Comparative Study of Two Topical Anesthetics Prior to Fractional Nonablative Laser Treatment of the Face

Overview

About this study

The purpose of this study is to evaluate the amount of pain (10 point VAS score for pain), burning, and itching that patients experience during a procedure by cosmetic dermatologists to numb the skin prior to laser procedures.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Male or female in general good health, 18 years of age or older.
  • Undergoing fraxel laser treatment.
  • Fitzpatrick skin type I-IV with at least mild photodamage of the face by physician discretion.
  • Subject has completed an appropriately administered informed consent process which includes signing the IRB approved consent form.
  • Willingness to have facial exams and digital photos performed of the face.
  • Female patients will be either of non-childbearing potential defined as:
    • Having no uterus;
    • No menses for at least 12 months; or
  • Women of childbearing potential (WOCBP) must agree to use an effective method of birth control during the course of the study, such as:
    • Oral contraceptive pill, injection, implant, patch, vaginal ring, intrauterine device;
    • Intrauterine coil;
    • Bilateral tubal ligation;
    • Barrier method used with an additional form of contraception (e.g., sponge, spermicide or condom);
    • Abstinence (if practicing abstinence must agree to use barrier method described above if becomes sexually active);
    • Vasectomized partner (Must agree to use barrier method described above if becomes sexually active with non-vasectomized).

Exclusion Criteria:

  • Presence of incompletely healed wound or active skin disease within in treatment area.
  • Pregnant, planning pregnancy or breastfeeding during the course of the study.
  • Individuals who have ablative laser within 6 months; non ablative lasers, facial peels, or dermabrasion within 1 month.
  • Individuals with known allergies or sensitivities to any of the ingredients of any topical products being used in this study (a list of the products with active and excipients will be provided below).
  • Subjects with any pre-existing medical or psychological condition which, in the opinion of the investigator, would put them at increased risk due to study treatment or participation.
  • Subjects who are unable to comprehend the study consent document or provide full written consent.
  • Subjects who have taken isotretinoin within 3 months or systemic corticosteroids within 1 month.
  • Subjects with history of severe cardiovascular disease, kidney disease, liver disease, uncontrolled diabetes, uncontrolled seizures, immunosuppression.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Elika Hoss, M.D.

Open for enrollment

Contact information:

Elika Hoss M.D.

(480) 301-6479

Hoss.Elika@mayo.edu

More information

Publications

Publications are currently not available