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Skin Diseases clinical trials

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NCT ID: NCT01938599 Completed - Plaque Psoriasis Clinical Trials

Study Comparing AM001 Cream to Vehicle in the Treatment of Plaque Psoriasis

Start date: August 2013
Phase: Phase 2
Study type: Interventional

To compare the safety and efficacy profile of AM001 Cream and its vehicle in the treatment of plaque psoriasis.

NCT ID: NCT01938508 Completed - Skin Diseases Clinical Trials

Minocycline Bioequivalence Study

Start date: May 2013
Phase: Phase 1
Study type: Interventional

This study compared the bioavailability of two formulations 100 mg (one capsule or other respectively) of each one of the products, of Minocycline, under fasting conditions, in healthy Mexican volunteers of both sexes. The single dose study under fasting (10 hours prior to study) conditions, cross, with two treatments, two periods, two sequences (2x2) randomized sequence, balanced, and with a washout period of at least 7 days between each dose, in 24 healthy volunteers.

NCT ID: NCT01931774 Completed - Acne Vulgaris Clinical Trials

Is Acne a Skin Disease Affecting the Brain Functions? Neurocognition in Patients With Acne Vulgaris

Start date: April 2013
Phase: N/A
Study type: Observational

Acne vulgaris usually causes psychological distress, depression, and anxiety disorders that may impair neurocognitive functions such as memory, attention, psychomotor speed, and executive functions, which are also common psychiatric disorders in patients with acne. The purpose of this study is to determine cognitive functioning in treatment naive acne patients, without a history of any psychiatric disorder.

NCT ID: NCT01917279 Recruiting - Breast Neoplasms Clinical Trials

Capecitabine Maintenance Therapy Following Capecitabine Combined With Docetaxel in Treatment of mBC

CAMELLIA
Start date: October 2013
Phase: Phase 3
Study type: Interventional

It is a phase III trial to explore the efficacy and safety of metronomic chemotherapy with Capecitabine versus intermittent Capecitabine as maintenance therapy following first-line Capecitabine plus Docetaxel chemotherapy in treatment of HER2-negative metastatic breast cancer(mBC).

NCT ID: NCT01915914 Completed - Skin Diseases Clinical Trials

A Randomized, Open-label, Comparative Study to Evaluate an Intermittent Dosing Regimen of Fluticasone Propionate 0.05% Cream (Twice Per Week) in Reducing the Risk of Relapse When Added to Regular Daily Moisturization Using PHYSIOGEL Lotion in Paediatric Subjects With Stabilized Atopic Dermatitis

Start date: December 23, 2013
Phase: Phase 4
Study type: Interventional

This is an open-label, randomized, comparative study, including 4 phases: SCREENING, ACUTE, MAINTENANCE and FOLLOW-UP. Subjects will complete the SCREENING phase to check the eligibility within 7 days after they sign the written informed consent form. All eligible subjects will be enrolled in ACUTE phase to receive twice daily Fluticasone propionate (FP) 0.05% cream up to 4 weeks. The efficacy and safety in ACUTE phase will be assessed every 2 weeks up to 4 weeks or until Treatment Success which depends on which time point comes first. Then subject can get into the MAINTENANCE phase receiving either emollient twice daily plus FP 0.05% cream once daily twice a week (Group A), or emollient twice daily (Group B), by 1:1 randomization. The treatment duration in MAINTENANCE phase will be up to 20 weeks. The efficacy and safety in MAINTENANCE phase will be assessed every 4 weeks up to 20 weeks or until AD relapse that depends on which time point comes first. If subjects don't experience relapse during MAINTENANCE phase, subsequent FOLLOW-UP phase applying emollient twice daily won't be longer than another 12 weeks. Total study duration is up to 37 weeks. All subjects receive FP 0.05% cream twice daily up to 4 weeks to all affected sites and any newly occurring sites in ACUTE phase. After randomization in MAINTENANCE phase, subjects either receive emollient twice daily extendedly plus FP 0.05% cream once daily twice a week to all healed sites and any newly occurring sites (Group A), or emollient twice daily extendedly (Group B), up to 20 weeks. In FOLLOW-UP phase, all subjects apply emollient twice daily up to 12 weeks. This study will enrol 120 subjects, and propose at least 80 subjects to be randomized. Study Endpoints/Assessments: Primary endpoint is to observe the median time to the first relapse of AD during MAINTENANCE phase. Secondary endpoints are: 1. Median time to the first relapse of AD during the whole study (including maintenance phase and follow-up phase. 2. Numbers of recurrent patients at the end of MAINTENANCE phase; 3. Numbers of recurrent patients at the end of FOLLOW-UP phase; 4. The effective rates (proportion of "treatment success" patients) during ACUTE phase (V3, W-2±2days;V4, W0±2days ) 5. Evaluate the safety during the whole study duration (ACUTE phase, MAINTENANCE phase, FOLLOW-UP phase respectively); 6. Evaluate visual skin assessment for signs of cutaneous atrophy, epidermal thickening / lichenification and abnormal pigmentation changes during the whole study duration (ACUTE phase, MAINTENANCE phase, FOLLOW-UP phase respectively); 7. The change of Quality of Life (QoL) from baseline at the end of MAINTENANCE phase; 8. The change of Quality of Life (QoL) from baseline at the end of FOLLOW-UP phase; 9. Subjects' post-study evaluation to drugs.

