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
Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects
This is a prospective, randomized, double-blinded, placebo-controlled, multi-center, Phase 3 study of GLSI-100 immunotherapy in HLA-A*02 positive and HER2/neu positive subjects who are at high risk for disease recurrence and have completed both neoadjuvant and postoperative adjuvant standard of care therapy. Treatment consists of 6 intradermal injections, Primary Immunization Series (PIS), over the first 6 months of treatment and 5 booster intradermal injections spaced 6 months apart. A third open-label arm will explore GLSI-100 immunotherapy in non-HLA-A*02 positive and HER2/neu positive subjects.
Stanford is currently accepting patients for this trial.
Intervention(s):
- biological: Placebo
- biological: GLSI-100
Eligibility
Inclusion Criteria:
- HLA-A*02-positive, unless being enrolled in the third non-HLA-A*02 arm
- Histologically confirmed diagnosis of HER2/neu positive primary breast cancer
- Completion of both neoadjuvant and adjuvant trastuzumab-based standard of care breast
cancer therapy
- Stage I, II, or III at presentation with pathologic evidence of residual invasive
carcinoma in the breast or axillary lymph nodes (residual disease) at surgery
following completion of neoadjuvant therapy -OR- Stage III at presentation with
pathologic complete response (pCR) at surgery following completion of neoadjuvant
therapy
- The subject can begin study therapy within one year of completion of adjuvant
trastuzumab-based therapy and any other standard therapies, but, study therapy can be
administered concurrently with endocrine therapy.
- No clinical evidence of residual or persistent breast cancer per treating physician
assessment
- ECOG 0-2
- Adequate organ function
- Negative pregnancy test or evidence of post-menopausal status
- If of childbearing potential, willing to use a form of highly effective contraception
Exclusion Criteria:
- Stage IV cancer or metastatic breast cancer at any time
- Inflammatory breast cancer
- Receiving other investigational agents
- Receiving chemotherapy
- Requiring long-term systemic treatment with corticosteroids or other immunosuppressive
therapy
- History of immunodeficiency or active autoimmune disease
- A history of serious allergic reactions, including anaphylaxis, to human
granulocyte-macrophage colony-stimulating factors such as sargramostim, yeast-derived
products, or any component of the investigational product
- Other malignancies except adequately treated in situ carcinoma of the cervix or basal
cell or squamous cell carcinoma of the skin
- Active infection
- Known HIV infection with a detectable viral load within 6 months of the anticipated
start of treatment. Note: Subjects on effective antiretroviral therapy with an
undetectable viral load within 6 months of the anticipated start of treatment are
eligible for this trial.
Ages Eligible for Study
18 Years - 100 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Michelle Le
michmle@stanford.edu
I'm interested
Psoriasis Clinical Trials
Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects
This is a prospective, randomized, double-blinded, placebo-controlled, multi-center, Phase 3 study of GLSI-100 immunotherapy in HLA-A*02 positive and HER2/neu positive subjects who are at high risk for disease recurrence and have completed both neoadjuvant and postoperative adjuvant standard of care therapy. Treatment consists of 6 intradermal injections, Primary Immunization Series (PIS), over the first 6 months of treatment and 5 booster intradermal injections spaced 6 months apart. A third open-label arm will explore GLSI-100 immunotherapy in non-HLA-A*02 positive and HER2/neu positive subjects.
Stanford is currently accepting patients for this trial.
Intervention(s):
- biological: Placebo
- biological: GLSI-100
Eligibility
Inclusion Criteria:
- HLA-A*02-positive, unless being enrolled in the third non-HLA-A*02 arm
- Histologically confirmed diagnosis of HER2/neu positive primary breast cancer
- Completion of both neoadjuvant and adjuvant trastuzumab-based standard of care breast
cancer therapy
- Stage I, II, or III at presentation with pathologic evidence of residual invasive
carcinoma in the breast or axillary lymph nodes (residual disease) at surgery
following completion of neoadjuvant therapy -OR- Stage III at presentation with
pathologic complete response (pCR) at surgery following completion of neoadjuvant
therapy
- The subject can begin study therapy within one year of completion of adjuvant
trastuzumab-based therapy and any other standard therapies, but, study therapy can be
administered concurrently with endocrine therapy.
- No clinical evidence of residual or persistent breast cancer per treating physician
assessment
- ECOG 0-2
- Adequate organ function
- Negative pregnancy test or evidence of post-menopausal status
- If of childbearing potential, willing to use a form of highly effective contraception
Exclusion Criteria:
- Stage IV cancer or metastatic breast cancer at any time
- Inflammatory breast cancer
- Receiving other investigational agents
- Receiving chemotherapy
- Requiring long-term systemic treatment with corticosteroids or other immunosuppressive
therapy
- History of immunodeficiency or active autoimmune disease
- A history of serious allergic reactions, including anaphylaxis, to human
granulocyte-macrophage colony-stimulating factors such as sargramostim, yeast-derived
products, or any component of the investigational product
- Other malignancies except adequately treated in situ carcinoma of the cervix or basal
cell or squamous cell carcinoma of the skin
- Active infection
- Known HIV infection with a detectable viral load within 6 months of the anticipated
start of treatment. Note: Subjects on effective antiretroviral therapy with an
undetectable viral load within 6 months of the anticipated start of treatment are
eligible for this trial.
Ages Eligible for Study
18 Years - 100 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Michelle Le
michmle@stanford.edu
I'm interested
Dermatology Clinical Trials
Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects
This is a prospective, randomized, double-blinded, placebo-controlled, multi-center, Phase 3 study of GLSI-100 immunotherapy in HLA-A*02 positive and HER2/neu positive subjects who are at high risk for disease recurrence and have completed both neoadjuvant and postoperative adjuvant standard of care therapy. Treatment consists of 6 intradermal injections, Primary Immunization Series (PIS), over the first 6 months of treatment and 5 booster intradermal injections spaced 6 months apart. A third open-label arm will explore GLSI-100 immunotherapy in non-HLA-A*02 positive and HER2/neu positive subjects.
Stanford is currently accepting patients for this trial.
Intervention(s):
- biological: Placebo
- biological: GLSI-100
Eligibility
Inclusion Criteria:
- HLA-A*02-positive, unless being enrolled in the third non-HLA-A*02 arm
- Histologically confirmed diagnosis of HER2/neu positive primary breast cancer
- Completion of both neoadjuvant and adjuvant trastuzumab-based standard of care breast
cancer therapy
- Stage I, II, or III at presentation with pathologic evidence of residual invasive
carcinoma in the breast or axillary lymph nodes (residual disease) at surgery
following completion of neoadjuvant therapy -OR- Stage III at presentation with
pathologic complete response (pCR) at surgery following completion of neoadjuvant
therapy
- The subject can begin study therapy within one year of completion of adjuvant
trastuzumab-based therapy and any other standard therapies, but, study therapy can be
administered concurrently with endocrine therapy.
- No clinical evidence of residual or persistent breast cancer per treating physician
assessment
- ECOG 0-2
- Adequate organ function
- Negative pregnancy test or evidence of post-menopausal status
- If of childbearing potential, willing to use a form of highly effective contraception
Exclusion Criteria:
- Stage IV cancer or metastatic breast cancer at any time
- Inflammatory breast cancer
- Receiving other investigational agents
- Receiving chemotherapy
- Requiring long-term systemic treatment with corticosteroids or other immunosuppressive
therapy
- History of immunodeficiency or active autoimmune disease
- A history of serious allergic reactions, including anaphylaxis, to human
granulocyte-macrophage colony-stimulating factors such as sargramostim, yeast-derived
products, or any component of the investigational product
- Other malignancies except adequately treated in situ carcinoma of the cervix or basal
cell or squamous cell carcinoma of the skin
- Active infection
- Known HIV infection with a detectable viral load within 6 months of the anticipated
start of treatment. Note: Subjects on effective antiretroviral therapy with an
undetectable viral load within 6 months of the anticipated start of treatment are
eligible for this trial.
