Clinical trial NCT04844840: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Keloid
Lead sponsor: Sirnaomics
Sponsor class: INDUSTRY
First posted: 2021-04-14
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of Recurrence
timeFrame: 12 months
Secondary outcomes:
measure: Change of Keloid volume/size
timeFrame: 12 months
measure: Change of Keloid size
timeFrame: 12 months
measure: Change of Keloid scar appearance
timeFrame: 12 months
measure: Change in DLQI score
timeFrame: 12 months
measure: Change in mVSS score
timeFrame: 12 months
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Investigate MD
state: Arizona
city: Aventura
country: United States
facility: Center for Clinical and Cosmetic Research
state: Florida
city: Hackensack
country: United States
facility: Schweiger Dermatology
state: New Jersey
Study officials:
affiliation: Center for Clinical and Cosmetic Research
name: Mark Nestor, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Schweiger Dermatology Group
name: David Goldberg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Investigate MD
name: Brenda LaTowsky, MD
role: PRINCIPAL_INVESTIGATOR
References: