KeloidEarly Phase 1NCT05330078
Examining the Therapeutic Potential of Botulinum Toxin Type A in the Treatment of Keloids
A Early Phase 1 study testing Botulinum toxin type A in people with Keloid, run by University of California, San Diego at 1 site in United States.
Trial summary
Keloids are a common form of hypertrophic scars that by definition last beyond 6 months and grow beyond the site of initial injury. Keloids are a common complaint from patients in dermatology and cause significant functional impairment due to cosmetic disfigurement, itching and pain. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Keloid
- What is being tested?
- Botulinum toxin type A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2022to 31 May 2023
- Phase
- Early Phase 1
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 80
- History of keloid scar for at least 12 months
- Absence of keloid treatment for past 12 months
- Participant must have a keloid scar of at least 4cm in length.
- Participants who score at least 8 or higher on the Vancouver Scar Scale
- Subjects who score 5 (neither satisfied nor dissatisfied) to 10 (maximally dissatisfied) on the patient subjective score of dissatisfaction with keloid.
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- Participants must be in stable health, as confirmed by medical history, per investigator judgment
- Participants must be able to read, sign, and understand the informed consent
- Participants must be willing to avoid any other treatments to the keloid that will be treated including corticosteroid injections, surgical excision, chemotherapeutic injection, lasers, light-based therapy, radiation therapy, cryotherapy, or pressure therapy, during the study period.
Who cannot join
- Pregnant women
- Keloids on face, neck or scalp
- History of hypersensitivity to botulinum toxin
- Ongoing or planned treatment with chemotherapy, radiation, isotretinoin, cytokine-based immunotherapies
- Any planned surgery during study period
- Known diagnosis of insulin dependent diabetes mellitus
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- Patients being treating with dupilumab for any indication
- Patients taking aminoglycoside antibiotics
- Patients with pre-existing neuromuscular disorders
- Patients with infection around potential injection sites
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Diego
San Diego, California, 92122
About this study
Keloids are a common form of hypertrophic scars that by definition last beyond 6 months and grow beyond the site of initial injury. Keloids are a common complaint from patients in dermatology and cause significant functional impairment due to cosmetic disfigurement, itching and pain. Current treatment modalities include intralesional corticosteroids, chemotherapeutic agents and laser therapy. Initial reports have demonstrated that Botulinum toxin type A may be a viable treatment option for keloids that can reduce keloid size and reduce associated symptoms while having fewer side effects when compared to intralesional corticosteroid injection, which can cause unnatural blood vessel growth or skin thinning. To date, no study has carefully examined the efficacy of Botulinum toxin type A in treating keloids or its mechanistic effects on keloid biology. Our aim in this study is to pursue a rigorous, randomized control trial to assess the potential use Botulinum toxin type A to treat keloids. Efficacy will be objectively be mentioned by change in keloid size after treatment, along with subjective measures of patient satisfaction and symptoms, and finally physician rated scores. Also, samples from three patients will be analyzed in the laboratory setting to determine the underlying molecular mechanism behind the effects of Botulinum toxin type A on keloid biology.
- Conditions
- Keloid
- Being tested
- Botulinum toxin type A, Vehicle
- Medical subject headings
- Keloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participants will receive Botulinum toxin type A 5 units / cm3 with injections of 0.2mL spaced evenly 1cm apart within the treatment area (half of the keloid). Each treatment will consist of a maximum of 2 mL (10 injection sites, 50 unit total) of the study drug. Patients will undergo 3 treatments, 6 weeks apart.
VehicleDrug
Also called vehicle control (saline)
Participants will receive saline injections of 0.2mL spaced evenly 1cm apart within the placebo area (half of the keloid). Each treatment will consist of a maximum of 2 mL (10 injection sites) of the vehicle control (saline). Patients will undergo 3 treatments, 6 weeks apart.
| Study group | Role | What they receive |
|---|---|---|
| Keloid treatment with botulinum toxin type A | Experimental | Participants will receive Botulinum toxin type A 5 units / cm3 with injections of 0.2mL spaced evenly 1cm apart within the treatment area (half of the keloid). Each treatment will consist of a maximum of 2 mL (10 injection sites, 50 unit total) of the study drug. Patients will undergo 3 treatments, 6 weeks apart. Receives: Drug: Botulinum toxin type A |
| Keloid treatment with vehicle control (saline) | Placebo comparator | Participants will receive saline injections of 0.2mL spaced evenly 1cm apart within the placebo area (half of the keloid). Each treatment will consist of a maximum of 2 mL (10 injection sites) of the vehicle control (saline). Patients will undergo 3 treatments, 6 weeks apart. Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Keloid volume
Keloid volume will be measured using the high resolution 3D imaging system (Cherry Imaging platform)
Measured: Measurements obtained at 0 and 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start11 Mar 2022
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for KeloidStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single center, randomized, single-masked, prospective experimental study. Half the keloid tissue will be treated with Botulinum toxin type A while the other half will be treated with a vehicle control (saline) of matching number of injections and volume. All treated keloids will serve as their own internal control. The treatment and control sides of the keloid will clearly be documented in the patient's chart and source documents to allow the study physician to track treatment vs vehicle control portions of the keloid.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arisa Ortiz, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05330078
- Sponsor's protocol ID
- 201088
- Status last verified
- Nov 2025
- First submitted
- 16 Mar 2022
- Last updated
- 6 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Publication will be submitted in a peer reviewed journal.
Publications
Bi M, Sun P, Li D, Dong Z, Chen Z. Intralesional Injection of Botulinum Toxin Type A Compared with Intralesional Injection of Corticosteroid for the Treatment of Hypertrophic Scar and Keloid: A Systematic Review and Meta-Analysis. Med Sci Monit. 2019 Apr 22;25:2950-2958. doi: 10.12659/MSM.916305.
PubMed 31006769Cocco A, Albanese A. Recent developments in clinical trials of botulinum neurotoxins. Toxicon. 2018 Jun 1;147:77-83. doi: 10.1016/j.toxicon.2017.08.014. Epub 2017 Aug 14.
PubMed 28818530Shaarawy E, Hegazy RA, Abdel Hay RM. Intralesional botulinum toxin type A equally effective and better tolerated than intralesional steroid in the treatment of keloids: a randomized controlled trial. J Cosmet Dermatol. 2015 Jun;14(2):161-6. doi: 10.1111/jocd.12134. Epub 2015 Mar 24.
PubMed 25810045
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Therapeutic Potential of Botulinum Toxin Type A in the Treatment of Keloids
- ClinicalTrials.gov ID
- NCT05330078
- Acronym / sponsor ID
- 201088
- Conditions
- Keloid
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 11 Mar 2022 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 15 Apr 2022 (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.
Keloids are a common form of hypertrophic scars that by definition last beyond 6 months and grow beyond the site of initial injury. Keloids are a common complaint from patients in dermatology and cause significant functional impairment due to cosmetic disfigurement, itching and pain. Current treatment modalities include intralesional corticosteroids, chemotherapeutic agents and laser therapy. Initial reports have demonstrated that Botulinum toxin type A may be a viable treatment option for keloids that can reduce keloid size and reduce associated symptoms while having fewer side effects when compared to intralesional corticosteroid injection, which can cause unnatural blood vessel growth or skin thinning. To date, no study has carefully examined the efficacy of Botulinum toxin type A in treating keloids or its mechanistic effects on keloid biology. Our aim in this study is to pursue a rigorous, randomized control trial to assess the potential use Botulinum toxin type A to treat keloids. Efficacy will be objectively be mentioned by change in keloid size after treatment, along with subjective measures of patient satisfaction and symptoms, and finally physician rated scores. Also, samples from three patients will be analyzed in the laboratory setting to determine the underlying molecular mechanism behind the effects of Botulinum toxin type A on keloid biology.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a single center, randomized, single-masked, prospective experimental study. Half the keloid tissue will be treated with Botulinum toxin type A while the other half will be treated with a vehicle control (saline) of matching number of injections and volume. All treated keloids will serve as their own internal control. The treatment and control sides of the keloid will clearly be documented in the patient's chart and source documents to allow the study physician to track treatment vs vehicle control portions of the keloid.
| Arm | Type | Receives |
|---|---|---|
| Keloid treatment with botulinum toxin type A | Experimental | Drug: Botulinum toxin type AParticipants will receive Botulinum toxin type A 5 units / cm3 with injections of 0.2mL spaced evenly 1cm apart within the treatment area (half of the keloid). Each treatment will consist of a maximum of 2 mL (10 injection sites, 50 unit total) of the study drug. Patients will undergo 3 treatments, 6 weeks apart. |
| Keloid treatment with vehicle control (saline) | Placebo comparator | Drug: VehicleParticipants will receive saline injections of 0.2mL spaced evenly 1cm apart within the placebo area (half of the keloid). Each treatment will consist of a maximum of 2 mL (10 injection sites) of the vehicle control (saline). Patients will undergo 3 treatments, 6 weeks apart. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adults aged 18 to 80
- History of keloid scar for at least 12 months
- Absence of keloid treatment for past 12 months
- Participant must have a keloid scar of at least 4cm in length.
- Participants who score at least 8 or higher on the Vancouver Scar Scale
Key exclusion criteria (10 listed)
- Pregnant women
- Keloids on face, neck or scalp
- History of hypersensitivity to botulinum toxin
- Ongoing or planned treatment with chemotherapy, radiation, isotretinoin, cytokine-based immunotherapies
- Any planned surgery during study period
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 |
|---|---|---|
| Botulinum toxin type AParticipants will receive Botulinum toxin type A 5 units / cm3 with injections of 0.2mL spaced evenly 1cm apart within the treatment area (half of the keloid). Each treatment will consist of a maximum of 2 mL (10 injection sites, 50 unit total) of the study drug. Patients will undergo 3 treatments, 6 weeks apart. | Drug | Keloid treatment with botulinum toxin type A |
| VehicleAlso: vehicle control (saline)Participants will receive saline injections of 0.2mL spaced evenly 1cm apart within the placebo area (half of the keloid). Each treatment will consist of a maximum of 2 mL (10 injection sites) of the vehicle control (saline). Patients will undergo 3 treatments, 6 weeks apart. | Drug | Keloid treatment with vehicle control (saline) |
Primary outcome
Change in Keloid volume
Time frame: Measurements obtained at 0 and 24 weeks.
Keloid volume will be measured using the high resolution 3D imaging system (Cherry Imaging platform)
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 6 Nov 2025.
- Background: PubMed 31006769Bi M, Sun P, Li D, Dong Z, Chen Z. Intralesional Injection of Botulinum Toxin Type A Compared with Intralesional Injection of Corticosteroid for the Treatment of Hypertrophic Scar and Keloid: A Systematic Review and Meta-Analysis. Med Sci Monit. 2019 Apr 22;25:2950-2958. doi: 10.12659/MSM.916305.
- Background: PubMed 28818530Cocco A, Albanese A. Recent developments in clinical trials of botulinum neurotoxins. Toxicon. 2018 Jun 1;147:77-83. doi: 10.1016/j.toxicon.2017.08.014. Epub 2017 Aug 14.
- Background: PubMed 25810045Shaarawy E, Hegazy RA, Abdel Hay RM. Intralesional botulinum toxin type A equally effective and better tolerated than intralesional steroid in the treatment of keloids: a randomized controlled trial. J Cosmet Dermatol. 2015 Jun;14(2):161-6. doi: 10.1111/jocd.12134. Epub 2015 Mar 24.
- Individual participant dataSharing planned: Undecided. Publication will be submitted in a peer reviewed journal.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Botulinum toxin type A in people with Keloid, run by University of California, San Diego at 1 site 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 9 inclusion and 10 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 6 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Change in Keloid volume (time frame: Measurements obtained at 0 and 24 weeks.). 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 NCT05330078, which also lists 3 linked publications.
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 6 Nov 2025.