Erythematotelangiectatic Rosacea Clinical Trial
Official title:
Feasibility Study: Evaluation of the Effectiveness and Safety of the Ulthera® System for Treatment of Erythematotelangiectatic Rosacea
Verified date | November 2013 |
Source | Merz Pharmaceuticals, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Up to 12 subjects will be enrolled. Enrolled subjects will receive one or two Ultherapy treatments on the cheeks, depending on their assigned study group. Follow-up visits will occur 14, 30 and 90 days post-treatment. Study images will be obtained pre-treatment, 30-60 min post-treatment, and at each follow-up visit.
Status | Completed |
Enrollment | 12 |
Est. completion date | October 2013 |
Est. primary completion date | May 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Male or female, aged 18 to 65 years. - Subject in good health. - Clinical diagnosis of Erythematotelangiectatic Rosacea. - Understands and accepts the obligation not to undergo any other procedures in the area(s) to be treated through the follow-up period. - Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study. - Absence of physical or psychological conditions unacceptable to the investigator. - Willingness and ability to provide written consent for study-required photography and adherence to photography requirements. - Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedure. - Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at Visit 1. Exclusion Criteria: - Presence of an active systemic disease that may affect wound healing. - Prominent telangiectases in the area(s) to be treated. - History of post-inflammatory hyperpigmentation. - Papulopustular or Phymatous Rosacea. - Severe solar elastosis. - Significant scarring in area(s) to be treated. - Open wounds or lesions in the area(s) to be treated. - Severe or cystic acne on the area(s) to be treated. - Presence of a metal stent or implant in the area(s) to be treated. - Inability to understand the protocol or to give informed consent. - Microdermabrasion, or prescription level glycolic acid treatments to the intended treatment area(s) within six weeks prior to study participation or during the study. - Marked asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin in the area(s) to be treated. - History of chronic drug or alcohol abuse. - History of autoimmune disease. - Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study device. - Subjects who anticipate the need for surgery or overnight hospitalization during the study. - Subjects who, in the investigator's opinion, have a history of poor cooperation,noncompliance with medical treatment, or unreliability. - Concurrent enrollment in any study involving the use of investigational devices or drugs. - Current smoker or history of smoking in the last five years. - History of the following cosmetic treatments in the area(s) to be treated: 1. Skin tightening procedure within the past year; 2. Injectable filler of any type within the past: - 12 months for Hyaluronic acid fillers (e.g.,Restylane) - 12 months for Ca Hydroxyapatite fillers (e.g., Radiesse) - 24 months for Poly-L-Lactic acid fillers (e.g., Sculptra) - Ever for permanent fillers (e.g., Silicone, ArteFill) 3. Neurotoxins within the past three months; 4. Ablative resurfacing laser treatment; 5. Nonablative, rejuvenative laser or light treatment within the past six months; 6. Surgical dermabrasion or deep facial peels - History of using the following prescription medications: 1. Accutane or other systemic retinoids within the past six months; 2. Topical Retinoids within the past two weeks; 3. Antiplatelet agents / Anticoagulants (Coumadin, Heparin, Plavix); 4. Psychiatric drugs that in the investigators opinion would impair the subject from understanding the protocol requirements or understanding and signing informed consent. |
Country | Name | City | State |
---|---|---|---|
Canada | Cosmedica | Victoria | British Columbia |
Lead Sponsor | Collaborator |
---|---|
Ulthera, Inc |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Improvement in Erythematotelangiectatic Rosacea of treatment area versus control | As determined by Primary Investigator assessment | 90-days post-treatment treatment | |
Secondary | Improvement in Erythematotelangiectatic Rosacea of treatment area versus control (untreated area) | As determined by a live patient assessment and investigator designation of improved versus not improved for the area treated compared to the surrounding area at follow-up in Phase I | Participants will be followed for 90-days post treatment #1 (Group A) or post-treatment #2 (Group B) |
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