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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.

This Study is to Evaluate the Safety and Pharmacokinetics of SBS-101 in Patients With Oral Premalignant Lesions

Clinicaltrials.gov identifier NCT03939364

Recruitment Status Not yet recruiting

First Posted May 6, 2019

Last update posted May 8, 2020

Study Description

Brief summary:

This study will be the first study investigating the safety, pharmacokinetics (PK), and efficacy of SBS-101 on oral pre-malignant lesions. As such, no clinical data has yet been generated using SBS-101 oral adhesive film.

  • Condition or Disease:Leukoplakia, Oral
  • Intervention/Treatment: Drug: SBS-101
    Drug: Placebo
  • Phase: Phase 1
Detailed Description


Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 24 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Other
  • Official Title: A Phase 1, Randomized, Double-blind, Placebo Controlled, Dose Escalation Study to Evaluate the Safety and Pharmacokinetics of SBS-101 After Intraoral Application in Patients With Oral Premalignant Lesions (OPL)
  • Estimated Study Start Date: October 2020
  • Estimated Primary Completion Date: April 2021
  • Estimated Study Completion Date: April 2021
Arms and interventions
Arm Intervention/treatment
Experimental: 0.1% SBS-101
Drug: SBS-101
Isotretinoin Oral-Adhesive Film
Experimental: 0.2% SBS-101
Drug: SBS-101
Isotretinoin Oral-Adhesive Film
Experimental: 0.3% SBS-101
Drug: SBS-101
Isotretinoin Oral-Adhesive Film
Placebo Comparator: Placebo
Drug: Placebo
Outcome Measures
  • Primary Outcome Measures: 1. The percentages of patients reporting any treatment-emergent adverse event (AE) will be tabulated by system organ class and preferred term for each treatment [ Time Frame: 13 weeks ]
  • 2. Percentages of patients with overall response will be summarized by treatment [ Time Frame: 13 weeks ]
    Overall response is defined as complete or partial response in either clinical or histological outcome without worsening of either.
  • Secondary Outcome Measures: 1. Plasma concentrations of isotretinoin will be summarized by treatment using descriptive statistics [ Time Frame: 13 weeks ]
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patient is able to comprehend and willing to sign an Informed Consent Form.

2. Patient is willing and able to follow all study instructions and to attend all study

3. Patient is male or female aged 18 years or older at Screening.

4. Patient has oral leukoplakia or erythroplakia at least 5mm in length on its longest
axis with histopathology showing mild, moderate, or severe dysplasia (index lesion
histology score of ≥2) with incisional (punch) biopsy at Screening (or within 30 days
prior to Screening).

5. Patient agrees to not use any topical therapies (i.e. use of over the counter and
medically prescribed topical creams, ointments, or oral rinses) on the index lesion
other than the study drug that, in the Investigator's opinion, might influence the
status of the index lesion for the duration of the study.

6. Patient agrees to not apply any other topical products or use potential irritants
(i.e. alcohol containing mouthwash) to the oral premalignant lesions throughout the
study. Note: mouthwash that includes non-alcohol containing formulations of Listerine
and Crest is acceptable to use during the study.

7. If female, patient is non-pregnant, non-lactating and is not planning for pregnancy
during the study period or for 1 month after the last dose of study drug.

8. Female patients of non-childbearing potential must meet the following requirements:

1. Pre-menopausal with documentation of surgical sterilization (i.e., hysterectomy,
bilateral tubal ligation, bilateral oophorectomy, or bilateral salpingectomy) at
least 3 months prior to study entry.

2. Post-menopausal defined as amenorrhea for at least 12 months following cessation
of all exogenous hormonal treatments and with follicle-stimulating hormone (FSH)
level ≥40 milli-international units per milliliter (mIU/mL) at Screening.

9. Female patients of child-bearing potential must select and commit to use 2 forms of
effective contraception simultaneously, at least 1 of which must be a primary form,
unless absolute abstinence is the chosen method, or the patient has undergone a
hysterectomy. Patients must use 2 forms of effective contraception at least 1 month
prior to study initiation (Screening), during the study, and for 1 month after the
final dose of study drug.

