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A single site, double-blind, randomized, placebo-controlled, clinical study comparing the difference between a novel healing gel and a placebo gel on post laser-resurfacing chests.
Full description
This is a double-blind, randomized, placebo-controlled, chest clinical study with a single study site. Forty subjects will receive fractionated CO2 laser resurfacing of the chest. . Immediately following the procedure (Day 0), postoperative gel randomized to the chest (TR-987 or placebo), will be applied with a thickness of 1-2 mm by a non-blinded coordinator, along with a split-chest Silon TSR bandage. Subjects will return for follow up on Day 1, with the gel and split chest Silon TSR© bandages applied by non-blinded coordinator during visit, with further follow-up on Days 6, 8, 10, 13 and 28. Both subjects and evaluating investigator will be blinded to randomization schedule (performed by an unblinded coordinator). Subject will apply gels and split chest Silon TSR© bandages at home on Days 2, 3 and 4 when not visiting clinic.
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Inclusion criteria
Females or males in good general health greater than 18 years of age.
Must be willing to give and sign a HIPPA form, informed consent form, and a photographic release form
Subject is planning to undergo fractionated CO2 laser resurfacing to the chest
A potential subject's must exhibit:
--Skin phototype of Fitzpatrick Type I-IV
For FEMALE SUBJECT OF CHILDBEARING POTENTIAL, must have had a regular menstrual cycle prior to study entry (a female is considered of childbearing potential unless she is postmenopausal, without a uterus and/or both ovaries, or has had a bilateral tubal ligation) and is willing to use an acceptable form of birth control during the entire course of the study [i.e., acceptable methods of birth control are oral contraceptives, contraceptive patches/rings/implants Norplant®, Depo-Provera®, double-barrier methods (e.g. condoms and spermicide), abstinence and vasectomies of partner with a documented second acceptable method of birth control should the subject become sexually active]. All systemic birth control measures must be in consistent use at least 30 days prior to study participation. Postmenopausal is defined as having the last menstrual cycle in at least 12 months
Negative urine pregnancy test results at the time of study entry (if applicable)
Must be willing to comply with study dosing and complete the entire course of the study.
Exclusion criteria
Primary purpose
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Interventional model
Masking
17 participants in 4 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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