Ages Eligible for Study
18 Years - 100 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Michelle Le
michmle@stanford.edu
I'm interested
Pediatric Dermatology Clinical Trials
Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects
This is a prospective, randomized, double-blinded, placebo-controlled, multi-center, Phase 3 study of GLSI-100 immunotherapy in HLA-A*02 positive and HER2/neu positive subjects who are at high risk for disease recurrence and have completed both neoadjuvant and postoperative adjuvant standard of care therapy. Treatment consists of 6 intradermal injections, Primary Immunization Series (PIS), over the first 6 months of treatment and 5 booster intradermal injections spaced 6 months apart. A third open-label arm will explore GLSI-100 immunotherapy in non-HLA-A*02 positive and HER2/neu positive subjects.
Stanford is currently accepting patients for this trial.
Intervention(s):
- biological: Placebo
- biological: GLSI-100
Eligibility
Inclusion Criteria:
- HLA-A*02-positive, unless being enrolled in the third non-HLA-A*02 arm
- Histologically confirmed diagnosis of HER2/neu positive primary breast cancer
- Completion of both neoadjuvant and adjuvant trastuzumab-based standard of care breast
cancer therapy
- Stage I, II, or III at presentation with pathologic evidence of residual invasive
carcinoma in the breast or axillary lymph nodes (residual disease) at surgery
following completion of neoadjuvant therapy -OR- Stage III at presentation with
pathologic complete response (pCR) at surgery following completion of neoadjuvant
therapy
- The subject can begin study therapy within one year of completion of adjuvant
trastuzumab-based therapy and any other standard therapies, but, study therapy can be
administered concurrently with endocrine therapy.
- No clinical evidence of residual or persistent breast cancer per treating physician
assessment
- ECOG 0-2
- Adequate organ function
- Negative pregnancy test or evidence of post-menopausal status
- If of childbearing potential, willing to use a form of highly effective contraception
Exclusion Criteria:
- Stage IV cancer or metastatic breast cancer at any time
- Inflammatory breast cancer
- Receiving other investigational agents
- Receiving chemotherapy
- Requiring long-term systemic treatment with corticosteroids or other immunosuppressive
therapy
- History of immunodeficiency or active autoimmune disease
- A history of serious allergic reactions, including anaphylaxis, to human
granulocyte-macrophage colony-stimulating factors such as sargramostim, yeast-derived
products, or any component of the investigational product
- Other malignancies except adequately treated in situ carcinoma of the cervix or basal
cell or squamous cell carcinoma of the skin
- Active infection
- Known HIV infection with a detectable viral load within 6 months of the anticipated
start of treatment. Note: Subjects on effective antiretroviral therapy with an
undetectable viral load within 6 months of the anticipated start of treatment are
eligible for this trial.
Ages Eligible for Study
18 Years - 100 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Michelle Le
michmle@stanford.edu
I'm interested
Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects
This is a prospective, randomized, double-blinded, placebo-controlled, multi-center, Phase 3 study of GLSI-100 immunotherapy in HLA-A*02 positive and HER2/neu positive subjects who are at high risk for disease recurrence and have completed both neoadjuvant and postoperative adjuvant standard of care therapy. Treatment consists of 6 intradermal injections, Primary Immunization Series (PIS), over the first 6 months of treatment and 5 booster intradermal injections spaced 6 months apart. A third open-label arm will explore GLSI-100 immunotherapy in non-HLA-A*02 positive and HER2/neu positive subjects.
Stanford is currently accepting patients for this trial.
Intervention(s):
- biological: Placebo
- biological: GLSI-100
Eligibility
Inclusion Criteria:
- HLA-A*02-positive, unless being enrolled in the third non-HLA-A*02 arm
- Histologically confirmed diagnosis of HER2/neu positive primary breast cancer
- Completion of both neoadjuvant and adjuvant trastuzumab-based standard of care breast
cancer therapy
- Stage I, II, or III at presentation with pathologic evidence of residual invasive
carcinoma in the breast or axillary lymph nodes (residual disease) at surgery
following completion of neoadjuvant therapy -OR- Stage III at presentation with
pathologic complete response (pCR) at surgery following completion of neoadjuvant
therapy
- The subject can begin study therapy within one year of completion of adjuvant
trastuzumab-based therapy and any other standard therapies, but, study therapy can be
administered concurrently with endocrine therapy.
