Dose Regimen Study of SLI-F06 in Healthy Volunteers
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorScarless Laboratories, Inc.
About this trial
Multi-center, dose-regimen, double-blind study evaluating the safety and efficacy of 4 doses of SLI-F06 compared with vehicle for improvement in scar appearance
Eligibility criteria
Qualifiers
Healthy subjects, male or female, ages 18 to 65
Subjects with a Body Mass Index (BMI) 18.5-30 and at least 40 kg
Subjects with symmetrically located right and left scapular lines relative to the midline, and at least 12 cm distance between the right and left scapular lines.
Be able to follow study instructions and likely to complete all required visits.
Disqualifiers
Female subjects who are pregnant, breast-feeding, or of childbearing potential and not practicing reliable birth control methods
Subjects who were previously treated with SLI-F06
Subjects with evidence of hypertrophic or keloid scarring
Subjects with obvious back abnormalities (e.g., severe scoliosis)
Trial design
Treatments tested in this trial
- SLI-F06
Treatment groups
30 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov