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
Once-Nightly Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy
The purpose of this study is to determine whether once-nightly FT218 is safe and effective for the treatment of excessive daytime sleepiness and cataplexy in subjects with narcolepsy.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Placebo
- drug: FT218
Eligibility
Inclusion Criteria:
1. Male or female subjects 16 years of age or older
2. Willing and able to give written informed consent for study participation. For young
adults (16 and 17 years old) who have not reached the age of majority they must be
capable of giving assent and consent from a legally authorized guardian must be
obtained, as required by local laws and regulations
3. Documented evidence of a diagnosis of NT1 (type 1 narcolepsy) or NT2 (type 2
narcolepsy) as, in part, determined by an overnight PSG (polysomnography) and next-day
MSLT (maintenance of sleep latency test) with 2 or more SOREMPs (sleep onset REM) with
mean sleep latency in the pathological range i.e. < 8 minutes and meeting the NT1 and
NT2 as defined by the International Classification of Sleep Disorders -3 criteria.
4. Current continuing presence of EDS (excessive daytime sleepiness) as defined by
subject report for the last 3 months and an ESS (Epworth sleepiness scale) > 10
5. For NT1 only, current continuing presence of cataplexy as defined by subject report
for the last 3 months
6. Subjects may use concomitant stimulants, but must comply with the following:
1. They must be on a stable dose of stimulants for at least 3 weeks prior to
starting the screening process for this study; AND
2. They must use the same stimulant regimen throughout the entire study period,
including during screening and posttreatment periods
3. They must discontinue all anti cataplexy drugs
7. Addition inclusion criteria per protocol
Exclusion criteria
1. Any prior use of sodium oxybate is allowed in the study but within the following
exclusions:
1. Previous dosing must have been limited to no more than 4.5g per night
2. Patient should not have taken sodium oxybate for more than 2 weeks.
3. All previous dosing must not have occurred within the last year prior to entry to
the study.
2. Current use of sodium valproate
3. Any use of the following prohibited medications for the duration of the clinical
study:
1. Anticonvulsants
2. Clonidine
3. SSRIs (selective serotonin re-uptake inhibitors) and serotonin and norepinephrine
re-uptake inhibitors (SNRIs)
4. MAOIs (monoamine oxidase inhibitors)
5. TCAs (tricyclic antidepressants)
6. Hypnotics
7. Anxiolytics
8. Sedating antihistamines
9. Antipsychotics
10. Other experimental medications designed to treat narcolepsy, cataplexy or any
other condition
4. Treatment with any investigational products within 3 months before study enrollment
5. Any drug known to affect sleep-wake function. Concomitant stimulant use is permitted
6. Additional exclusion criteria per protocol
Ages Eligible for Study
16 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
Clete Kushida
I'm interested
Psoriasis Clinical Trials
Once-Nightly Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy
The purpose of this study is to determine whether once-nightly FT218 is safe and effective for the treatment of excessive daytime sleepiness and cataplexy in subjects with narcolepsy.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Placebo
- drug: FT218
Eligibility
Inclusion Criteria:
1. Male or female subjects 16 years of age or older
2. Willing and able to give written informed consent for study participation. For young
adults (16 and 17 years old) who have not reached the age of majority they must be
capable of giving assent and consent from a legally authorized guardian must be
obtained, as required by local laws and regulations
3. Documented evidence of a diagnosis of NT1 (type 1 narcolepsy) or NT2 (type 2
narcolepsy) as, in part, determined by an overnight PSG (polysomnography) and next-day
MSLT (maintenance of sleep latency test) with 2 or more SOREMPs (sleep onset REM) with
mean sleep latency in the pathological range i.e. < 8 minutes and meeting the NT1 and
NT2 as defined by the International Classification of Sleep Disorders -3 criteria.
4. Current continuing presence of EDS (excessive daytime sleepiness) as defined by
subject report for the last 3 months and an ESS (Epworth sleepiness scale) > 10
5. For NT1 only, current continuing presence of cataplexy as defined by subject report
for the last 3 months
6. Subjects may use concomitant stimulants, but must comply with the following:
1. They must be on a stable dose of stimulants for at least 3 weeks prior to
starting the screening process for this study; AND
2. They must use the same stimulant regimen throughout the entire study period,
including during screening and posttreatment periods
3. They must discontinue all anti cataplexy drugs
7. Addition inclusion criteria per protocol
Exclusion criteria
1. Any prior use of sodium oxybate is allowed in the study but within the following
exclusions:
1. Previous dosing must have been limited to no more than 4.5g per night
2. Patient should not have taken sodium oxybate for more than 2 weeks.
3. All previous dosing must not have occurred within the last year prior to entry to
the study.
2. Current use of sodium valproate
3. Any use of the following prohibited medications for the duration of the clinical
study:
1. Anticonvulsants
2. Clonidine
3. SSRIs (selective serotonin re-uptake inhibitors) and serotonin and norepinephrine
re-uptake inhibitors (SNRIs)
4. MAOIs (monoamine oxidase inhibitors)
5. TCAs (tricyclic antidepressants)
6. Hypnotics
7. Anxiolytics
8. Sedating antihistamines
9. Antipsychotics
10. Other experimental medications designed to treat narcolepsy, cataplexy or any
other condition
4. Treatment with any investigational products within 3 months before study enrollment
5. Any drug known to affect sleep-wake function. Concomitant stimulant use is permitted
6. Additional exclusion criteria per protocol
Ages Eligible for Study
16 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
Clete Kushida
I'm interested
Dermatology Clinical Trials
Once-Nightly Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy
The purpose of this study is to determine whether once-nightly FT218 is safe and effective for the treatment of excessive daytime sleepiness and cataplexy in subjects with narcolepsy.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Placebo
- drug: FT218
Eligibility
Inclusion Criteria:
1. Male or female subjects 16 years of age or older
2. Willing and able to give written informed consent for study participation. For young
adults (16 and 17 years old) who have not reached the age of majority they must be
capable of giving assent and consent from a legally authorized guardian must be
obtained, as required by local laws and regulations
3. Documented evidence of a diagnosis of NT1 (type 1 narcolepsy) or NT2 (type 2
narcolepsy) as, in part, determined by an overnight PSG (polysomnography) and next-day
MSLT (maintenance of sleep latency test) with 2 or more SOREMPs (sleep onset REM) with
mean sleep latency in the pathological range i.e. < 8 minutes and meeting the NT1 and
NT2 as defined by the International Classification of Sleep Disorders -3 criteria.
4. Current continuing presence of EDS (excessive daytime sleepiness) as defined by
subject report for the last 3 months and an ESS (Epworth sleepiness scale) > 10
5. For NT1 only, current continuing presence of cataplexy as defined by subject report
for the last 3 months
6. Subjects may use concomitant stimulants, but must comply with the following:
1. They must be on a stable dose of stimulants for at least 3 weeks prior to
starting the screening process for this study; AND
2. They must use the same stimulant regimen throughout the entire study period,
including during screening and posttreatment periods
3. They must discontinue all anti cataplexy drugs
7. Addition inclusion criteria per protocol
Exclusion criteria
1. Any prior use of sodium oxybate is allowed in the study but within the following
exclusions:
1. Previous dosing must have been limited to no more than 4.5g per night
2. Patient should not have taken sodium oxybate for more than 2 weeks.
3. All previous dosing must not have occurred within the last year prior to entry to
the study.
2. Current use of sodium valproate
3. Any use of the following prohibited medications for the duration of the clinical
study:
1. Anticonvulsants
2. Clonidine
3. SSRIs (selective serotonin re-uptake inhibitors) and serotonin and norepinephrine
re-uptake inhibitors (SNRIs)
4. MAOIs (monoamine oxidase inhibitors)
5. TCAs (tricyclic antidepressants)
6. Hypnotics
7. Anxiolytics
8. Sedating antihistamines
9. Antipsychotics
10. Other experimental medications designed to treat narcolepsy, cataplexy or any
other condition
4. Treatment with any investigational products within 3 months before study enrollment
5. Any drug known to affect sleep-wake function. Concomitant stimulant use is permitted
6. Additional exclusion criteria per protocol
Ages Eligible for Study
16 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
Clete Kushida
I'm interested
Pediatric Dermatology Clinical Trials
Once-Nightly Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy
The purpose of this study is to determine whether once-nightly FT218 is safe and effective for the treatment of excessive daytime sleepiness and cataplexy in subjects with narcolepsy.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Placebo
- drug: FT218
Eligibility
Inclusion Criteria:
1. Male or female subjects 16 years of age or older
2. Willing and able to give written informed consent for study participation. For young
adults (16 and 17 years old) who have not reached the age of majority they must be
capable of giving assent and consent from a legally authorized guardian must be
obtained, as required by local laws and regulations
3. Documented evidence of a diagnosis of NT1 (type 1 narcolepsy) or NT2 (type 2
narcolepsy) as, in part, determined by an overnight PSG (polysomnography) and next-day
MSLT (maintenance of sleep latency test) with 2 or more SOREMPs (sleep onset REM) with
mean sleep latency in the pathological range i.e. < 8 minutes and meeting the NT1 and
NT2 as defined by the International Classification of Sleep Disorders -3 criteria.
4. Current continuing presence of EDS (excessive daytime sleepiness) as defined by
subject report for the last 3 months and an ESS (Epworth sleepiness scale) > 10
5. For NT1 only, current continuing presence of cataplexy as defined by subject report
for the last 3 months
6. Subjects may use concomitant stimulants, but must comply with the following:
1. They must be on a stable dose of stimulants for at least 3 weeks prior to
starting the screening process for this study; AND
2. They must use the same stimulant regimen throughout the entire study period,
including during screening and posttreatment periods
3. They must discontinue all anti cataplexy drugs
7. Addition inclusion criteria per protocol
Exclusion criteria
1. Any prior use of sodium oxybate is allowed in the study but within the following
exclusions:
1. Previous dosing must have been limited to no more than 4.5g per night
2. Patient should not have taken sodium oxybate for more than 2 weeks.
3. All previous dosing must not have occurred within the last year prior to entry to
the study.
2. Current use of sodium valproate
3. Any use of the following prohibited medications for the duration of the clinical
study:
1. Anticonvulsants
2. Clonidine
3. SSRIs (selective serotonin re-uptake inhibitors) and serotonin and norepinephrine
re-uptake inhibitors (SNRIs)
4. MAOIs (monoamine oxidase inhibitors)
5. TCAs (tricyclic antidepressants)
6. Hypnotics
7. Anxiolytics
8. Sedating antihistamines
9. Antipsychotics
10. Other experimental medications designed to treat narcolepsy, cataplexy or any
other condition
4. Treatment with any investigational products within 3 months before study enrollment
5. Any drug known to affect sleep-wake function. Concomitant stimulant use is permitted
6. Additional exclusion criteria per protocol
Ages Eligible for Study
16 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
Clete Kushida
I'm interested
Once-Nightly Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy
The purpose of this study is to determine whether once-nightly FT218 is safe and effective for the treatment of excessive daytime sleepiness and cataplexy in subjects with narcolepsy.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Placebo
- drug: FT218
Eligibility
Inclusion Criteria:
1. Male or female subjects 16 years of age or older
2. Willing and able to give written informed consent for study participation. For young
adults (16 and 17 years old) who have not reached the age of majority they must be
capable of giving assent and consent from a legally authorized guardian must be
obtained, as required by local laws and regulations
3. Documented evidence of a diagnosis of NT1 (type 1 narcolepsy) or NT2 (type 2
narcolepsy) as, in part, determined by an overnight PSG (polysomnography) and next-day
MSLT (maintenance of sleep latency test) with 2 or more SOREMPs (sleep onset REM) with
mean sleep latency in the pathological range i.e. < 8 minutes and meeting the NT1 and
NT2 as defined by the International Classification of Sleep Disorders -3 criteria.
4. Current continuing presence of EDS (excessive daytime sleepiness) as defined by
subject report for the last 3 months and an ESS (Epworth sleepiness scale) > 10
5. For NT1 only, current continuing presence of cataplexy as defined by subject report
for the last 3 months
6. Subjects may use concomitant stimulants, but must comply with the following:
1. They must be on a stable dose of stimulants for at least 3 weeks prior to
starting the screening process for this study; AND
2. They must use the same stimulant regimen throughout the entire study period,
including during screening and posttreatment periods
3. They must discontinue all anti cataplexy drugs
7. Addition inclusion criteria per protocol
Exclusion criteria
1. Any prior use of sodium oxybate is allowed in the study but within the following
exclusions:
1. Previous dosing must have been limited to no more than 4.5g per night
2. Patient should not have taken sodium oxybate for more than 2 weeks.
3. All previous dosing must not have occurred within the last year prior to entry to
the study.
2. Current use of sodium valproate
3. Any use of the following prohibited medications for the duration of the clinical
study:
1. Anticonvulsants
2. Clonidine
3. SSRIs (selective serotonin re-uptake inhibitors) and serotonin and norepinephrine
re-uptake inhibitors (SNRIs)
4. MAOIs (monoamine oxidase inhibitors)
5. TCAs (tricyclic antidepressants)
6. Hypnotics
7. Anxiolytics
8. Sedating antihistamines
9. Antipsychotics
10. Other experimental medications designed to treat narcolepsy, cataplexy or any
other condition
4. Treatment with any investigational products within 3 months before study enrollment
5. Any drug known to affect sleep-wake function. Concomitant stimulant use is permitted
6. Additional exclusion criteria per protocol
Ages Eligible for Study
16 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
Clete Kushida
I'm interested
Once-Nightly Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy
The purpose of this study is to determine whether once-nightly FT218 is safe and effective for the treatment of excessive daytime sleepiness and cataplexy in subjects with narcolepsy.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Placebo
- drug: FT218
Eligibility
Inclusion Criteria:
1. Male or female subjects 16 years of age or older
2. Willing and able to give written informed consent for study participation. For young
adults (16 and 17 years old) who have not reached the age of majority they must be
capable of giving assent and consent from a legally authorized guardian must be
obtained, as required by local laws and regulations
3. Documented evidence of a diagnosis of NT1 (type 1 narcolepsy) or NT2 (type 2
narcolepsy) as, in part, determined by an overnight PSG (polysomnography) and next-day
MSLT (maintenance of sleep latency test) with 2 or more SOREMPs (sleep onset REM) with
mean sleep latency in the pathological range i.e. < 8 minutes and meeting the NT1 and
NT2 as defined by the International Classification of Sleep Disorders -3 criteria.
4. Current continuing presence of EDS (excessive daytime sleepiness) as defined by
subject report for the last 3 months and an ESS (Epworth sleepiness scale) > 10
5. For NT1 only, current continuing presence of cataplexy as defined by subject report
for the last 3 months
6. Subjects may use concomitant stimulants, but must comply with the following:
1. They must be on a stable dose of stimulants for at least 3 weeks prior to
starting the screening process for this study; AND
2. They must use the same stimulant regimen throughout the entire study period,
including during screening and posttreatment periods
3. They must discontinue all anti cataplexy drugs
7. Addition inclusion criteria per protocol
Exclusion criteria
1. Any prior use of sodium oxybate is allowed in the study but within the following
exclusions:
1. Previous dosing must have been limited to no more than 4.5g per night
2. Patient should not have taken sodium oxybate for more than 2 weeks.
3. All previous dosing must not have occurred within the last year prior to entry to
the study.
2. Current use of sodium valproate
3. Any use of the following prohibited medications for the duration of the clinical
study:
1. Anticonvulsants
2. Clonidine
3. SSRIs (selective serotonin re-uptake inhibitors) and serotonin and norepinephrine
re-uptake inhibitors (SNRIs)
4. MAOIs (monoamine oxidase inhibitors)
5. TCAs (tricyclic antidepressants)
6. Hypnotics
7. Anxiolytics
8. Sedating antihistamines
9. Antipsychotics
10. Other experimental medications designed to treat narcolepsy, cataplexy or any
other condition
4. Treatment with any investigational products within 3 months before study enrollment
5. Any drug known to affect sleep-wake function. Concomitant stimulant use is permitted
6. Additional exclusion criteria per protocol
Ages Eligible for Study
16 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
Clete Kushida
I'm interested