Clinical Trials Unit
Stanford University School of Medicine's Center for Advanced Dermatologic Investigation is the Dermatology Department's clinical trials unit.
The Center is home to 12-15 ongoing clinical studies, investigating the safety and efficacy of new and currently available drugs and over-the-counter medications. The Center works with Stanford's own panel on medical research, leading pharmaceutical companies,and the Food and Drug Administration to safely and ethically expand the medical field's knowledge of dermatologic treatments. New studies begin regularly, and the Center continues to recruit patients with skin aging, sun damage, skin cancer (including basal cell carcinomas), psoriasis, atopic dermatitis, rosacea, and other dermatologic diseases for ongoing studies.
Skin Aging Studies
We seek to understand the human aging processes as it relates to skin on a fundamental level. To this end, our studies focus on clinical and translational research efforts ranging from: (1) the analysis of gene changes which predispose individuals to exceptionally youthful skin to (2) molecular signatures that may be biomarkers for aging skin to (3) the careful study of new candidate agents which might affect the skin aging process.
Nonmelanoma Skin Cancer
Recent advances in our understanding of basal cell skin cancer biology have enabled the development of cutting edge study drugs which combat tumor growth. We are currently home to a number of clinical trials at the forefront of potential therapy for advanced or metastatic basal cell cancer. In addition, we seek to understand the biology of basal cell skin cancers and to identify molecular predictors for treatment success.
Acne Rosecea
This is a common and frustrating chronic inflammatory condition of the face, usually affecting older individuals. The causes of this complex condition are the subject of much study. Our clinical studies seek to identify new topical or oral medications to improve the symptoms of acne rosacea.
Contact
For more information, please email dermtrials@stanford.edu
Featured Clinical Trials
A Phase 3 Study to Evaluate the Efficacy and Safety of MGL-3196 (Resmetirom) in Patients With NASH and Fibrosis
A double-blind placebo controlled randomized Phase 3 study to determine if 80 or 100 mg of MGL-3196 as compared with placebo resolves NASH and/or reduces fibrosis on liver biopsy and prevents progression to cirrhosis and/or advanced liver disease
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: MGL-3196
- drug: Placebo
Eligibility
Inclusion Criteria:
1. Must be willing to participate in the study and provide written informed consent.
2. Male and female adults ≥ 18 years of age.
3. Suspected or confirmed diagnosis of NASH
1. Metabolic risk factors and AST > 20 U/L
2. Criteria consistent with liver fibrosis as defined as one of the following:
- Biochemical test for fibrosis OR
- Fibroscan test OR
- Historical liver biopsy with diagnosis of NASH with fibrosis Stage 2 or 3
4. MRI-PDFF with increased fat fraction
5. Biopsy-proven NASH (Baseline liver biopsy) based on a liver biopsy obtained within 24
weeks before anticipated date of randomization (if the biopsy is deemed acceptable for
interpretation by the central reader) with fibrosis stage 1A, 1B, 2, or 3 on liver
biopsy and NAS of ≥ 4 with a score of at least 1 in each of the following NAS
components:
1. Steatosis (scored 0 to 3)
2. Ballooning degeneration (scored 0 to 2)
3. Lobular inflammation (scored 0 to 3)
Exclusion Criteria:
1. History of significant alcohol consumption for a period of more than 3 consecutive
months within 1 year prior to Screening.
2. Regular use of drugs historically associated with NAFLD
3. History of bariatric surgery or intestinal bypass surgery within the 5 years prior to
randomization or planned during the conduct of the study.
4. Recent significant weight gain or loss
5. HbA1c ≥ 9.0%.
6. Glucagon-like peptide 1 [GLP-1] agonist, high dose Vitamin E (> 400 IU/day), or
pioglitazone therapy unless stable dose for 24 weeks prior to biopsy.
7. Presence of cirrhosis on liver biopsy defined as stage 4 fibrosis.
8. Diagnosis of hepatocellular carcinoma (HCC).
9. MELD score ≥12, as determined at Screening, unless due to therapeutic anti
coagulation.
10. Hepatic decompensation
11. Chronic liver diseases other than NASH
12. Active autoimmune disease
13. Serum ALT > 250 U/L.
14. Active, serious medical disease with a likely life expectancy < 2 years.
15. Participation in an investigational new drug trial in the 60 days or 5 half-lives,
whichever is longer.
16. Any other condition which, in the opinion of the Investigator, would impede
compliance, hinder completion of the study, compromise the well-being of the patient,
or interfere with the study outcomes.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Recruiting
Psoriasis Clinical Trials
A Phase 3 Study to Evaluate the Efficacy and Safety of MGL-3196 (Resmetirom) in Patients With NASH and Fibrosis
A double-blind placebo controlled randomized Phase 3 study to determine if 80 or 100 mg of MGL-3196 as compared with placebo resolves NASH and/or reduces fibrosis on liver biopsy and prevents progression to cirrhosis and/or advanced liver disease
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: MGL-3196
- drug: Placebo
Eligibility
Inclusion Criteria:
1. Must be willing to participate in the study and provide written informed consent.
2. Male and female adults ≥ 18 years of age.
3. Suspected or confirmed diagnosis of NASH
1. Metabolic risk factors and AST > 20 U/L
2. Criteria consistent with liver fibrosis as defined as one of the following:
- Biochemical test for fibrosis OR
- Fibroscan test OR
- Historical liver biopsy with diagnosis of NASH with fibrosis Stage 2 or 3
4. MRI-PDFF with increased fat fraction
5. Biopsy-proven NASH (Baseline liver biopsy) based on a liver biopsy obtained within 24
weeks before anticipated date of randomization (if the biopsy is deemed acceptable for
interpretation by the central reader) with fibrosis stage 1A, 1B, 2, or 3 on liver
biopsy and NAS of ≥ 4 with a score of at least 1 in each of the following NAS
components:
1. Steatosis (scored 0 to 3)
2. Ballooning degeneration (scored 0 to 2)
3. Lobular inflammation (scored 0 to 3)
Exclusion Criteria:
1. History of significant alcohol consumption for a period of more than 3 consecutive
months within 1 year prior to Screening.
2. Regular use of drugs historically associated with NAFLD
3. History of bariatric surgery or intestinal bypass surgery within the 5 years prior to
randomization or planned during the conduct of the study.
4. Recent significant weight gain or loss
5. HbA1c ≥ 9.0%.
6. Glucagon-like peptide 1 [GLP-1] agonist, high dose Vitamin E (> 400 IU/day), or
pioglitazone therapy unless stable dose for 24 weeks prior to biopsy.
7. Presence of cirrhosis on liver biopsy defined as stage 4 fibrosis.
8. Diagnosis of hepatocellular carcinoma (HCC).
9. MELD score ≥12, as determined at Screening, unless due to therapeutic anti
coagulation.
10. Hepatic decompensation
11. Chronic liver diseases other than NASH
12. Active autoimmune disease
13. Serum ALT > 250 U/L.
14. Active, serious medical disease with a likely life expectancy < 2 years.
15. Participation in an investigational new drug trial in the 60 days or 5 half-lives,
whichever is longer.
16. Any other condition which, in the opinion of the Investigator, would impede
compliance, hinder completion of the study, compromise the well-being of the patient,
or interfere with the study outcomes.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Recruiting
Dermatology Clinical Trials
A Phase 3 Study to Evaluate the Efficacy and Safety of MGL-3196 (Resmetirom) in Patients With NASH and Fibrosis
A double-blind placebo controlled randomized Phase 3 study to determine if 80 or 100 mg of MGL-3196 as compared with placebo resolves NASH and/or reduces fibrosis on liver biopsy and prevents progression to cirrhosis and/or advanced liver disease
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: MGL-3196
- drug: Placebo
Eligibility
Inclusion Criteria:
1. Must be willing to participate in the study and provide written informed consent.
2. Male and female adults ≥ 18 years of age.
3. Suspected or confirmed diagnosis of NASH
1. Metabolic risk factors and AST > 20 U/L
2. Criteria consistent with liver fibrosis as defined as one of the following:
- Biochemical test for fibrosis OR
- Fibroscan test OR
- Historical liver biopsy with diagnosis of NASH with fibrosis Stage 2 or 3
4. MRI-PDFF with increased fat fraction
5. Biopsy-proven NASH (Baseline liver biopsy) based on a liver biopsy obtained within 24
weeks before anticipated date of randomization (if the biopsy is deemed acceptable for
interpretation by the central reader) with fibrosis stage 1A, 1B, 2, or 3 on liver
biopsy and NAS of ≥ 4 with a score of at least 1 in each of the following NAS
components:
1. Steatosis (scored 0 to 3)
2. Ballooning degeneration (scored 0 to 2)
3. Lobular inflammation (scored 0 to 3)
Exclusion Criteria:
1. History of significant alcohol consumption for a period of more than 3 consecutive
months within 1 year prior to Screening.
2. Regular use of drugs historically associated with NAFLD
3. History of bariatric surgery or intestinal bypass surgery within the 5 years prior to
randomization or planned during the conduct of the study.
4. Recent significant weight gain or loss
5. HbA1c ≥ 9.0%.
6. Glucagon-like peptide 1 [GLP-1] agonist, high dose Vitamin E (> 400 IU/day), or
pioglitazone therapy unless stable dose for 24 weeks prior to biopsy.
7. Presence of cirrhosis on liver biopsy defined as stage 4 fibrosis.
8. Diagnosis of hepatocellular carcinoma (HCC).
9. MELD score ≥12, as determined at Screening, unless due to therapeutic anti
coagulation.
10. Hepatic decompensation
11. Chronic liver diseases other than NASH
12. Active autoimmune disease
13. Serum ALT > 250 U/L.
14. Active, serious medical disease with a likely life expectancy < 2 years.
15. Participation in an investigational new drug trial in the 60 days or 5 half-lives,
whichever is longer.
16. Any other condition which, in the opinion of the Investigator, would impede
compliance, hinder completion of the study, compromise the well-being of the patient,
or interfere with the study outcomes.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Recruiting
Pediatric Dermatology Clinical Trials
A Phase 3 Study to Evaluate the Efficacy and Safety of MGL-3196 (Resmetirom) in Patients With NASH and Fibrosis
A double-blind placebo controlled randomized Phase 3 study to determine if 80 or 100 mg of MGL-3196 as compared with placebo resolves NASH and/or reduces fibrosis on liver biopsy and prevents progression to cirrhosis and/or advanced liver disease
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: MGL-3196
- drug: Placebo
Eligibility
Inclusion Criteria:
1. Must be willing to participate in the study and provide written informed consent.
2. Male and female adults ≥ 18 years of age.
3. Suspected or confirmed diagnosis of NASH
1. Metabolic risk factors and AST > 20 U/L
2. Criteria consistent with liver fibrosis as defined as one of the following:
- Biochemical test for fibrosis OR
- Fibroscan test OR
- Historical liver biopsy with diagnosis of NASH with fibrosis Stage 2 or 3
4. MRI-PDFF with increased fat fraction
5. Biopsy-proven NASH (Baseline liver biopsy) based on a liver biopsy obtained within 24
weeks before anticipated date of randomization (if the biopsy is deemed acceptable for
interpretation by the central reader) with fibrosis stage 1A, 1B, 2, or 3 on liver
biopsy and NAS of ≥ 4 with a score of at least 1 in each of the following NAS
components:
1. Steatosis (scored 0 to 3)
2. Ballooning degeneration (scored 0 to 2)
3. Lobular inflammation (scored 0 to 3)
Exclusion Criteria:
1. History of significant alcohol consumption for a period of more than 3 consecutive
months within 1 year prior to Screening.
2. Regular use of drugs historically associated with NAFLD
3. History of bariatric surgery or intestinal bypass surgery within the 5 years prior to
randomization or planned during the conduct of the study.
4. Recent significant weight gain or loss
5. HbA1c ≥ 9.0%.
6. Glucagon-like peptide 1 [GLP-1] agonist, high dose Vitamin E (> 400 IU/day), or
pioglitazone therapy unless stable dose for 24 weeks prior to biopsy.
7. Presence of cirrhosis on liver biopsy defined as stage 4 fibrosis.
8. Diagnosis of hepatocellular carcinoma (HCC).
9. MELD score ≥12, as determined at Screening, unless due to therapeutic anti
coagulation.
10. Hepatic decompensation
11. Chronic liver diseases other than NASH
12. Active autoimmune disease
13. Serum ALT > 250 U/L.
14. Active, serious medical disease with a likely life expectancy < 2 years.
15. Participation in an investigational new drug trial in the 60 days or 5 half-lives,
whichever is longer.
16. Any other condition which, in the opinion of the Investigator, would impede
compliance, hinder completion of the study, compromise the well-being of the patient,
or interfere with the study outcomes.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Recruiting
A Phase 3 Study to Evaluate the Efficacy and Safety of MGL-3196 (Resmetirom) in Patients With NASH and Fibrosis
A double-blind placebo controlled randomized Phase 3 study to determine if 80 or 100 mg of MGL-3196 as compared with placebo resolves NASH and/or reduces fibrosis on liver biopsy and prevents progression to cirrhosis and/or advanced liver disease
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: MGL-3196
- drug: Placebo
Eligibility
Inclusion Criteria:
1. Must be willing to participate in the study and provide written informed consent.
2. Male and female adults ≥ 18 years of age.
3. Suspected or confirmed diagnosis of NASH
1. Metabolic risk factors and AST > 20 U/L
2. Criteria consistent with liver fibrosis as defined as one of the following:
- Biochemical test for fibrosis OR
- Fibroscan test OR
- Historical liver biopsy with diagnosis of NASH with fibrosis Stage 2 or 3
4. MRI-PDFF with increased fat fraction
5. Biopsy-proven NASH (Baseline liver biopsy) based on a liver biopsy obtained within 24
weeks before anticipated date of randomization (if the biopsy is deemed acceptable for
interpretation by the central reader) with fibrosis stage 1A, 1B, 2, or 3 on liver
biopsy and NAS of ≥ 4 with a score of at least 1 in each of the following NAS
components:
1. Steatosis (scored 0 to 3)
2. Ballooning degeneration (scored 0 to 2)
3. Lobular inflammation (scored 0 to 3)
Exclusion Criteria:
1. History of significant alcohol consumption for a period of more than 3 consecutive
months within 1 year prior to Screening.
