KeloidPhase 2NCT04844840

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

A Phase 2 study testing STP705 in people with Keloid, run by Sirnaomics at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Keloid
What is being tested?: STP705
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 29 participants
Where: 3 sitesUnited States
Study dates: 29 Apr 2021to 17 May 2023
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 13Show fewer

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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Center for Clinical and Cosmetic Research
Aventura, Florida, 33180
Schweiger Dermatology
Hackensack, New Jersey, 07601
Investigate MD
Scottsdale, Arizona, 85255

Other trials in United States

About this study

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

Phase 2, randomized, double-blind, multiple arm, controlled study to evaluate safety \& efficacy of various doses of STP705 in reducing post Keloidectomy keloid recurrence.

Read the 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).

Conditions: Keloid
Being tested: STP705, Placebo
Medical subject headings: Keloid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

STP705Drug
Also called STP705 Powder for Injection
STP705 is composed of two siRNA oligonucleotides, targeting TGF-β1 and COX-2 mRNA, respectively
PlaceboOther
Saline

Study groups in NCT04844840
Study group	Role	What they receive
Cohort 1: STP705 10 μg dose	Experimental	STP705 at the assigned dose will be injected intradermal into the excised keloid site Receives: Drug: STP705
Cohort 2: STP705 20 μg dose	Experimental	STP705 at the assigned dose will be injected intradermal into the excised keloid site Receives: Drug: STP705
Cohort 3: STP705 30 μg dose	Experimental	STP705 at the assigned dose will be injected intradermal into the excised keloid site Receives: Drug: STP705
Cohort 4: STP705 40 μg dose	Experimental	STP705 at the assigned dose will be injected intradermal into the excised keloid site Receives: Drug: STP705
Cohort 5: Placebo control	Placebo comparator	Placebo (saline) will be injected intradermal into the excised keloid site Receives: Other: Placebo
Cohort 6: SOC alone	No intervention	SOC (no injection)

What is being measured

The primary outcome is the main question the study is designed to answer.

Rate of Recurrence
Rate of recurrence in subjects undergone surgery alone (with or without placebo) vs surgery and STP705
Measured: 12 months

Secondary outcomes (5)

Change of Keloid volume/size
Change in size of post excision keloid from baseline by volumetric measurements using quantitative imaging
Measured: 12 months
Change of Keloid size
Change of Keloid scar appearance from baseline evaluated by caliper
Measured: 12 months
Change of Keloid scar appearance
Change of Keloid scar appearance from baseline evaluated by POSAS
Measured: 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).
Measured: 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.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Apr 202117 May 2023

First posted14 Apr 2021
Study start29 Apr 2021
Primary completion17 May 2023
Study completion17 May 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for KeloidStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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: Double blind
Who is masked: Participant, Investigator
Enrolment: 29 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04844840
Sponsor's protocol ID: SRN-705-007
Status last verified: Mar 2024
First submitted: 8 Apr 2021
Last updated: 19 Mar 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Keloid trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04844840
Acronym / sponsor ID: SRN-705-007
Conditions: Keloid
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 29 participants (actual)
Lead sponsor: SirnaomicsIndustry (pharma, biotech, devices)
Study start: 29 Apr 2021 (actual)
Primary completion: 17 May 2023 (actual)
Study completion: 17 May 2023 (actual)
First posted: 14 Apr 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 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).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 6
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.

Arm	Type	Receives
Cohort 1: STP705 10 μg dose	Experimental	Drug: STP705STP705 at the assigned dose will be injected intradermal into the excised keloid site
Cohort 2: STP705 20 μg dose	Experimental	Drug: STP705STP705 at the assigned dose will be injected intradermal into the excised keloid site
Cohort 3: STP705 30 μg dose	Experimental	Drug: STP705STP705 at the assigned dose will be injected intradermal into the excised keloid site
Cohort 4: STP705 40 μg dose	Experimental	Drug: STP705STP705 at the assigned dose will be injected intradermal into the excised keloid site
Cohort 5: Placebo control	Placebo comparator	Other: PlaceboPlacebo (saline) will be injected intradermal into the excised keloid site
Cohort 6: SOC alone	No intervention	–SOC (no injection)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (13 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
STP705Also: STP705 Powder for InjectionSTP705 is composed of two siRNA oligonucleotides, targeting TGF-β1 and COX-2 mRNA, respectively	Drug	Cohort 1: STP705 10 μg dose, Cohort 2: STP705 20 μg dose, Cohort 3: STP705 30 μg dose, Cohort 4: STP705 40 μg dose
PlaceboSaline	Other	Cohort 5: Placebo control

Primary outcome

Rate of Recurrence
Time frame: 12 months
Rate of recurrence in subjects undergone surgery alone (with or without placebo) vs surgery and STP705

5 secondary outcomes

Change of Keloid volume/size
Time frame: 12 months
Change of Keloid size
Time frame: 12 months
Change of Keloid scar appearance
Time frame: 12 months
Change in DLQI score
Time frame: 12 months
Change in mVSS score
Time frame: 12 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
Individual participant dataSharing planned: No

Related trials for Keloid

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Fractional Radiofrequency With Streroids Versus Fractional CO2 Laser With Steroids in the Treatment of Keloids
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Ritlecitinib in Patients With Keloids or Those Undergoing Keloidectomy
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mark Nestor, MD principal investigator

Center for Clinical and Cosmetic Research

David Goldberg, MD principal investigator

Schweiger Dermatology Group

Brenda LaTowsky, MD principal investigator

Investigate MD

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing STP705 in people with Keloid, run by Sirnaomics at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Recurrence (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04844840.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2024.