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
Efficacy and Safety Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis
This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study of the efficacy and safety of apremilast (CC-10004) in pediatric subjects with moderate to severe plaque psoriasis.
At least 230 pediatric subjects (ages 6 through 17 years) will be randomized 2:1 to receive either apremilast or placebo for the first 16 weeks and then all subjects will receive apremilast during the 36 week Extension Phase for a total of 52 weeks. Randomization to apremilast arm or placebo arm will be stratified by age group (6 to 11 years or 12 to 17 years). Subjects will receive apremilast treatment of either 20 mg twice daily (BID) or 30 mg BID, depending on weight. This Phase 3 study is being conducted to evaluate the safety and efficacy of apremilast in the treatment of pediatric subjects.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Apremilast (CC-10004)
- other: Placebo
Eligibility
Inclusion Criteria:
1. Males or female subjects 6 to 17 years of age, inclusive, at the time the informed
consent form is signed by the legal guardian
2. Subjects must have a weight of ≥ 20 kg
3. Diagnosis of chronic plaque psoriasis for at least 6 months prior to Screening.
4. Has moderate to severe plaque psoriasis at Screening and Baseline as defined by:
- PASI score ≥ 12; and
- Body surface area (BSA) ≥ 10%; and
- sPGA ≥ 3 (moderate to severe)
5. Disease inadequately controlled by or inappropriate for topical therapy for psoriasis
6. Candidate for systemic therapy or phototherapy
Exclusion Criteria:
1. Guttate, erythrodermic, or pustular psoriasis at Screening and Baseline
2. Psoriasis flare or rebound within 4 weeks prior to Screening
3. Prior history of suicide attempt at any time in the subject's lifetime prior to
Screening or randomization in the study, or major psychiatric illness requiring
hospitalization within 3 years prior to signing the assent and informed consent
4. Answer "Yes" to any question on the Columbia-Suicide Severity Rating Scale during
Screening or at Baseline
5. Current or planned concurrent use of the following therapies that may have a possible
effect on psoriasis
a. Topical therapy within 2 weeks prior to randomization (including but not limited to
topical corticosteroids, topical retinoid or vitamin D analog preparations,
tacrolimus, pimecrolimus, or anthralin/dithranol)
Exceptions*:
i. Low potency or weak corticosteroids (please refer to the Investigators' Manual)
will be allowed as background therapy for treatment of the face, axillae and groin in
accordance with manufacturer's suggested usage ii. Unmedicated skin moisturizer (eg,
Eucerin®) will also be permitted for body lesions
*Subjects should not use these topical treatments within 24 hours prior to the clinic
visit.
b. Conventional systemic therapy for psoriasis within 4 weeks prior to randomization
c. Phototherapy treatment (ie, ultraviolet B [UVB], PUVA) within 4 weeks prior to
randomization d. Biologic therapy within 4 weeks prior to randomization or 5 PK/PD
half-lives (whichever is longer).
Ages Eligible for Study
6 Years - 17 Years
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Research Team @ Pediatric Dermatology
650-724-1982
Not Recruiting
Psoriasis Clinical Trials
Efficacy and Safety Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis
This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study of the efficacy and safety of apremilast (CC-10004) in pediatric subjects with moderate to severe plaque psoriasis.
At least 230 pediatric subjects (ages 6 through 17 years) will be randomized 2:1 to receive either apremilast or placebo for the first 16 weeks and then all subjects will receive apremilast during the 36 week Extension Phase for a total of 52 weeks. Randomization to apremilast arm or placebo arm will be stratified by age group (6 to 11 years or 12 to 17 years). Subjects will receive apremilast treatment of either 20 mg twice daily (BID) or 30 mg BID, depending on weight. This Phase 3 study is being conducted to evaluate the safety and efficacy of apremilast in the treatment of pediatric subjects.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Apremilast (CC-10004)
- other: Placebo
Eligibility
Inclusion Criteria:
