Efficacy Study of GLYC-101 to Evaluate Outcomes After Laser Ablation
Condition: Wounds
Intervention: GLYC-101 Gel (0.1%); GLYC-101 Gel (1.0%); GLYC-101 Placebo
Intervention description: Topical administration to the laser-ablated area on days 1 (day of laser ablation), 2, 3, 4, and 5.; Topical administration to the laser-ablated area on days 1 (day of laser ablation), 2, 3, 4, and 5.; Topical administration to the laser-ablated area on days 1 (day of laser ablation), 2, 3, 4, and 5.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 26.0
Sex: All
Minimum age: 25 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: burn wounds; wound healing

Summary:

      The primary objectives of this study are to evaluate safety and efficacy of topically applied
      Glucoprime gel (GLYC-101, 0.1% and GLYC-101, 1.0%) in promoting wound healing in cosmetic
      surgery patients undergoing Carbon Dioxide Laser Skin Resurfacing (CO2 LSR) of the lower
      eyelids. The study will observe the effects of the topical agent over the course of 1 month
      following the initial treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female healthy volunteer subjects, between 25 and 70 years of age, giving
             informed consent for facial laser ablation of the lower eyelid areas for the purpose
             of wrinkle removal.

          -  Lower eyelid skin is free of any irritation, scarring or dermatologic conditions which
             might interfere with the study.

          -  Willing and able to participate in the study and follow all study directions.

          -  Able to read, understand and sign the consent form prior to any study related
             procedures.

        Exclusion Criteria:

          -  Female subjects who are pregnant, nursing, or planning a pregnancy during the course
             of the study, as determined by the interview and a urine pregnancy test.

          -  Presence of irritation or dermatologic skin conditions in the lower eyelid area.

          -  Known allergies to materials within the test formulations (i.e., yeast and/or yeast
             products).

          -  Use of topical or systemic drugs (corticosteroids, retinoids, immune modulators,
             immune suppressants, drugs with potential for contact dermatitis, drugs with potential
             for skin discoloration) that may have an effect on wound healing or may impact skin
             pigmentation.

          -  A history, upon wounding, of developing thickened scars, keloids, or excessive pigment
             change.

          -  An unstable or severe inter-current medical condition that, in the opinion of the
             investigator, might interfere with interpretation of study results or render the
             subject at high risk for treatment complications.

          -  Use of any investigational medication or device for any indication within 30 days of
             screening.