NCT ID: NCT01899287 Completed - Eczema Clinical Trials

A Randomised Clinical Trial on the Effect of Group Education on Patients With Occupational Hand Eczema

PREVEX
Start date: July 2012
Phase: N/A
Study type: Interventional

Occupational hand eczema (OHE) is a frequent disease which often takes a chronic course. The burden of the disease is high in a personal as well as in a socio-economic context. There is a need for evaluating new strategies to improve the prognosis for OHE patients. The objectives of the study is to evaluate the effect of group education on sick lave, health-related quality of life and disease severity among individuals with newly notified OHE. The trial population consist of individuals from the Capital Region of Denmark and Region Zealand with a suspected skin-related industrial injury notified to the Danish National Board of Industrial Injuries (DNBII). Recruitment is started Juli 2012, and will continue until the designed number of participants have been included. All participants will be assessed in a questionnaire at time T=0 with regard to: self evaluated disease severity, health-related quality of life, skin protective behaviour, knowledge of skin protection, self-efficacy, work-role function and if active in workforce. The participants will then be randomised. The intervention group will be invited to participate in the educative course, and work place visits will be offered. In the intervention group a telephone hot line will be available for further questions concerning these topics. The control group will not have access to any of these interventions. Both intervention group and control group will be contacted every eighth week about number of days of sick leave/absence from workforce. Both groups are re-assessed using a questionnaire at T=12 months. There will be a total of 742 included participants.

NCT ID: NCT01897675 Completed - Cutaneous Abscess Clinical Trials

A Comparison of Techniques for Treating Skin Abscesses

LoopDrainage
Start date: August 2013
Phase: N/A
Study type: Interventional

Management of abscesses traditionally involves incision and drainage (I&D). Abscesses are frequently are "packed" or stented open with the presence of a wick, and traditional care requires re-visits every 2-3 days to have the packing removed and replaced, until finally the abscess cavity has closed, usually 1-2 weeks after initial presentation. Recently there have been attempts to employ less invasive techniques for abscess management. One novel technique, "loop drainage", has been reported in case reports/case series for management of a variety of types of abscesses in the surgical subspecialty literature. We propose to conduct a randomized prospective study comparing the efficacy of the loop drainage technique with the traditional incision and drainage technique of abscess management. Patients presenting to the main or urgent care areas of the Emergency Department at Boston Medical Center for treatment of an abscess will be considered for enrollment as potential subjects. After the treating clinician identifies the patient as an appropriate subject, a Research Associate (RA) will approach the patient and obtain written informed consent to enroll in the study. The subject will then be randomized to the management arm of either loop drainage or traditional I&D. The clinician will fill out a data sheet describing the abscess characteristics, and then perform either loop drainage or incision and drainage, depending on randomization and the subject will fill out a satisfaction survey. Fourteen days after initial visit, subjects will return for follow-up. The subject will fill out a satisfaction survey, and a study investigator blinded to the treatment group will assess the subject for abscess resolution, cosmetic outcome, number of follow-up visits, and complications. The study investigators will then compare outcomes between the two study groups.

NCT ID: NCT01865032 Completed - Skin Diseases Clinical Trials

Evaluation of CL Detect™ Rapid Test to Detect Cutaneous Leishmaniasis

Start date: June 2013
Phase: N/A
Study type: Observational

This study is a single-site trial assessing the specificity of CL Detect™ Rapid Test versus the gold standard for Leishmania diagnosis in the US which is microscopic identification of Leishmania amastigotes in a stained lesion sample. Subjects will be patients who present for dermatology consultation with a primarily ulcerated lesion. After informed consent is obtained and the subject is screened for eligibility, 2 diagnostic samples will be collected from the subject's lesion in the following order: 1) one sample will be obtained with a dental broach for use with the CL Detect™ Rapid Test and 2) a second sample will be obtained by scraping for use in the microscopic identification of amastigotes. Samples will be analyzed by microscopy and CL Detect™ Rapid Test. The CL Detect™ Rapid Test will be performed by different operators who are clinical staff members. These staff members, blinded to each other's results, will evaluate the samples from each method independently. Each of the 150 study subjects will be followed administratively to the point where a diagnosis is established (if possible) for their tested lesion, even if that diagnosis is not cutaneous leishmaniasis (CL). If a specific diagnosis cannot be determined for a non-CL lesion, the investigator will assign a "likely etiology" (eg, infectious, oncological, immunological, vascular, or "undetermined/other" origin). Based on the diagnosis determined for each lesion, subjects will be referred for appropriate treatment.

NCT ID: NCT01791504 Completed - Clinical trials for Disorder of Skin and/or Subcutaneous Tissue of Trunk

Clinical Trial Comparing Standard Wound Closure Techniques Versus TissuGlu® Surgical Adhesive

Start date: March 2013
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to determine if TissuGlu® Surgical Adhesive is safe and effective alternative to drains(standard of care) for fluid management following abdominoplasty. It is hypothesized that the use of the Cohera device will facilitate reduction or closure of dead space when applied to planar surfaces created during an abdominoplasty procedure.

NCT ID: NCT01789905 Completed - Clinical trials for Intra-Abdominal Infections

Tygacil Drug Use Investigation

TIGER
Start date: April 15, 2013
Phase:
Study type: Observational

Secondary Data Collection Study; safety and effectiveness of Tigecycline .under Japanese medical practice