Treatment Trials

11 Clinical Trials for Various Conditions

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COMPLETED
Pulsed Dye Laser Treatment and Oxymetazoline Hydrochloride (HCL) 1% Cream for Erythematotelangiectatic Rosacea
Description

This study will compare treatment outcome with pulsed dye laser, when used used as an adjunctive treatment to oxymetazoline HCl 1% cream, compared to oxymetazoline HCL 1% cream alone, for patients with moderate or severe erythematotelangiectatic rosacea.

COMPLETED
Excel V 532 nm KTP Laser for Treatment of Erythematotelangiectatic Rosacea & Papulopustular Rosacea
Description

A single center prospective, randomized, controlled split face study comparing a 532nm KTP laser with a 595nm PDL for the treatment of Erythematotelangiectatic Rosacea and Papulopustular Rosacea. Subjects will receive laser treatments and will be followed at 6 weeks post-final laser treatment.

COMPLETED
Ultherapy® for the Treatment of Erythematotelangiectatic Rosacea
Description

This is a prospective, multi-site (up to 5 sites), single-blinded, randomized trial. Up to 88 subjects will be enrolled and randomized to one of four treatment groups (4 Groups of 22 subjects), and will receive study treatments based on their assigned treatment group. Following study treatments, follow-up visits will occur at 90, 180 and 365 days from each subject's last study treatment.

COMPLETED
Dose-Finding Study of CD07805/47 Topical Gel in Subjects With Erythematotelangiectatic Rosacea
Description

This is a randomized, double-blind, parallel-group, vehicle-controlled, dose-finding study to investigate the pharmacodynamics and the safety of three dosages of CD07805/47 topical gel (0.07%, 0.18%, and 0.50%), after a single application in subjects with a clinical diagnosis of stable moderate to severe erythematotelangiectatic rosacea. Subjects will be randomized in a 1:1:1:1 ratio to receive either one of three CD07805/47 topical gel concentrations (0.07%, 0.18%, or 0.50%) or Vehicle Gel. All subjects will be treated with a single application (once daily dosing for one day) of study medication.

COMPLETED
Open Label Pilot Study of Apremilast in Treatment of Rosacea
Description

Rosacea is a chronic skin disorder with the signs and symptoms of facial flushing, persistent redness, small visible spider-like veins, papules (inflamed red bumps under the skin) and pustules. Rosacea is also a a recurring skin disorder. In addition to causing uncomfortable and embarrassing physical symptoms such as flushing, burning, and itching, rosacea can also contribute to lower self-esteem, which can have a significant psychosocial impact on quality of life. Rosacea flares can be triggered by every day factors such as sun exposure, heat, hot or caffeinated drinks, alcoholic beverages, spices and stress. Many of the currently available treatments for rosacea are only partially effective and some patients do not respond to them, or are unable to tolerate the side effects. This is a single-center, open label trial of Apremilast in ten (10) subjects with moderate to severe inflammatory rosacea who will be treated with Apremilast 20 mg twice per day for 12 weeks. Following the screening period and baseline visit, study subjects will return at weeks 1, 2, 4, 6, 8, 10 and 12. There is a follow up study visit at week 16. Recent research has shown an increase of specific proinflammatory cytokines in the biopsies of inflammatory lesions from rosacea and acne patients. The cytokines then trigger a chain of chemical responses in the body that likely result in the development of the papules an pustules that are seen in rosacea and acne patients. Apremilast is an oral agent that modulates multiple anti-inflammatory pathways and has pharmacodynamic properties with potential therapeutic benefit for treating inflammatory autoimmune disorders. The investigators therefore propose a pilot study to evaluate the potential for Apremilast to improve the signs and symptoms of moderate to severe inflammatory rosacea.

COMPLETED
Combination Therapy for the Treatment of Rosacea
Description

The purpose of this study is to determine the efficacy of calcium dobesilate in combination with pulsed dye laser for the treatment of rosacea.

COMPLETED
A Therapeutic Equivalence Study of Two Metronidazole Gel 1% Topical Treatments of Rosacea
Description

The purpose of this study is to compare the efficacy of two Metronidazole Gels 1%, in the treatment of Rosacea.

COMPLETED
A Study to Determine Safety and Efficacy of B244 in Subjects With Mild to Moderate Rosacea
Description

This is a Prospective, Vehicle Controlled, Double Blind, Multicenter, Randomized Phase II trial, comparing the effect of twice daily B244 application for 8 weeks vs. vehicle application on treatment of mild to moderate rosacea.

Conditions
RECRUITING
Metronidazole SC Penetrance With Moisturizers
Description

Topical metronidazole is a widely used first line treatment for erythemotelangiectatic and inflammatory rosacea. Commonly, a moisturizer is also used to restore the skin barrier and reduce inflammation. The purpose of this study is to assess the whether the common practice of applying moisturizer prior to topical metronidazole affects this medication's stratum corneum penetrance in rosacea patients. Participants will have one research office visit that will consist of having a randomly assigned combination of metronidazole and one of four moisturizers applied to their face, followed by non-invasive tape stripping of skin at the 1 hour and 4 hour time points. These tape strip samples will be analyzed with liquid chromatography mass spectrometry (LC-MS) for assessment of metronidazole penetrance in the stratum corneum in the presence of moisturizers. The target population will be rosacea patients in the age range of 18-60 years of age. This study has minimal risks/safety issues as topical metronidazole is an already FDA approved medication with an indication for rosacea and all investigated moisturizers are over-the-counter formulations commonly used within the rosacea patient population. Tape stripping will remove 5 levels of superficial stratum corneum, and will not result in bleeding, scarring, or other prolonged cosmetic disfigurement. Small, transient bruising may result from tape strip collection. The collected samples will have no to minimal biohazard risk, as the collected specimen for analysis will only contain skin scale; samples will be extracted with organic solvents and decontaminated with a 0.2 micron nylon filter prior to analysis on the LC-MS instrumentation.

COMPLETED
Topical Mitogenic-Activated Protein Kinase (MAPK) Inhibition in Rosacea
Description

This is a prospective, vehicle controlled, double blinded study to evaluate the safety and potential efficacy of a topical formulation of a MEK inhibitor in patients with erythematotelangiectatic rosacea

RECRUITING
Rosacea Radiofrequency Microneedling
Description

There are 3 main objectives of this proposal as follows: (1) to assess the efficacy of radiofrequency microneedling in the treatment of erythematotelangiectatic and or papulopustular rosacea, (2) to determine the potential for combination treatment of radiofrequency microneedling with the 532 nm KTP laser, and (3) identify potential novel therapeutic strategies for the treatment of rosacea.