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Hedgehog Pathway Inhibitor

Patidegib Gel 2% for Gorlin Syndrome

Phase 3

Recruiting

Research Sponsored by Sol-Gel Technologies, Ltd.

Eligibility Criteria Checklist

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

Must have

Key

Subject must be at least 18 years old at the Screening Visit

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 12

Awards & highlights

Study Summary

This trial aims to see if Patidegib Gel 2% can prevent new basal cell carcinomas (BCCs) on the face of adults with Gorlin syndrome. Participants will apply either

Who is the study for?

This trial is for adults over 18 with Gorlin Syndrome, who have had at least 15 basal cell carcinomas (BCCs) on the face in the past two years and currently have a minimum of 10 BCCs. Participants must not use other facial skin medications during the trial.Check my eligibility

What is being tested?

The study tests if Patidegib Gel 2% can prevent new BCCs on the face of Gorlin Syndrome patients compared to a Vehicle Gel without active drug. It's applied twice daily for one year, and results are measured after this period.See study design

What are the potential side effects?

While specific side effects aren't listed here, topical gels like Patidegib may cause skin irritation, redness, itching or swelling at the application site.

Eligibility Criteria

Inclusion Criteria

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

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I am at least 18 years old.

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My cancer has a PTCH1 mutation.

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I have had 15 or more basal cell carcinomas on my face in the last 2 years.

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I have at least 10 basal cell carcinomas on my face.

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I have at least 10 basal cell carcinomas on my face.

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I am willing to not use any facial skin products during the trial.

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My cancer has a positive PTCH1 mutation.

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I am at least 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 12 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 new BCCs on the face at Month 12

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Patidegib Gel 2%Experimental Treatment1 Intervention

Patidegib Gel 2% (w/w), applied topically to the face twice daily for 12 months

Group II: Vehicle GelPlacebo Group1 Intervention

Vehicle Gel, applied topically to the face twice daily for 12 months

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

Sol-Gel Technologies, Ltd.Lead Sponsor

13 Previous Clinical Trials

3,948 Total Patients Enrolled

Premier Research Group plcIndustry Sponsor

62 Previous Clinical Trials

69,235 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 new participants currently being accepted for enrollment in this ongoing medical study?

"Yes, the information available on clinicaltrials.gov confirms that this trial is actively recruiting participants. The study was initially posted on January 1st, 2024 and was most recently updated on January 30th, 2024. The trial aims to enroll a total of 140 patients across five different sites."

Answered by AI

What are the potential risks and hazards associated with the application of Patidegib Gel 2% in patients?

"The safety rating for Patidegib Gel 2% is determined to be a 3 by our team at Power. This score aligns with the Phase 3 trial status, indicating that there exists both efficacy data and multiple rounds of safety data supporting its use."

Answered by AI

At present, how many distinct locations are simultaneously conducting this experimental investigation?

"There are various locations participating in the patient recruitment for this trial. These include the Center for Dermatology Clinical Research in Fremont, Minnesota Clinical Study Center in New Brighton, and Apex Clinical Research Center in Mayfield Heights. Additionally, there are 5 other sites involved as well."

Answered by AI

What is the current number of individuals actively involved in this medical study?

"In order to successfully carry out this study, a total of 140 eligible participants are needed. Sol-Gel Technologies, Ltd., the sponsor of the trial, will be overseeing its execution from various sites such as the Center for Dermatology Clinical Research in Fremont, California and the Minnesota Clinical Study Center located in New Brighton, Minnesota."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Efficacy and Safety of Patidegib Gel 2% for Preventing Basal Cell Carcinomas on the Face of Adults With Gorlin Syndrome

2024. "Efficacy and Safety of Patidegib Gel 2% for Preventing Basal Cell Carcinomas on the Face of Adults With Gorlin Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06050122.