Pulsed Dye Laser Treatment and Oxymetazoline Hydrochloride (HCL) 1% Cream for Erythematotelangiec… (NCT04153188) | Clinical Trial Compass
CompletedPhase 4
Pulsed Dye Laser Treatment and Oxymetazoline Hydrochloride (HCL) 1% Cream for Erythematotelangiectatic Rosacea
United States34 participantsStarted 2019-01-15
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Subject is a healthy male or female of 18 to 75 years of age.
✓. Subject has erythematotelangiectatic rosacea with clinician erythema assessment (CEA) and subject self-assessment (SSA) of "moderate" or "severe" (Grade 3 or 4).
✓. Fitzpatrick Skin Type I - VI.
✓. Subject must be able to read, understand and sign the Informed Consent Form.
✓. Subject must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions.
✓. Subject must be willing to have limited sun exposure for the duration of the study, including the follow-up period up to 6 months post-baseline.
✓. Subject is willing to have photographs taken of the treated area that will be used, de-identified, in evaluations and may be used, de-identified, in presentations and/or publications.
✓. For female candidates - subject must be post-menopausal, or surgically sterilized, or using a medically acceptable form of birth control during the entire course of the study.
Exclusion criteria
✕. Subject is pregnant or planning to become pregnant during the study duration.
✕. Subject has an active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
✕. Subject has an implant in the treated area (such as metal plates or screws) or an injected chemical substance.
What they're measuring
1
Clinical Erythema Assessment (CEA) Score At 6-Month Post-Baseline
✕. Subject has a known collagen (connective tissue) disorder, vascular disease, scleroderma or other autoimmune disease (i.e. rheumatoid arthritis, lupus).
✕. Subject has a history of diseases stimulated by heat or sun exposure, such as recurrent Herpes Simplex in the treated area, unless treatment is conducted following a prophylactic regimen.
✕. Subject has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.
✕. Having or undergoing any form of treatment for active cancer or having a history of skin cancer or any other cancer in the areas to be treated, including presence of malignant or pre-malignant pigmented lesions.
✕. Subject is suffering from significant concurrent illness, such as such as cardiac disorders, diabetes (type I or II), or pertinent neurological disorders.