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

NCT04844840 | Completed Phase 2 FDA Drug

• 1 other identifier: SRN-705-007
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 3

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.

Conditions

Keloid

Outcome Measures

Primary Outcomes (1)

• Rate of Recurrence

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

  12 months

Secondary Outcomes (5)

• Change of Keloid volume/size

  12 months

• Change of Keloid size

  12 months

• Change of Keloid scar appearance

  12 months

• Change in DLQI score

  12 months

• Change in mVSS score

  12 months

Study Arms (6)

Cohort 1: STP705 10 μg dose

EXPERIMENTAL

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

Drug: STP705

Cohort 2: STP705 20 μg dose

EXPERIMENTAL

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

Drug: STP705

Cohort 3: STP705 30 μg dose

EXPERIMENTAL

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

Drug: STP705

Cohort 4: STP705 40 μg dose

EXPERIMENTAL

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

Drug: STP705

Cohort 5: Placebo control

PLACEBO COMPARATOR

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

Other: Placebo

Cohort 6: SOC alone

NO INTERVENTION

SOC (no injection)

Interventions

STP705 DRUG

STP705 is composed of two siRNA oligonucleotides, targeting TGF-β1 and COX-2 mRNA, respectively

Also known as: STP705 Powder for Injection

Cohort 1: STP705 10 μg dose; Cohort 2: STP705 20 μg dose; Cohort 3: STP705 30 μg dose; Cohort 4: STP705 40 μg dose

Placebo OTHER

Saline

Cohort 5: Placebo control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sirnaomics: lead

Study Sites (3)

Investigate MD

Scottsdale, Arizona, 85255, United States

Location

Center for Clinical and Cosmetic Research

Aventura, Florida, 33180, United States

Location

Schweiger Dermatology

Hackensack, New Jersey, 07601, United States

Location

MeSH Terms

Conditions

Keloid

Interventions

Injections

Condition Hierarchy (Ancestors)

Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Mark Nestor, MD

  Center for Clinical and Cosmetic Research

  PRINCIPAL INVESTIGATOR

• David Goldberg, MD

  Schweiger Dermatology Group

  PRINCIPAL INVESTIGATOR

• Brenda LaTowsky, MD

  Investigate MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 14, 2021
• Study Start: April 29, 2021
• Primary Completion: May 17, 2023
• Study Completion: May 17, 2023
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)