Past Clinical Trials/Closed to Enrollment

Psoriasis

Psoriasis is a chronic, immune-mediated disease that causes red, silvery-white scaly patches on the skin called plaque. These patches may be itchy, flaky and irritating. Plaque psoriasis may cover large regions of the body, and in some cases cause pain and bleeding.

Psoriasis is a life-long condition and although no known cure exists, several treatments are available that may reduce or eliminate psoriasis outbreaks. The UC Irvine Health Dermatology Research Center studies several different treatment options, including oral medications, topical ointments and injectable drugs that are both FDA and non-FDA approved.

• Study Title: A Phase 3 Study to Evaluate the Efficacy and Safety of Induction and Maintenance Regimens of Brodalumab Compared With Placebo and Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis: AMAGINE-2. 
• Study Title: A Phase 3b, Multicenter, Randomized, Placebo-Controlled, Double Blind, Double-Dummy, Study of the Efficacy and Safety of Apremilast (CC-10004), Etanercept, and Placebo, in Subjects with Moderate to Severe Plaque Psoriasis. 
• Study Title: A Phase 2B, Multi-Site, Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group Study of the Efficacy, Safety, Local Tolerability and Pharmacokinetics of 2 Dose Strengths and 2 Regimens of Tofacitinib Ointment in Subjects with Chronic Plaque Psoriasis. 
• Study Title: An Open-label Study to Evaluate the Effect of Brodalumab on the Pharmacokinetics of Midazolam and Assess Single-Dose Brodalumab Pharmacokinetics in Subjects with Moderate to Severe Plaque Psoriasis.  
• Study Title: A Phase 1, Open-Label Study, to Evaluate the Safety and Efficacy of KD025 Treatment in Subjects with Psoriasis Vulgaris.
• Study Title: A 12-Week Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of LY2439821 to Etanercept and Placebo in Patients with Moderate to Severe Plaque Psoriasis with a Long-Term Extension Period.
• Study Title: A Phase 3b, Randomized, Double-Blind, Active-controlled, Multicenter Study to Evaluate a "Subject-tailored" Maintenance Dosing Approach in Subjects with Moderate-to-Severe Plaque Psoriasis.
• Study Title: A Phase 3, Multi-Site, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of 2 Oral Doses of CP-690,550 in Subjects with Moderate to Severe Chronic Plaque Psoriasis. 
• Study Title: An Open-label Study to Evaluate the Efficacy of Etanercept Treatment in Subjects with Moderate to Severe Plaque Psoriasis Who Have Lost a Satisfactory Response to Adalimumab.
• Study Title: A Prospective, Observational Study to Estimate the Proportion of Subjects with Plaque Psoriasis who Achieve Complete Clearance on Biologics.
• Study Title: An Observation Evaluation of Vitamin D Levels in Psoriasis Patients. 

Submental Fat Reduction

The accumulation of fat under the chin, also known as submental fat, is a common condition that is not necessarily linked to being overweight. In the past, cosmetic treatments for submental fat have been invasive and uncomfortable, and many patients are wary of surgical procedures. Our research team investigated alternative treatments for submental fat that are more conservative than traditional methods such as liposuction.

• Study Title: A multicenter, randomized, double-blind, placebo-controlled, Phase 3 study of ATX-101 (sodium deoxycholate injection) versus placebo for the reduction of localized subcutaneous fat in the submental area.
  • Study Description: This study is investigated a novel biologic of sodium deoxycholate (ATX-101), which is an injection designed to reduce fat deposits under the skin. Photographs will be taken throughout treatment to assess the efficacy of ATX-101 in reducing submental fat.

Infantile Hemangioma

During the first several weeks of life, newborn infants may develop benign tumors known as infantile hemangiomas. These red and swollen birthmarks are relatively common and harmless, but in some cases the hemangioma may cause complications such as tissue damage and disfigurement. Currently, corticosteroids are the standard treatment for infantile hemangioma; however, some infants do not respond, and side effects are a cause of concern for many parents.

• Study Title: A randomized, controlled, multidose, multicentre, adaptive phase II/III study in infants with proliferating infantile hemangiomas requiring systemic therapy to compare four regimens of propranolol (1 or 3 mg/kg/day for 3 or 6 months) to placebo.
  • Study Description: This study is being conducted to determine the safety and efficacy of an oral solution, V00400SB, in treating infantile hemangioma. It is a known beta blocker with a long history of treating high blood pressure and heart diseases in children and adults.

Nasolabial Folds

Commonly called "laugh lines" or "smile lines," nasolabial folds are facial indentations that run from either side of the nose to the corners of the mouth. These facial features become more pronounced with age, and may cause cosmetic concern for some.

• Study Title: Post-Approval Study of ArteFill for Correction of Nasolabial Folds.
  • Study Description: This study is to investigate the efficacy and safety of ArteFill® in reducing the appearance of nasolabial folds.  The study will be closely monitored for any adverse events, and patient satisfaction with the treatment will be assessed throughout the study.

Breast Scar Reduction

Individuals who undergo breast augmentation or reconstruction procedures may observe scars at the site of surgery.  One form of scars, known as hypertrophic scars, are pronounced and may be of cosmetic concern. 

• Study Title: A Phase 2, Randomized Double-Blind, Within-Subject, Placebo Controlled Study to Evaluate the Efficacy and Safety of PF-06473871.
  • Study Description: The purpose of this study is to evaluate the safety and efficacy of PF-06473871 in reducing the appearance of hypertrophic breast scars. PF-06473871 is injected into the scar and acts by inhibiting growth of scar tissue. 

Actinic Keratosis

Actinic keratosis is a pre-cancerous growth on the skin. Actinic keratosis (AK) is very common, especially in people who have had considerable exposure to the sun. they appear as small red patches that are rough and dry. The patches are usually seen on the sun exposed areas, such as the face, scalp, ears, arms and upper chest.

• Study Title: A Randomized, Double-Blind, Placebo-Controlled Phase II/III Clinical Trial of Celecoxib in Patient’s with Actinic Keratosis.
  • Study Description: The Department of Dermatology recently conducted a clinical trial examining a light treatment to treat solid organ transplant patients who have multiple AKs. These patients often have more AK's than the normal population.

Laser Hair Removal

Laser hair removal is becoming an increasingly popular method to remove unwanted hair on the body. Many different types of lasers are now used for this purpose. However, there continues to be a need for a laser that offers effective hair removal, while providing comfort and efficiency for the patient.

• Study Title: Side-by-Side Comparison of 810 nm Diode Laser Technology with Low Fluence-High Repetition Rate vs Low Fluence-Vacuum Assist-A Split Extremity Efficacy Safety and Tolererability Study
  • Study Description: Our researchers are conducting a clinical research study comparing two laser systems.

Port-wine Stain

Port-wine stains are vascular birthmarks that produce a red to purple discoloration of the skin. 

• Study Title: Novel Treatment for Port Wine Stain Birthmarks.
  • Study Description: Our researchers, in conjunction with the Beckman Laser Institute & Medical Clinic, are conducting an innovative study combining laser treatment and a topical cream to lighten these birthmarks.  In order to participate in this study, patients must have lighter skin to avoid discoloration from the laser.

Vitiligo

Vitiligo is a relatively common disorder that causes depigmentation (loss of color) of skin. Patients with this disease have white patches of the skin.

There is an international team of scientists working to find the genes that cause vitiligo. Thus far, at least five genes on chromosomes 1, 7, 8, 9 and 17 have been found to contribute to the condition in different families. We don't know what most of these genes are yet, and so we are seeking additional patients and families to narrow our search.  At UC Irvine, we are looking for patients with vitiligo and their family members to provide a small amount of medical information and a saliva sample for chromosome analysis.

Discoid Lupus Erythematosus

Discoid lupus erythematosus (DLE) is an autoimmune disease that involves multiple organ systems, often forming red or purple disc shaped lesions on the skin. DLE can cause permanent hair loss and skin discoloration, and can be a significant source of disability. Currently, there are very few treatment options available for patients with DLE. 

• Study Title: Proof-of-Concept Study of IVIg Efficacy in Patients with Cutaneous Lupus Erythematosus. 
  • Study Description: Our investigators will be assessing the safety and tolerability of an experimental drug, CC-930. This oral medication reduces chemicals that cause local inflammation, and blocking these chemicals may treat the symptoms of DLE.

Atopic Dermatitis

Atopic dermatitis is a common chronic skin disease where the skin becomes excessively dry and does not function properly as a barrier to the outside environment. Water loss from the skin is a common concern, as well as the fact that environmental allergens may more readily gain entry to the deeper layers of skin and cause a hypersensitive reaction.  

• Study Title: A Multiple-Dose (0.3%, 1% and 3% [w/w]), Randomized, Blinded, Vehicle-and Active Comparator-Controlled, Sequential Dose Cohorts, Multi-Center Trial to Assess the Safety, Pharmacokinetics, and Proof-of Concept Efficacy of Topical OPA-15406 Ointment, Applied Twice Daily for 28 days, In Adult Subjects with Atopic Dermatitis. 
• Study Title: A Multi-Center, Open Label, Phase 1 Study to Evaluate the Safety of Both MSRD-100 (Fluticasone Propionate) Gel 0.025% and Fluticasone Propionate Cream 0.05%, Including its Effects on the Hypothalamic Pituitary Adrenal (HPA) Axis in the Treatment of Atopic Dermatitis in Pediatric Subjects.

Acne

Acne is a common skin disease that causes pimples.  Usually occurring on the face and shoulders, acne is most prevalent in teenagers.

• Study Title: A Safety and Efficacy Study to Compare Dapsone Dermal Gel with Vehicle Control in Patients with Acne Vulgaris. 
  • Sutdy Description: This study is designed to assess the safety and efficacy of dapsone 7.5% gel versus vehicle control administered topically once daily for 12 weeks in patients with acne vulgaris.  Dapsone 5% is FDA approved and widely available.  Procedures include medical history and acne assessment.  Facial photography is optional.  Participants must be 12 years of age and older.
• Study Title:  A Multicenter, Randomized, Double Blind, Parallel, Placebo and Active Controlled, In Vivo Bioequivalence with Clinical Endpoint Study to Determine the Bioequivalence of Test Product Benzoyl peroxide (5%) + Clindamycin Phosphate (Equivalent to 1% base) Topical Gel and Reference Product BenzaClin Topical Gel in Subjects with Acne Vulgaris. 
  • Study Description: This study is designed to prove the bioequivalence of the generic product to BenzaClin in order to bring down the cost of the therapy.  Study drug is applied twice daily, once in the morning and once in the evening for 70 days (10 weeks).

Pemphigus

Pemphigus is an autoimmune disease characterized by blistering, caused by autoantibodies against certain cells in the skin.  This disease most commonly occurs in individuals ages 50 and older, and it presents as painful shallow erosions and/or blisters in the mouth and/or skin.  

• Study title:  Evaluation of Sirolimus for the Treatment of the Autoimmune Blistering Dermatosis Pemphigus
  • Study Description: The purpose of this research is to study alternative treatments for the skin disease pemphigus by using sirolimus, an immunosuppressive drug.

Cutaneous Lupus Erythematosus

Cutaneous Lupus Erythematosus (CLE) is a relatively rare chronic autoimmune inflammatory skin disease that may cause permanent scarring. The current treatments available for CLE are systemic immunosuppressive and anti-inflammatory agents. 

• Study title:  Proof-of-Concept Study of IVIg Efficacy in Patients with Cutaneous Lupus Erythematosus
  • Study Description: While current available treatments have lead to remission, the purpose of this study is to develop an alternative treatment that maintains remission. The ultimate goal of this pilot project is to generate proof-of-concept data showing that treatment with intravenous immunoglobulin (IVIg) can replace current systemic immunosuppressive therapy in CLE patients.  IVIg has been used for a variety of immune-mediated diseases that is both safe and efficacious.

Parkinson Disease

Parkinson Disease is a brain disorder that occurs when nerve cells in the brain don't produce enough of a brain chemical called dopamine The four primary symptoms of PD are tremor, or trembling in hands, arms, legs, jaw, and face; rigidity, or stiffness of the limbs and trunk; bradykinesia, or slowness of movement; and postural instability, or impaired balance and coordination. The average age of onset is 60 years

• Study Title: A double-blind, randomized, placebo-controlled study of the safety and efficacy of SYN115 as adjunctive therapy in levodopa-treated Parkinson’s subjects with end of dose wearing off.
• Study Title: A Phase 3, 12-Week, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease

Alzheimers Disease

Alzheimer disease (AD) is the leading cause of age-related dementia, affecting over 5 million people in the United States alone. AD patients suffer from progressive neurodegenerative that gradually impairs their memory, ability to learn, and carry out daily activities. Unfortunately, current therapies are palliative and several promising drug candidates have recently failed in latest clinical trials. It is therefore critical to improve our understanding of AD and develop new and effective therapies. In the last few years, scientists have identified ways to create human stem cells from patient’s own skin or blood cells. These induced pluripotent stem cells (iPSC) can then been grown in the lab and used to produce any cell type in the body including brain neurons. These iPSCs could therefore provide scientists with a promising new way to study human disease and test and develop new therapies. 

• Study Title: Generation of induced pluripotent stem (iPS) cell lines for the study of Alzheimer disease
  • Study Description: The purpose of this research is to establish a collection of well characterized integration-free iPSC and iNSC lines from participants enrolled in the Alzheimer Disease Research Center (ADRC) Cohorts.

Tuberous sclerosis

Tuberous sclerosis is a genetic condition that is characterized by the accumulation of spots on the skin that have no skin pigment The first sign of tuberous sclerosis at birth is the presence of “ash-leaf spots.” Ash-leaf spots are caused by the lack of melanin—a skin pigment that protects the skin and eyes from the harmful effects of UV. Regions on the skin appear white due to the lack of melanin. Patients with tuberous sclerosis have mutations in the mTOR gene. This gene influences the cells in the body and plays key roles in cell physiology and disease states.  Defects in the mTOR gene may initiate a sequence of molecular events that cause these white spots. 

• Study title: Role of Phosphoinositide Signaling Regulates Melanogenesis
  • Study Description: The purpose of this study is to determine how mTOR mutations affect the production of skin pigments in those with tuberous sclerosis.  Participants must have tuberous sclerosis and consent to provide a skin biopsy for analysis. Information from this study will be collected and analyzed to help understand the pharmacokinetics of tuberous sclerosis and aid in the research and development of potential new drugs and treatments for the disease.