Phase 2, randomized, double-blind, multiple arm, controlled study to evaluate safety \& efficacy of various doses of STP705 in reducing post Keloidectomy keloid recurrence.
The objective of this study isto assess the safety, tolerability, and efficacy of various doses of STP705 and placebo via intradermal injection into the keloid excision site, to prevent the recurrence of keloids following their excision. A total of up to 60 adult subjects will be enrolled. One eligible qualifying keloid will be excised. The subjects will be randomized to receive STP705, placebo or SOC alone (no injection) for treatment of the keloidectomy excision suture line. To be eligible, keloid scar(s) must have been present for at least one year with a target keloid area on the trunk or extremity (non-peri-orbital/-anogenital/-scalp), measures ≥0.30cm2, and be suitable for surgical excision which will result in a single wound no greater than 7cm long. The study is divided into 3 phase: screening phase (4 weeks), Treatment phase (up to 4 weeks +/- allowed windows), Follow up phase (up to 52 weeks +/- allowed windows).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
29
Investigate MD
Scottsdale, Arizona, United States
Center for Clinical and Cosmetic Research
Aventura, Florida, United States
Schweiger Dermatology
Hackensack, New Jersey, United States
Rate of Recurrence
Rate of recurrence in subjects undergone surgery alone (with or without placebo) vs surgery and STP705
Time frame: 12 months
Change of Keloid volume/size
Change in size of post excision keloid from baseline by volumetric measurements using quantitative imaging
Time frame: 12 months
Change of Keloid size
Change of Keloid scar appearance from baseline evaluated by caliper
Time frame: 12 months
Change of Keloid scar appearance
Change of Keloid scar appearance from baseline evaluated by POSAS
Time frame: 12 months
Change in DLQI score
The Dermatology Life Quality Index (DLQI) is a self-reported 10-item questionnaire assessing the impact of skin disease on the patient over the previous week. The items cover symptoms, treatment, activity limitations, and emotional reactions to having a skin disease. Nine items have four response options: "Not at all", "A little", "A lot", and "Very much", whereas item 7 first asks whether work or study has been prevented and then (if "No") to what degree the skin condition has been a problem at work/study ("A lot", "A little", or "Not at all"). Eight of the items also have a "Not relevant" option that is scored "0", indicating no problem. Individual item scores are summed to derive a total DLQI score that can range from 0 to 30, with higher scores indicating worse health- related quality of life (HRQL).
Time frame: 12 months
Change in mVSS score
The modified Vancouver Scar Scale (mVSS) performs a comprehensive measurement rating characteristic of pigmentation, vascularity, pliability, and height. For each subject, a total Vancouver score was determined by summing the scores of the four individual parameters to generate a score ranging from 0 to 15 points, with higher scores indicating worse score severity.
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Time frame: 12 months