1. Males or female subjects 6 to 17 years of age, inclusive, at the time the informed
consent form is signed by the legal guardian
2. Subjects must have a weight of ≥ 20 kg
3. Diagnosis of chronic plaque psoriasis for at least 6 months prior to Screening.
4. Has moderate to severe plaque psoriasis at Screening and Baseline as defined by:
- PASI score ≥ 12; and
- Body surface area (BSA) ≥ 10%; and
- sPGA ≥ 3 (moderate to severe)
5. Disease inadequately controlled by or inappropriate for topical therapy for psoriasis
6. Candidate for systemic therapy or phototherapy
Exclusion Criteria:
1. Guttate, erythrodermic, or pustular psoriasis at Screening and Baseline
2. Psoriasis flare or rebound within 4 weeks prior to Screening
3. Prior history of suicide attempt at any time in the subject's lifetime prior to
Screening or randomization in the study, or major psychiatric illness requiring
hospitalization within 3 years prior to signing the assent and informed consent
4. Answer "Yes" to any question on the Columbia-Suicide Severity Rating Scale during
Screening or at Baseline
5. Current or planned concurrent use of the following therapies that may have a possible
effect on psoriasis
a. Topical therapy within 2 weeks prior to randomization (including but not limited to
topical corticosteroids, topical retinoid or vitamin D analog preparations,
tacrolimus, pimecrolimus, or anthralin/dithranol)
Exceptions*:
i. Low potency or weak corticosteroids (please refer to the Investigators' Manual)
will be allowed as background therapy for treatment of the face, axillae and groin in
accordance with manufacturer's suggested usage ii. Unmedicated skin moisturizer (eg,
Eucerin®) will also be permitted for body lesions
*Subjects should not use these topical treatments within 24 hours prior to the clinic
visit.
b. Conventional systemic therapy for psoriasis within 4 weeks prior to randomization
c. Phototherapy treatment (ie, ultraviolet B [UVB], PUVA) within 4 weeks prior to
randomization d. Biologic therapy within 4 weeks prior to randomization or 5 PK/PD
half-lives (whichever is longer).
Ages Eligible for Study
6 Years - 17 Years
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Research Team @ Pediatric Dermatology
650-724-1982
Not Recruiting
Dermatology Clinical Trials
Efficacy and Safety Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis
This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study of the efficacy and safety of apremilast (CC-10004) in pediatric subjects with moderate to severe plaque psoriasis.
At least 230 pediatric subjects (ages 6 through 17 years) will be randomized 2:1 to receive either apremilast or placebo for the first 16 weeks and then all subjects will receive apremilast during the 36 week Extension Phase for a total of 52 weeks. Randomization to apremilast arm or placebo arm will be stratified by age group (6 to 11 years or 12 to 17 years). Subjects will receive apremilast treatment of either 20 mg twice daily (BID) or 30 mg BID, depending on weight. This Phase 3 study is being conducted to evaluate the safety and efficacy of apremilast in the treatment of pediatric subjects.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Apremilast (CC-10004)
- other: Placebo
Eligibility
Inclusion Criteria:
1. Males or female subjects 6 to 17 years of age, inclusive, at the time the informed
consent form is signed by the legal guardian
2. Subjects must have a weight of ≥ 20 kg
3. Diagnosis of chronic plaque psoriasis for at least 6 months prior to Screening.
4. Has moderate to severe plaque psoriasis at Screening and Baseline as defined by:
- PASI score ≥ 12; and
- Body surface area (BSA) ≥ 10%; and
- sPGA ≥ 3 (moderate to severe)
5. Disease inadequately controlled by or inappropriate for topical therapy for psoriasis
6. Candidate for systemic therapy or phototherapy
Exclusion Criteria:
1. Guttate, erythrodermic, or pustular psoriasis at Screening and Baseline
2. Psoriasis flare or rebound within 4 weeks prior to Screening
3. Prior history of suicide attempt at any time in the subject's lifetime prior to
Screening or randomization in the study, or major psychiatric illness requiring
hospitalization within 3 years prior to signing the assent and informed consent
4. Answer "Yes" to any question on the Columbia-Suicide Severity Rating Scale during
Screening or at Baseline
5. Current or planned concurrent use of the following therapies that may have a possible
effect on psoriasis
a. Topical therapy within 2 weeks prior to randomization (including but not limited to
topical corticosteroids, topical retinoid or vitamin D analog preparations,
tacrolimus, pimecrolimus, or anthralin/dithranol)
Exceptions*:
i. Low potency or weak corticosteroids (please refer to the Investigators' Manual)
will be allowed as background therapy for treatment of the face, axillae and groin in
accordance with manufacturer's suggested usage ii. Unmedicated skin moisturizer (eg,
Eucerin®) will also be permitted for body lesions
*Subjects should not use these topical treatments within 24 hours prior to the clinic
visit.
b. Conventional systemic therapy for psoriasis within 4 weeks prior to randomization
c. Phototherapy treatment (ie, ultraviolet B [UVB], PUVA) within 4 weeks prior to
randomization d. Biologic therapy within 4 weeks prior to randomization or 5 PK/PD
half-lives (whichever is longer).
