Clinical trial review

Journal of Drugs in Dermatology, Dec, 2003

CLINICAL TRIAL OF HUMAX-CD4, A NEW DRUG TO TREAT ADVANCED STAGE T-CELL LYMPHOMA IN THE SKIN

This study is currently recruiting patients.

Sponsored by: Genmab

The purpose of this trial is to determine the effect of HuMax-CD4, as a treatment for advanced stage (late stage) cutaneous T-cell lymphoma (CTCL). Almost all patients who are affected by late stage CTCL have many cancerous cells which bear a receptor called CD4. HuMax-CD4 is an investigational drug directed against this receptor. There is no placebo in this trial; all patients will be treated with HuMax-CD4. The response rates, duration of responses, relief of symptoms, and safer7 profile of HuMax-CD4 will be evaluated during this trial.

Condition                   Treatment or Intervention   Phase

Cutaneous T-Cell Lymphoma   Drug: HuMax-CD4             Phase II

Study ID Number: Hx-CD4-008

NLM Identifier: NCT00071084

PHASE 2 TRIAL OF TD 6424 VERSUS STANDARD THERAPY FOR COMPLICATED GRAM POSITIVE SKIN AND SKIN STRUCTURE INFECTIONS

This study is currently recruiting patients.

Sponsored by: Theravance

Serious infections caused by resistant bacteria are becoming more of a medical problem throughout the world. One of the ways to deal with this problem is to develop new drugs that can control these bacteria. This study will measure how well TD-6424 can control infections and whether this drug can be safely given to patients.

Condition                   Treatment or Intervention   Phase

Infections, Gram-Positive   Drug: TD-6424               Phase II
  Bacterial
Abscess
Burns
Cellulitis
Ulcer
Wound Infections

Study ID Numbers: 16424-202a; FAST

NLM Identifier: NCT00061633

PHOTODYNAMIC THERAPY IN TREATING PATIENTS WITH SKIN CANCER

This study is currently recruiting patients.

Sponsored by: Roswell Park Cancer Institute, National Cancer Institute (NCI)

Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. Photodynamic therapy using aminolevulinic acid may be effective in treating patients with skin cancer. This randomized phase II trial will study the effectiveness of photodynamic therapy that includes aminolevulinic acid in treating patients with skin cancer.

Condition                          Treatment or Intervention   Phase

Basal cell carcinoma of the skin   Drug: Aminolevulinic acid   Phase II
Squamous cell carcinoma of the
  skin                             Procedure: Laser therapy
Actinic keratosis                  Procedure: Photodynamic
                                   therapy
                                   Procedure: Phototherapy

Study ID Numbers: CDR0000065494; RPCI-DS-96-55; NCI-G97-1224

NLM Identifier: NCT00002975

PHASE III RANDOMIZED STUDY OF ORAL ACYCLOVIR IN INFANTS WITH HERPES SIMPLEX VIRUS INFECTION LIMITED TO SKIN, EYES, AND MOUTH

This study is currently recruiting patients.

Sponsored by: National Center for Research Resources (NCRR), UAB Comprehensive Cancer Center

This study will determine the efficacy of long term suppressive therapy with oral acyclovir in infants with herpes simplex virus infection limited to skin, eyes, and mouth, determine the neurologic outcome in these patients when treated with this regimen, evaluate the significance of a positive cerebrospinal fluid (CSF) polymerase chain reaction (PCR) result when all other CSF parameters remain normal in these patients, correlate the time to first positive CSF PCR result in the first 12 months of life with clinical neurological assessment in these patients when treated with this regimen, determine whether the continuous administration of this drug suppresses recurrent skin lesions in these patients, and determine the safety of this regimen in these patients.

Condition        Treatment or Intervention   Phase

Herpes Simplex   Drug: Acyclovir             Phase III

Study ID Numbers: 199/15334; UAB-CASG-104

NLM Identifier: NCT00006135

LEPTIN TO TREAT LIPODYSTROPHY

This study is currently recruiting patients.

Sponsored by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

This study will evaluate the safety and effectiveness of leptin replacement therapy in patients with lipodystrophy (also called lipoatrophy). Patients have a total or partial loss of fat cells. They also lack the hormone leptin, which is produced by fat cells. The leptin deficiency usually causes high blood lipid (fat) levels and insulin resistance that may lead to diabetes. Patients may have hormone imbalances, fertility problems, large appetite, and liver disease due to fat accumulation.

Condition       Treatment or Intervention                  Phase

Lipodystrophy   Drug: Recombinant Methionyl Human Leptin   Phase II
                A-100

Study ID Numbers: 020022; 02-DK-0022

NLM Identifier: NCT00025883

PHASE II RANDOMIZED BILATERAL COMPARISON OF TROPICAL TARGRETIN (BEXAROTENE) GEL 1% IN ALOPECIA AREATA

This study is currently recruiting patients.

Sponsored by: M.D. Anderson Cancer Center, Ligand Pharmaceuticals

The rationale for the use of bexarotene in alopecia areata comes from the drug's immunomodulatory effects. It has been shown to be effective in inflammatory dermatoses, many of which are known to have T-cell mediated mechanisms. Alopecia areata is an organ-specific autoimmune reaction mediated by perifollicular T lymphocytes that clear upon resolution of disease. Therefore, since bexarotene is able to reduce or clear T-cell from the skin in CTCL lesions, we hypothesize that it may be effective in alopecia areata in eliminating the T-cells around the hair follicles.