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

Primary Purpose

Keloid

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
STP705
Placebo
Sponsored by
Sirnaomics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keloid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • MD Investigate
  • Center for Clinical and Cosmetic Research
  • Schweiger Dermatology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

No Intervention

Arm Label

Cohort 1: STP705 10 μg dose

Cohort 2: STP705 20 μg dose

Cohort 3: STP705 30 μg dose

Cohort 4: STP705 40 μg dose

Cohort 5: Placebo control

Cohort 6: SOC alone

Arm Description

STP705 at the assigned dose will be injected intradermal into the excised keloid site

STP705 at the assigned dose will be injected intradermal into the excised keloid site

STP705 at the assigned dose will be injected intradermal into the excised keloid site

STP705 at the assigned dose will be injected intradermal into the excised keloid site

Placebo (saline) will be injected intradermal into the excised keloid site

SOC (no injection)

Outcomes

Primary Outcome Measures

Rate of Recurrence
Rate of recurrence in subjects undergone surgery alone (with or without placebo) vs surgery and STP705

Secondary Outcome Measures

Change of Keloid volume/size
Change in size of post excision keloid from baseline by volumetric measurements
Change of Keloid size
Change of Keloid scar appearance from baseline evaluated by caliper
Change of Keloid scar appearance
Change of Keloid scar appearance from baseline evaluated by POSAS
Change in DLQI
Change in VSS score

Full Information

First Posted
April 8, 2021
Last Updated
February 28, 2023
Sponsor
Sirnaomics
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1. Study Identification

Unique Protocol Identification Number
NCT04844840
Brief Title
A Study for Safety and Efficacy Evaluation of Various Doses of STP705 in Reducing Keloid Recurrence
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 29, 2021 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sirnaomics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keloid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
10 subjects each will be randomly allocated to either the assigned STP705 treatment group, placebo or SOC alone in a 1:1:1:1:1:1 ratio. An individual, independent of the clinical trial team, will develop the randomization schedules. The actual randomization assignment will be prepared through a web-based system. STP705 or placebo will be injected intradermally at the keloid excision site.
Masking
ParticipantInvestigator
Masking Description
This is a double-blind study. All subjects, investigator, and site staff (except unblinded pharmacist or designated site staff) in the study will be blinded to the treatment assignment.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1: STP705 10 μg dose
Arm Type
Experimental
Arm Description
STP705 at the assigned dose will be injected intradermal into the excised keloid site
Arm Title
Cohort 2: STP705 20 μg dose
Arm Type
Experimental
Arm Description
STP705 at the assigned dose will be injected intradermal into the excised keloid site
Arm Title
Cohort 3: STP705 30 μg dose
Arm Type
Experimental
Arm Description
STP705 at the assigned dose will be injected intradermal into the excised keloid site
Arm Title
Cohort 4: STP705 40 μg dose
Arm Type
Experimental
Arm Description
STP705 at the assigned dose will be injected intradermal into the excised keloid site
Arm Title
Cohort 5: Placebo control
Arm Type
Placebo Comparator
Arm Description
Placebo (saline) will be injected intradermal into the excised keloid site
Arm Title
Cohort 6: SOC alone
Arm Type
No Intervention
Arm Description
SOC (no injection)
Intervention Type
Drug
Intervention Name(s)
STP705
Intervention Description
STP705 is composed of two siRNA oligonucleotides, targeting TGF-β1 and COX-2 mRNA, respectively
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Saline
Primary Outcome Measure Information:
Title
Rate of Recurrence
Description
Rate of recurrence in subjects undergone surgery alone (with or without placebo) vs surgery and STP705
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change of Keloid volume/size
Description
Change in size of post excision keloid from baseline by volumetric measurements
Time Frame
12 months
Title
Change of Keloid size
Description
Change of Keloid scar appearance from baseline evaluated by caliper
Time Frame
12 months
Title
Change of Keloid scar appearance
Description
Change of Keloid scar appearance from baseline evaluated by POSAS
Time Frame
12 months
Title
Change in DLQI
Time Frame
12 months
Title
Change in VSS score
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female ≥18 years of age, inclusive having at least one keloid scar. 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. 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. Able and willing to give written informed consent. Willing to comply with the follow up schedule for 12 months. Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, or vital sign abnormalities as deemed by the PI. Exclusion Criteria: Prior treatment of the keloid scar in the previous 6 weeks. The keloid scar must not have undergone prior surgical excisions (laser, cryotherapy or surgery). The keloid scar must not have undergone prior radiation treatment. Pregnant, lactating, or planning to become pregnant during the course of the study. Advanced or poorly controlled diabetes. Active local infection at the treatment site and/or systemic infection that would in the opinion of the Investigator affect the treatment site. 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. Unwilling to refrain from use of any other scar treatment therapy/scar improving product, during the study. Regular, continuous use of systemic corticosteroid therapy or topical corticosteroid use in the area to be treated. Current participation or participation within the last 1 months in the study of an investigational drug, device, or biologic. Unable or unwilling to follow post-operative instructions. Mentally or legally incapacitated or has significant emotional problems at the time of screening visit or expected during the conduct of the study. History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds, or drug product excipients.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nadia Sheibani
Organizational Affiliation
Director, Clinical Operations
Official's Role
Study Director
Facility Information:
Facility Name
MD Investigate
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85255
Country
United States
Facility Name
Center for Clinical and Cosmetic Research
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Schweiger Dermatology
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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