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

  • STATUS
    Recruiting
  • End date
    May 16, 2022
  • participants needed
    50
  • sponsor
    Sirnaomics
Updated on 16 May 2021

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.

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 50 adult subjects will be treated once weekly for 4 weeks. One eligible qualifying keloid will be excised. The subjects will be randomized to receive STP705 or placebo 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 0.30cm, and be suitable for surgical excision which will result in a single wound no greater than 8 cm long.

Assigned dose of STP705 or placebo will be injected along the keloid excision site, once weekly for 4 weeks beginning the day of keloid excision.

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).

Details
Condition Keloid, Collagen disease, Scar, Collagen Vascular Diseases, Scar Tissue
Treatment Placebo, STP705
Clinical Study IdentifierNCT04844840
SponsorSirnaomics
Last Modified on16 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Healthy males or females, 18 to 60 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 0.30cm, and be suitable for surgical excision which will result in a single wound no greater than 8 cm 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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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