Primary (hormonal or surgical)

1. Tubal ligation

2. Partner's vasectomy

3. Intrauterine devices

4. Birth control pills

5. Injectable/implantable/insertable hormonal birth control products Secondary
(Barrier Method)

1. Diaphragm (with spermicide)

2. Cervical cap (with spermicide)

3. Male condom (with spermicide)

10. Male patients must agree to use condoms during sexual intercourse during the study and
for 3 months after the final dose of study drug. If a female partner is of
childbearing potential, she should use contraception as detailed in Inclusion

# 9. Males must also agree to not donate sperm from the time of first dosing and for 3
months after the final dose of study drug.

11. Patient's Eastern Cooperative Oncology Group (ECOG) performance status grade is 0 or 1
at Screening.

12. Patient's organ function is determined to be adequate based on laboratory testing at
Screening (e.g. Hemoglobin levels ≥ 10g/dl; White Blood Cells (WBC) ≥ 3,000/μL;
Platelets ≥ 100,000/μL; Total bilirubin ≤ 1.5x Upper Limit of Normal (ULN); Aspartate
Aminotransferase (AST)/ Alanine aminotransferase (ALT) < 2x Upper Limit of Normal (ULN);, Blood urea nitrogen (BUN) & serum creatinine ≤ 1.5x Upper Limit of Normal (ULN); Lactate dehydrogenase (LDH) ≤ 1.5x Upper Limit of Normal (ULN); Glucose < 200 mg/dL; Thyroid Stimulating Hormone (TSH) ≤ 5.0 μU/mL; C-Reactive Protein 25,000 USP units per day) or
has previously used isotretinoin for the treatment of another condition within 6
months of Screening.

8. Patient is currently taking phenytoin or other prohibited medication

9. Patient's index lesion is a recurrent dysplastic lesion in a previously treated area
for oral cancer (previous treatment, bed/excision, etc.).

10. The patient has received radiation or chemoradiation therapy to oral cavity within 2
years of Randomization.

11. The patient has any immune compromising conditions at Screening (i.e. HIV, SLE, etc.)
or has been treated with immunomodulating medications within 6 months of Screening.

12. Patient currently has poorly controlled diabetes mellitus (uninterrupted hemoglobin
A1c >9% for ≥1 year despite standard care).

13. Patient has a history of cardiac, hepatic (ALT and or AST >2x ULN, Total bilirubin
>1.5x ULN at Visit 1), or renal disease (eGFR<45 ml/min/1.73 m2) that, in the opinion of the Investigator, might put the patient at undue risk by participating in the study or interferes with the study drug application or the study assessments. 14. Patient has a history of sensitivity to any of the active ingredients in the study drug (e.g. isotretinoin, propylene glycol, natural mint), or retinoids, or vitamin A. 15. Patient has used oral isotretinoin within 14 days of Screening. Patients must agree to abstain from using oral isotretinoin throughout the duration in the study. 16. Patient has participated in an investigational drug trial in which administration of an investigational study drug occurred within 30 days prior to Randomization. 17. Patient is, in the opinion of the Investigator, not an appropriate candidate for study participation.

Contacts and Locations

Contact: Ashley Pleasants +1 434 989 2851 Ashley.Pleasants@synteract.com


United States, Alabama
University of Alabama at Birmingham (UAB) - The Kirklin Clinic (TKC)

United States, Massachusetts
Brigham and Women's Hospital

United States, North Carolina
Carolinas Center for Oral Health

United States, Pennsylvania
PennState Health Milton S. Hershey Medical Center

United States, Texas
University of Texas Southwestern Medical Center - Oral & Maxillofacial Surgery Clinic

Sponsors and Collaborators

Skyline Biosciences


Study Director: Joy Schleyer Skyline Biosciences

More Information
  • Responsible Party: Skyline Biosciences
  • ClinicalTrials.gov Identifier: NCT03939364 History of Changes
  • Other Study ID Numbers: SBS-101-CL-001
  • First Posted: May 6, 2019 Key Record Dates
  • Last Update Posted: May 8, 2020
  • Last Verified: May 2020
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Skyline Biosciences: Erythroplakia, oral Erythro-leukoplakia, oral
  • Additional relevant MeSH terms: Precancerous Conditions
    Leukoplakia, Oral