Ages Eligible for Study
6 Years - 17 Years
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Research Team @ Pediatric Dermatology
650-724-1982
Not Recruiting
Pediatric Dermatology Clinical Trials
Efficacy and Safety Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis
This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study of the efficacy and safety of apremilast (CC-10004) in pediatric subjects with moderate to severe plaque psoriasis.
At least 230 pediatric subjects (ages 6 through 17 years) will be randomized 2:1 to receive either apremilast or placebo for the first 16 weeks and then all subjects will receive apremilast during the 36 week Extension Phase for a total of 52 weeks. Randomization to apremilast arm or placebo arm will be stratified by age group (6 to 11 years or 12 to 17 years). Subjects will receive apremilast treatment of either 20 mg twice daily (BID) or 30 mg BID, depending on weight. This Phase 3 study is being conducted to evaluate the safety and efficacy of apremilast in the treatment of pediatric subjects.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Apremilast (CC-10004)
- other: Placebo
Eligibility
Inclusion Criteria:
1. Males or female subjects 6 to 17 years of age, inclusive, at the time the informed
consent form is signed by the legal guardian
2. Subjects must have a weight of ≥ 20 kg
3. Diagnosis of chronic plaque psoriasis for at least 6 months prior to Screening.
4. Has moderate to severe plaque psoriasis at Screening and Baseline as defined by:
- PASI score ≥ 12; and
- Body surface area (BSA) ≥ 10%; and
- sPGA ≥ 3 (moderate to severe)
5. Disease inadequately controlled by or inappropriate for topical therapy for psoriasis
6. Candidate for systemic therapy or phototherapy
Exclusion Criteria:
1. Guttate, erythrodermic, or pustular psoriasis at Screening and Baseline
2. Psoriasis flare or rebound within 4 weeks prior to Screening
3. Prior history of suicide attempt at any time in the subject's lifetime prior to
Screening or randomization in the study, or major psychiatric illness requiring
hospitalization within 3 years prior to signing the assent and informed consent
4. Answer "Yes" to any question on the Columbia-Suicide Severity Rating Scale during
Screening or at Baseline
5. Current or planned concurrent use of the following therapies that may have a possible
effect on psoriasis
a. Topical therapy within 2 weeks prior to randomization (including but not limited to
topical corticosteroids, topical retinoid or vitamin D analog preparations,
tacrolimus, pimecrolimus, or anthralin/dithranol)
Exceptions*:
i. Low potency or weak corticosteroids (please refer to the Investigators' Manual)
will be allowed as background therapy for treatment of the face, axillae and groin in
accordance with manufacturer's suggested usage ii. Unmedicated skin moisturizer (eg,
Eucerin®) will also be permitted for body lesions
*Subjects should not use these topical treatments within 24 hours prior to the clinic
visit.
b. Conventional systemic therapy for psoriasis within 4 weeks prior to randomization
c. Phototherapy treatment (ie, ultraviolet B [UVB], PUVA) within 4 weeks prior to
randomization d. Biologic therapy within 4 weeks prior to randomization or 5 PK/PD
half-lives (whichever is longer).
Ages Eligible for Study
6 Years - 17 Years
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Research Team @ Pediatric Dermatology
650-724-1982
Not Recruiting
Efficacy and Safety Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis
This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study of the efficacy and safety of apremilast (CC-10004) in pediatric subjects with moderate to severe plaque psoriasis.
At least 230 pediatric subjects (ages 6 through 17 years) will be randomized 2:1 to receive either apremilast or placebo for the first 16 weeks and then all subjects will receive apremilast during the 36 week Extension Phase for a total of 52 weeks. Randomization to apremilast arm or placebo arm will be stratified by age group (6 to 11 years or 12 to 17 years). Subjects will receive apremilast treatment of either 20 mg twice daily (BID) or 30 mg BID, depending on weight. This Phase 3 study is being conducted to evaluate the safety and efficacy of apremilast in the treatment of pediatric subjects.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Apremilast (CC-10004)
- other: Placebo
Eligibility
Inclusion Criteria:
1. Males or female subjects 6 to 17 years of age, inclusive, at the time the informed
consent form is signed by the legal guardian
2. Subjects must have a weight of ≥ 20 kg
3. Diagnosis of chronic plaque psoriasis for at least 6 months prior to Screening.
4. Has moderate to severe plaque psoriasis at Screening and Baseline as defined by:
- PASI score ≥ 12; and
- Body surface area (BSA) ≥ 10%; and
- sPGA ≥ 3 (moderate to severe)
5. Disease inadequately controlled by or inappropriate for topical therapy for psoriasis
6. Candidate for systemic therapy or phototherapy
Exclusion Criteria:
1. Guttate, erythrodermic, or pustular psoriasis at Screening and Baseline
2. Psoriasis flare or rebound within 4 weeks prior to Screening
3. Prior history of suicide attempt at any time in the subject's lifetime prior to
Screening or randomization in the study, or major psychiatric illness requiring
hospitalization within 3 years prior to signing the assent and informed consent
4. Answer "Yes" to any question on the Columbia-Suicide Severity Rating Scale during
Screening or at Baseline
5. Current or planned concurrent use of the following therapies that may have a possible
effect on psoriasis
a. Topical therapy within 2 weeks prior to randomization (including but not limited to
topical corticosteroids, topical retinoid or vitamin D analog preparations,
tacrolimus, pimecrolimus, or anthralin/dithranol)
Exceptions*:
i. Low potency or weak corticosteroids (please refer to the Investigators' Manual)
will be allowed as background therapy for treatment of the face, axillae and groin in
accordance with manufacturer's suggested usage ii. Unmedicated skin moisturizer (eg,
Eucerin®) will also be permitted for body lesions
*Subjects should not use these topical treatments within 24 hours prior to the clinic
visit.
b. Conventional systemic therapy for psoriasis within 4 weeks prior to randomization
c. Phototherapy treatment (ie, ultraviolet B [UVB], PUVA) within 4 weeks prior to
randomization d. Biologic therapy within 4 weeks prior to randomization or 5 PK/PD
half-lives (whichever is longer).
Ages Eligible for Study
6 Years - 17 Years
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Research Team @ Pediatric Dermatology
650-724-1982
Not Recruiting
Efficacy and Safety Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis
This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study of the efficacy and safety of apremilast (CC-10004) in pediatric subjects with moderate to severe plaque psoriasis.
At least 230 pediatric subjects (ages 6 through 17 years) will be randomized 2:1 to receive either apremilast or placebo for the first 16 weeks and then all subjects will receive apremilast during the 36 week Extension Phase for a total of 52 weeks. Randomization to apremilast arm or placebo arm will be stratified by age group (6 to 11 years or 12 to 17 years). Subjects will receive apremilast treatment of either 20 mg twice daily (BID) or 30 mg BID, depending on weight. This Phase 3 study is being conducted to evaluate the safety and efficacy of apremilast in the treatment of pediatric subjects.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Apremilast (CC-10004)
- other: Placebo
Eligibility
Inclusion Criteria:
1. Males or female subjects 6 to 17 years of age, inclusive, at the time the informed
consent form is signed by the legal guardian
2. Subjects must have a weight of ≥ 20 kg
3. Diagnosis of chronic plaque psoriasis for at least 6 months prior to Screening.
4. Has moderate to severe plaque psoriasis at Screening and Baseline as defined by:
- PASI score ≥ 12; and
- Body surface area (BSA) ≥ 10%; and
- sPGA ≥ 3 (moderate to severe)
5. Disease inadequately controlled by or inappropriate for topical therapy for psoriasis
6. Candidate for systemic therapy or phototherapy
Exclusion Criteria:
1. Guttate, erythrodermic, or pustular psoriasis at Screening and Baseline
2. Psoriasis flare or rebound within 4 weeks prior to Screening
3. Prior history of suicide attempt at any time in the subject's lifetime prior to
Screening or randomization in the study, or major psychiatric illness requiring
hospitalization within 3 years prior to signing the assent and informed consent
4. Answer "Yes" to any question on the Columbia-Suicide Severity Rating Scale during
Screening or at Baseline
5. Current or planned concurrent use of the following therapies that may have a possible
effect on psoriasis
a. Topical therapy within 2 weeks prior to randomization (including but not limited to
topical corticosteroids, topical retinoid or vitamin D analog preparations,
tacrolimus, pimecrolimus, or anthralin/dithranol)
Exceptions*:
i. Low potency or weak corticosteroids (please refer to the Investigators' Manual)
will be allowed as background therapy for treatment of the face, axillae and groin in
accordance with manufacturer's suggested usage ii. Unmedicated skin moisturizer (eg,
Eucerin®) will also be permitted for body lesions
*Subjects should not use these topical treatments within 24 hours prior to the clinic
visit.
b. Conventional systemic therapy for psoriasis within 4 weeks prior to randomization
c. Phototherapy treatment (ie, ultraviolet B [UVB], PUVA) within 4 weeks prior to
randomization d. Biologic therapy within 4 weeks prior to randomization or 5 PK/PD
half-lives (whichever is longer).
Ages Eligible for Study
6 Years - 17 Years
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Research Team @ Pediatric Dermatology
650-724-1982
Not Recruiting