Cutaneous Cream application
Cutaneous Cream application twice daily with experimental (CLL442)
Cutaneous Cream application twice daily with placebo
Incidence of adverse events (AE), serious adverse events (SAEs) of CLL442 on lesion free skin at Day 7
As part of safety and tolerability assessment, assess the incidence of adverse events (AE), serious adverse events (SAEs) in patients with SCCis treated with CLL442 or placebo on lesion free skin for 7 days
Time frame: Day 7
Change in the size of One SCCis lesion area at Day 84 from Day 1
Area is measured by pen and ruler and standardized digital photography
Time frame: Day 1 and Day 84
Change in the Local skin reactions severity score at Day 7 or Day 84 from Day 1
Local skin reactions severity score
Time frame: Day 1, Day 7, Day 84
Incidence of adverse events (AE), serious adverse events (SAEs) of CLL442 on SCCis lesion at Day 84
As part of safety and tolerability assessment, assess the incidence of adverse events (AE), serious adverse events (SAEs) in patients with SCCis treated with CLL442 or placebo on SCCis lesion area for 84 days.
Time frame: Day 84
CLL442 plasma concentration
To evaluate the systemic pharmacokinetics of CLL442
Time frame: Day 1 through Day 84
Time required to achieve 50% decrease in 1 lesion area.
Part of efficacy assessment.
Time frame: 84 days
Time required to achieve complete SCCis 1 lesion clearance (censored by end of study visit).
Part of efficacy assessment.
Time frame: 84 days
Percentage of pts with complete clearance at the end of the study, assessed visually and histologically
Part of efficacy assessment.
Time frame: 84 days
Plan to share: Undecided — Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Ran from Dec 2017 to primary completion in Nov 2018, 10 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.