2. Regular use of drugs historically associated with NAFLD
3. History of bariatric surgery or intestinal bypass surgery within the 5 years prior to
randomization or planned during the conduct of the study.
4. Recent significant weight gain or loss
5. HbA1c ≥ 9.0%.
6. Glucagon-like peptide 1 [GLP-1] agonist, high dose Vitamin E (> 400 IU/day), or
pioglitazone therapy unless stable dose for 24 weeks prior to biopsy.
7. Presence of cirrhosis on liver biopsy defined as stage 4 fibrosis.
8. Diagnosis of hepatocellular carcinoma (HCC).
9. MELD score ≥12, as determined at Screening, unless due to therapeutic anti
coagulation.
10. Hepatic decompensation
11. Chronic liver diseases other than NASH
12. Active autoimmune disease
13. Serum ALT > 250 U/L.
14. Active, serious medical disease with a likely life expectancy < 2 years.
15. Participation in an investigational new drug trial in the 60 days or 5 half-lives,
whichever is longer.
16. Any other condition which, in the opinion of the Investigator, would impede
compliance, hinder completion of the study, compromise the well-being of the patient,
or interfere with the study outcomes.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Recruiting
A Phase 3 Study to Evaluate the Efficacy and Safety of MGL-3196 (Resmetirom) in Patients With NASH and Fibrosis
A double-blind placebo controlled randomized Phase 3 study to determine if 80 or 100 mg of MGL-3196 as compared with placebo resolves NASH and/or reduces fibrosis on liver biopsy and prevents progression to cirrhosis and/or advanced liver disease
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: MGL-3196
- drug: Placebo
Eligibility
Inclusion Criteria:
1. Must be willing to participate in the study and provide written informed consent.
2. Male and female adults ≥ 18 years of age.
3. Suspected or confirmed diagnosis of NASH
1. Metabolic risk factors and AST > 20 U/L
2. Criteria consistent with liver fibrosis as defined as one of the following:
- Biochemical test for fibrosis OR
- Fibroscan test OR
- Historical liver biopsy with diagnosis of NASH with fibrosis Stage 2 or 3
4. MRI-PDFF with increased fat fraction
5. Biopsy-proven NASH (Baseline liver biopsy) based on a liver biopsy obtained within 24
weeks before anticipated date of randomization (if the biopsy is deemed acceptable for
interpretation by the central reader) with fibrosis stage 1A, 1B, 2, or 3 on liver
biopsy and NAS of ≥ 4 with a score of at least 1 in each of the following NAS
components:
1. Steatosis (scored 0 to 3)
2. Ballooning degeneration (scored 0 to 2)
3. Lobular inflammation (scored 0 to 3)
Exclusion Criteria:
1. History of significant alcohol consumption for a period of more than 3 consecutive
months within 1 year prior to Screening.
2. Regular use of drugs historically associated with NAFLD
3. History of bariatric surgery or intestinal bypass surgery within the 5 years prior to
randomization or planned during the conduct of the study.
4. Recent significant weight gain or loss
5. HbA1c ≥ 9.0%.
6. Glucagon-like peptide 1 [GLP-1] agonist, high dose Vitamin E (> 400 IU/day), or
pioglitazone therapy unless stable dose for 24 weeks prior to biopsy.
7. Presence of cirrhosis on liver biopsy defined as stage 4 fibrosis.
8. Diagnosis of hepatocellular carcinoma (HCC).
9. MELD score ≥12, as determined at Screening, unless due to therapeutic anti
coagulation.
10. Hepatic decompensation
11. Chronic liver diseases other than NASH
12. Active autoimmune disease
13. Serum ALT > 250 U/L.
14. Active, serious medical disease with a likely life expectancy < 2 years.
15. Participation in an investigational new drug trial in the 60 days or 5 half-lives,
whichever is longer.
16. Any other condition which, in the opinion of the Investigator, would impede
compliance, hinder completion of the study, compromise the well-being of the patient,
or interfere with the study outcomes.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Recruiting