The purposes of this study is to test the safety of the study drug (FSR peptide) after a punch biopsy in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
49
Administered immediately after punch-biopsy and 24 hours after punch biopsy.
Administered immediately after punch-biopsy and 24 hours after punch biopsy.
Administered immediately after punch-biopsy and 24 hours after punch biopsy.
Swiss Pharma Contract Ltd
Allschwil, Switzerland
Frequency of adverse events
Time frame: Time of consent to day 28
Time to healing
The wound was clinically evaluated as healed or not healed.
Time frame: Up to 28 days
Presence of hypertrophic granulation tissue
Clinically assessed as present or not present. To qualify as present, there should be at least 3 mm granulation tissue protruding above the edge of the wound at any point of its perimeter.
Time frame: Up to 28 days
Clinical General Impression scale on the evolution of the wound.
Scale of 1-5: 1- Very bad; 2- Bad; 3- Fair; 4- Good; 5- Very Good
Time frame: Up to 28 days
Wound height
Assessed using the abbreviated Vancouver Scar Scale. The resulting abbreviated score was as follows. Scores are combined to calculate the final score. Pigmentation 0- Normal. Color that closely resembles the color over the rest of the subject's body 1. Hypopigmentation 2. Hyperpigmentation Vascularity 0- Normal. Color that closely resembles the color over the rest of the subject's body 1. Pink 2. Red 3. Purple
Time frame: day 28
Wound pliability
Assessed using the abbreviated Vancouver Scar Scale. The resulting abbreviated score was as follows. Scores are combined to calculate the final score. Pigmentation 0- Normal. Color that closely resembles the color over the rest of the subject's body 1. Hypopigmentation 2. Hyperpigmentation Vascularity 0- Normal. Color that closely resembles the color over the rest of the subject's body 1. Pink 2. Red 3. Purple
Time frame: day 28
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Administered immediately after punch-biopsy and 24 hours after punch biopsy.
Administered immediately after punch-biopsy and 24 hours after punch biopsy.
Histopathological evaluation of the area of the scar tissue
Performed in a punch biopsy taken from the initial wound site at the end of the 28 day evaluation period.
Time frame: day 28
Histopathological evaluation of the epidermal involution
Performed in a punch biopsy taken from the initial wound site at the end of the 28 day evaluation period.
Time frame: day 28
Histopathological evaluation of the rete pegs
Performed in a punch biopsy taken from the initial wound site at the end of the 28 day evaluation period.
Time frame: day 28
Histopathological evaluation of the area of granulation tissue
Performed in a punch biopsy taken from the initial wound site at the end of the 28 day evaluation period.
Time frame: day 28