A Phase 2 interventional study of STP705 and Placebo in Keloid, sponsored by Sirnaomics. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-19.
Sponsored by Sirnaomics · Phase 2, Interventional, and Treatment
Phase 2, randomized, double-blind, multiple arm, controlled study to evaluate safety \& efficacy of various doses of STP705 in reducing post Keloidectomy keloid recurrence.
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).
138 studies on the registry are indexed under Keloid; 26 are open to participants now.
This study's enrollment of 29 is close to the median of 30 across 109 interventional studies indexed under Keloid.
Browse Keloid studies →Sirnaomics is the lead sponsor of 13 studies on the registry; 1 is open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 2 (22%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
STP705 at the assigned dose will be injected intradermal into the excised keloid site
Drug: STP705
STP705 at the assigned dose will be injected intradermal into the excised keloid site
Drug: STP705
STP705 at the assigned dose will be injected intradermal into the excised keloid site
Drug: STP705
STP705 at the assigned dose will be injected intradermal into the excised keloid site
Drug: STP705
Placebo (saline) will be injected intradermal into the excised keloid site
Other: Placebo
SOC (no injection)
STP705 is composed of two siRNA oligonucleotides, targeting TGF-β1 and COX-2 mRNA, respectively
Also known as: STP705 Powder for Injection
Saline
Rate of Recurrence
Rate of recurrence in subjects undergone surgery alone (with or without placebo) vs surgery and STP705
Time frame: 12 months
Change of Keloid volume/size
Change in size of post excision keloid from baseline by volumetric measurements using quantitative imaging
Time frame: 12 months
Change of Keloid size
Change of Keloid scar appearance from baseline evaluated by caliper
Time frame: 12 months
Change of Keloid scar appearance
Change of Keloid scar appearance from baseline evaluated by POSAS
Time frame: 12 months
Change in DLQI score
The Dermatology Life Quality Index (DLQI) is a self-reported 10-item questionnaire assessing the impact of skin disease on the patient over the previous week. The items cover symptoms, treatment, activity limitations, and emotional reactions to having a skin disease. Nine items have four response options: "Not at all", "A little", "A lot", and "Very much", whereas item 7 first asks whether work or study has been prevented and then (if "No") to what degree the skin condition has been a problem at work/study ("A lot", "A little", or "Not at all"). Eight of the items also have a "Not relevant" option that is scored "0", indicating no problem. Individual item scores are summed to derive a total DLQI score that can range from 0 to 30, with higher scores indicating worse health- related quality of life (HRQL).
Time frame: 12 months
Change in mVSS score
The modified Vancouver Scar Scale (mVSS) performs a comprehensive measurement rating characteristic of pigmentation, vascularity, pliability, and height. For each subject, a total Vancouver score was determined by summing the scores of the four individual parameters to generate a score ranging from 0 to 15 points, with higher scores indicating worse score severity.
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Apr 2021 to primary completion in May 2023, 24 months.
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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cotsiranib
Sirnaomics