- No clinical evidence of residual or persistent breast cancer per treating physician
assessment
- ECOG 0-2
- Adequate organ function
- Negative pregnancy test or evidence of post-menopausal status
- If of childbearing potential, willing to use a form of highly effective contraception
Exclusion Criteria:
- Stage IV cancer or metastatic breast cancer at any time
- Inflammatory breast cancer
- Receiving other investigational agents
- Receiving chemotherapy
- Requiring long-term systemic treatment with corticosteroids or other immunosuppressive
therapy
- History of immunodeficiency or active autoimmune disease
- A history of serious allergic reactions, including anaphylaxis, to human
granulocyte-macrophage colony-stimulating factors such as sargramostim, yeast-derived
products, or any component of the investigational product
- Other malignancies except adequately treated in situ carcinoma of the cervix or basal
cell or squamous cell carcinoma of the skin
- Active infection
- Known HIV infection with a detectable viral load within 6 months of the anticipated
start of treatment. Note: Subjects on effective antiretroviral therapy with an
undetectable viral load within 6 months of the anticipated start of treatment are
eligible for this trial.
Ages Eligible for Study
18 Years - 100 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Michelle Le
michmle@stanford.edu
I'm interested
Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects
This is a prospective, randomized, double-blinded, placebo-controlled, multi-center, Phase 3 study of GLSI-100 immunotherapy in HLA-A*02 positive and HER2/neu positive subjects who are at high risk for disease recurrence and have completed both neoadjuvant and postoperative adjuvant standard of care therapy. Treatment consists of 6 intradermal injections, Primary Immunization Series (PIS), over the first 6 months of treatment and 5 booster intradermal injections spaced 6 months apart. A third open-label arm will explore GLSI-100 immunotherapy in non-HLA-A*02 positive and HER2/neu positive subjects.
Stanford is currently accepting patients for this trial.
Intervention(s):
- biological: Placebo
- biological: GLSI-100
Eligibility
Inclusion Criteria:
- HLA-A*02-positive, unless being enrolled in the third non-HLA-A*02 arm
- Histologically confirmed diagnosis of HER2/neu positive primary breast cancer
- Completion of both neoadjuvant and adjuvant trastuzumab-based standard of care breast
cancer therapy
- Stage I, II, or III at presentation with pathologic evidence of residual invasive
carcinoma in the breast or axillary lymph nodes (residual disease) at surgery
following completion of neoadjuvant therapy -OR- Stage III at presentation with
pathologic complete response (pCR) at surgery following completion of neoadjuvant
therapy
- The subject can begin study therapy within one year of completion of adjuvant
trastuzumab-based therapy and any other standard therapies, but, study therapy can be
administered concurrently with endocrine therapy.
- No clinical evidence of residual or persistent breast cancer per treating physician
assessment
- ECOG 0-2
- Adequate organ function
- Negative pregnancy test or evidence of post-menopausal status
- If of childbearing potential, willing to use a form of highly effective contraception
Exclusion Criteria:
- Stage IV cancer or metastatic breast cancer at any time
- Inflammatory breast cancer
- Receiving other investigational agents
- Receiving chemotherapy
- Requiring long-term systemic treatment with corticosteroids or other immunosuppressive
therapy
- History of immunodeficiency or active autoimmune disease
- A history of serious allergic reactions, including anaphylaxis, to human
granulocyte-macrophage colony-stimulating factors such as sargramostim, yeast-derived
products, or any component of the investigational product
- Other malignancies except adequately treated in situ carcinoma of the cervix or basal
cell or squamous cell carcinoma of the skin
- Active infection
- Known HIV infection with a detectable viral load within 6 months of the anticipated
start of treatment. Note: Subjects on effective antiretroviral therapy with an
undetectable viral load within 6 months of the anticipated start of treatment are
eligible for this trial.
Ages Eligible for Study
18 Years - 100 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Michelle Le
michmle@stanford.edu
I'm interested