A Study for Safety and Efficacy Evaluation of Various Doses of STP705 in Reducing Keloid Recurrence

A Phase 2, Multi-Center, Randomized, Multiple Arm, Controlled Pilot Study to Evaluate the Safety and Efficacy of Various Doses of STP705 in Reducing Post- Keloidectomy Keloid Recurrence

Phase 2, randomized, double-blind, multiple arm, controlled study to evaluate safety & efficacy of various doses of STP705 in reducing post Keloidectomy keloid recurrence.

Study Overview

• Status: Completed
• Conditions: Keloid
• Intervention / Treatment: Other: Placebo; Drug: STP705

Detailed Description

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
• Enrollment (Actual): 29
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85255
      • Investigate MD
  • Florida
    • Aventura, Florida, United States, 33180
      • Center for Clinical and Cosmetic Research
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Schweiger Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female ≥18 years of age, inclusive having at least one keloid scar.
2. Female subjects of child-bearing potential must agree to the use of an effective method(s) of contraception beginning at or before the screening visit until one month after administration of the final study dose. For the purposes of the protocol, highly effective method(s) of contraception will be defined as consistently and correctly used implants, injectables, combined oral contraceptives, sexual abstinence or a vasectomized partner.
3. The 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/-facial/-scalp), measures ≥0.30cm2, and be suitable for surgical excision which will result in a single wound no greater than 7cm long.
4. Able and willing to give written informed consent.
5. Willing to comply with the follow up schedule for 12 months.
6. Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, or vital sign abnormalities as deemed by the PI.

Exclusion Criteria:

1. Prior treatment of the keloid scar in the previous 6 weeks.
2. The keloid scar must not have undergone prior surgical excisions (laser, cryotherapy or surgery).
3. The keloid scar must not have undergone prior radiation treatment.
4. Pregnant, lactating, or planning to become pregnant during the course of the study.
5. Advanced or poorly controlled diabetes.
6. Active local infection at the treatment site and/or systemic infection that would in the opinion of the Investigator affect the treatment site.
7. Any medical or surgical condition that will interfere with required study activities or assessments or that make the study treatments contraindicated in the opinion of the study Investigator.
8. Unwilling to refrain from use of any other scar treatment therapy/scar improving product, during the study.
9. Regular, continuous use of systemic corticosteroid therapy or topical corticosteroid use in the area to be treated.
10. Current participation or participation within the last 1 months in the study of an investigational drug, device, or biologic.
11. Unable or unwilling to follow post-operative instructions.
12. Mentally or legally incapacitated or has significant emotional problems at the time of screening visit or expected during the conduct of the study.
13. History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds, or drug product excipients.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1: STP705 10 μg dose; STP705 at the assigned dose will be injected intradermal into the excised keloid site	Drug: STP705; STP705 is composed of two siRNA oligonucleotides, targeting TGF-β1 and COX-2 mRNA, respectively; Other Names: STP705 Powder for Injection
Experimental: Cohort 2: STP705 20 μg dose; STP705 at the assigned dose will be injected intradermal into the excised keloid site	Drug: STP705; STP705 is composed of two siRNA oligonucleotides, targeting TGF-β1 and COX-2 mRNA, respectively; Other Names: STP705 Powder for Injection
Experimental: Cohort 3: STP705 30 μg dose; STP705 at the assigned dose will be injected intradermal into the excised keloid site	Drug: STP705; STP705 is composed of two siRNA oligonucleotides, targeting TGF-β1 and COX-2 mRNA, respectively; Other Names: STP705 Powder for Injection
Experimental: Cohort 4: STP705 40 μg dose; STP705 at the assigned dose will be injected intradermal into the excised keloid site	Drug: STP705; STP705 is composed of two siRNA oligonucleotides, targeting TGF-β1 and COX-2 mRNA, respectively; Other Names: STP705 Powder for Injection
Placebo Comparator: Cohort 5: Placebo control; Placebo (saline) will be injected intradermal into the excised keloid site	Other: Placebo; Saline
No Intervention: Cohort 6: SOC alone; SOC (no injection)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Recurrence	Rate of recurrence in subjects undergone surgery alone (with or without placebo) vs surgery and STP705	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Keloid size	Change of Keloid scar appearance from baseline evaluated by caliper	12 months
Change of Keloid scar appearance	Change of Keloid scar appearance from baseline evaluated by POSAS	12 months
Change of Keloid volume/size	Change in size of post excision keloid from baseline by volumetric measurements using quantitative imaging	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).	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.	12 months

Collaborators and Investigators

• Sponsor: Sirnaomics
• Investigators: Principal Investigator: Mark Nestor, MD, Center for Clinical and Cosmetic Research; Principal Investigator: David Goldberg, MD, Schweiger Dermatology Group; Principal Investigator: Brenda LaTowsky, MD, Investigate MD

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2021
• Primary Completion (Actual): May 17, 2023
• Study Completion (Actual): May 17, 2023

Study Registration Dates

• First Submitted: April 8, 2021
• First Submitted That Met QC Criteria: April 12, 2021
• First Posted (Actual): April 14, 2021

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Connective Tissue Diseases; Fibrosis; Cicatrix; Collagen Diseases; Recurrence; Keloid
• Other Study ID Numbers: SRN-705-007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No