Clinical trial review

Journal of Drugs in Dermatology, June, 2008

Clinical Trial Review is designed to provide physicians with as much information as possible about drugs undergoing Phase 1,.2, and 3 clinical testing. It is our goal to inform the reader of the up-to-date status of these drug trials before this information is available through standard channels: To participate in or learn more about these and additional trials, visit www.clinicaltrials.gov.

ATOPIC DERMATITIS

The Impact of Treating Staphylococcus Aureus Infection and Colonization on the Clinical Severity of Atopic Dermatitis

Sponsors and Collaborators: Children's Memorial Hospital, Society for Pediatric Dermatology, Johnson & Johnson. We would like to perform a randomized investigator-blinded placebo-controlled study of children aged 6 months to 17 years with moderate to severe atopic dermatitis with clinical signs of secondary bacterial infection to study: 1) the prevalence of CA-MRSA in our patient population; 2) the relationship of sensitivity of the S aureus organism cultured from the infected lesion(s) to clinical response to oral cephalexin therapy and severity of the AD; and 3) whether concurrent treatment of S aureus infection initially with nasal mupirocin ointment and sodium hypochlorite (bleach) baths can result in long-term S aureus eradication and clinical stability.

Condition             Intervention                     Phase

Atopic Dermatitis     Drug: Sodium hypochlorite baths  Phase 4
                      Drug: Mupirocin ointment
                      Drug: Cephalexin

Study ID Numbers: 12624

ClinicalTrials.gov Identifier: NCT00179959

A Study of the Safety and Efficacy of JNJ-26113100 in the Treatment of Adult Atopic Dermatitis

Sponsored by Alza Corporation, DE, USA. The purpose of this study is to evaluate the safety and effectiveness of oral administration of 4 dose regimens of JNJ-26113100 prepared in a capsule formulation administered for 6 weeks in the treatment of adult atopic dermatitis that is moderate in severity.

Condition          Intervention       Phase

Atopic Dermatitis  Drug:JNJ-26113100  Phase 2

Study ID Numbers: CR012946

ClinicalTrials.gov Identifier: NCT00455429

A Pediatric Longitudinal Evaluation to Assess the Long-Term Safety of Protopic for the Treatment of Atopic Dermatitis (APPLES)

Sponsored by Astellas Pharma Inc. This is an observational study to assess the long-term safety of Protopic[R] Ointment for the treatment of atopic dermatitis. Patients whose ages are/were < 16 years at the time of first tacrolimus ointment exposure are eligible to participate. No drug is distributed during this observational trial.

Condition

Atopic Dermatitis

Study ID Numbers: 03-0-161, FG506-06-37

ClinicalTrials.gov Identifier: NCT00475605

ACNE

Photodynamic Therapy (PDT) With Methyl Aminolevulinate (MAL) Cream in Moderate to Severe Acne

Sponsored by PhotoCure. This multicenter study will be divided into 2 phases. The first phase will be an open label, dose-escalation phase, while the second will be a blinded, randomized, vehicle-controlled, parallel-group, dose-response phase. The second phase will only start if the first phase succeeds in establishing well tolerated dose(s). Patients with moderate to severe acne vulgaris in the face will be included.

Condition      Intervention                            Phase

Acne Vulgaris  Drug: Methyl aminolevulinate (MAL) PDT  Phase 2

Study ID Numbers: PC TA202B/06

ClinicalTrials.gov Identifier: NCT00594425

Non-Cutting Laser Therapy in the Treatment of Acne

Sponsored by University of Michigan. In this study, we are interested in learning how well such a laser works to improve the symptoms of acne, as well as how much the photo-sen-sitizer actually enhances the efficacy of the laser.

Condition      Intervention                          Phase

Acne Vulgaris  Device: V-Beam laser, Candela Corp.,  Phase 2
               595 nm wavelength

Study ID Numbers: Derm 548

ClinicalTrials.gov Identifier: NCT00113425

Clinical Study to Test the Efficacy and Safety of Adapalene, 0.1%

Sponsored by Galderma. The purpose of this study is to determine whether Adapalene 0.1 % is safe and effective in the treatment of Acne Vulgaris.

Condition      Intervention                   Phase

Acne Vulgaris  Drug: Adapalene Drug: Vehicle  Phase 3

Study ID Numbers: RD.o6.SPR.18114, IND 076057

ClinicalTrials.gov Identifier: NCT00599521

CONNECTIVE TISSUE DISORDERS

Imiquimod in Childern With Plaque Morphea

Sponsored by The Hospital for Sick Childern. We propose to conduct a pilot study to assess to potential efficacy and relative safety of Imiquimod in childern with plaque morphea.

Condition               Intervention     Phase

Scleroderma, Localized  Drug: Imiquimod  Phase 3

Study ID Numbers: 1000007595

ClinicalTrials.gov Identifier: NCT00147771

UVA1 Light for Treatment of Scleroderma and Similar Conditions

Sponsored by University of Michigan. The purpose of this investigation is to evaluate the effectiveness of an investigational device which is similar in appearance to a "tanning bed" but which emits ultraviolet irradiation of a specific wavelength known as UVA1.