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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

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:

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.

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

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

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

NCT ID

NCT04844840

First Posted

April 8, 2021

Last Updated

February 28, 2023

Sponsor

Sirnaomics

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

Data Monitoring Committee

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

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

Learn more about this trial

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

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