About this trial
The primary objective of this study is to evaluate the efficacy and tolerability of Pavise Extracellular Matrix Restore (ECMR), compared with standard acute post-operative care, when used as the primary occlusive treatment immediately following ablative CO₂ and Er:YAG facial laser resurfacing to support wound healing.
Eligibility criteria
Qualifiers
Males or females in good general health age 35-70 years of age.
Subjects with score Moderate to Severe (Class II-III, Score 4-9) on the Fitzpatrick-Goldman Classification of Wrinkling and Degree of Elastosis Scale (Appendix E)
Subjects with score Moderate to Severe facial photodamage as assessed by the Modified Griffth's Scale (Appendix F)
Fitzpatrick skin types I-III.
Disqualifiers
Pregnant, planning to become pregnant during the course of the study, or breastfeeding.
Prescence of an active bacterial, fungal, or viral infection in the treatment area.
Significant history or current evidence of a medical, psychological or other condition that, in the investigator's opinion, would preclude enrollment into the study.
Use of any topical products containing tretinoins or derivatives, alpha-hydroxy acids, salicylic acid, and vitamins C or E (includes derivatives thereof) on the face within 14 days prior to or during the study period, other than the study products.
Trial design
Treatments tested in this trial
- Pavise Serum
- Sham Comparator
- Co2/Er:YAG
Treatment groups
Locations
Sponsors and collaborators
Goldman, Butterwick, Fitzpatrick and Groff
Lead sponsor
Bai Biosciences
Collaborator