KeloidEarly Phase 1NCT04049552
RAPA-Keloid Study of Keloid Regression
A Early Phase 1 study testing Rapamycin 8% Ointment in people with Keloid, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
1. To test whether topical rapamycin regresses established keloids in humans by measuring surface area and height changes in the scar over time (6 months) 2. To test safety of product and feasibility of conduct for future clinical trial Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Keloid
- What is being tested?
- Rapamycin 8% Ointment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2020to 2 May 2021
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject must have at least 2 keloid scars (for at least 1 year) in similar body locations that are easy to reach to apply ointment to
- Subject will be in good health with all chronic diseases (such as hypertension, coronary artery disease, etc.) clinically stable
- Cognitive functioning sufficient to provide informed consent
- Physically able to apply ointment to keloids daily
- Able to attend monthly clinic visits for 6 months
Who cannot join
- Diagnosis of diabetes
- Subjects taking the following medications: systemic steroid or immunosuppressant therapy within the past 6 months
- Local area steroidal treatment within the past 3 months
- History of allergy to rapamycin of petrolatum-based products
Trial locations and contacts
1 site in 1 country.
United States1 site
Audie L Murphy Memorial Veterans Hospital
San Antonio, Texas, 78229
About this study
Official title: Effect of Topical Rapamycin Ointment on Keloid Regression: A Pilot Study in Human Subjects (RAPA-Keloid)
- To test whether topical rapamycin regresses established keloids in humans by measuring surface area and height changes in the scar over time (6 months)
- To test safety of product and feasibility of conduct for future clinical trial
Read the detailed description
This pilot trial will use daily 0.5-1.0 ml applications of 8% RAPA (Rapamycin) in a petrolatum vehicle to treat established keloid lesions in 5 persons with at least 2 chronic keloids in similar body regions (greater than 1-year duration). Treatment will be applied once daily for 6 months. One keloid will receive 8% RAPA ointment and the other keloid will receive petrolatum-only ointment as a control. Surface areas and height of keloids will be monitored pre- and post-treatment to evaluate responses.
Keloid surface area and height changes will be measured pre-treatment and thereafter on a monthly basis using standardized digital photography with a tripod-mounted 8MP Canon S5is camera and calipers to measure keloid height (37).
Surface areas of all photographed lesions will be measured with Image J (http://rsbweb.nih.gov/ij/index.html), a public image-processing program that was used to analyze preliminary data and this study will use the same approach.
- Conditions
- Keloid
- Being tested
- Rapamycin 8% Ointment, Placebo
- Medical subject headings
- Keloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapamycin 8% OintmentDrug
Also called Rapamycin ointment
A compounded ointment containing 8% rapamycin
PlaceboDrug
Also called Petrolatum ointment
Petrolatum ointment placebo
| Study group | Role | What they receive |
|---|---|---|
| RAPA intervention | Experimental | Rapamycin ointment will be applied to one keloid on the subject Receives: Drug: Rapamycin 8% Ointment |
| Placebo | Placebo comparator | Placebo will be applied as a control on one keloid on the subject Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Keloid Surface Area
Measurement of surface area of keloid
Measured: Baseline to 6 months
Secondary outcomes (1)
Change in Keloid Height
Measurement of height of keloid
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start24 Jan 2020
- Primary completion24 Aug 2020
- Study completion2 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Study participants will serve as their own control, using intervention on one keloid and placebo on the other
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dean L Kellogg Jr, MD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04049552
- Sponsor's protocol ID
- HSC20190291H
- Status last verified
- Sep 2021
- First submitted
- 6 Aug 2019
- Last updated
- 29 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Topical Rapamycin Ointment on Keloid Regression: A Pilot Study in Human Subjects (RAPA-Keloid)
- ClinicalTrials.gov ID
- NCT04049552
- Acronym / sponsor ID
- HSC20190291H
- Conditions
- Keloid
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- 24 Jan 2020 (actual)
- Primary completion
- 24 Aug 2020 (actual)
- Study completion
- 2 May 2021 (actual)
- First posted
- 8 Aug 2019 (actual)
- Results
- Posted 28 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To test whether topical rapamycin regresses established keloids in humans by measuring surface area and height changes in the scar over time (6 months)
- To test safety of product and feasibility of conduct for future clinical trial
Detailed description
This pilot trial will use daily 0.5-1.0 ml applications of 8% RAPA (Rapamycin) in a petrolatum vehicle to treat established keloid lesions in 5 persons with at least 2 chronic keloids in similar body regions (greater than 1-year duration). Treatment will be applied once daily for 6 months. One keloid will receive 8% RAPA ointment and the other keloid will receive petrolatum-only ointment as a control. Surface areas and height of keloids will be monitored pre- and post-treatment to evaluate responses.
Keloid surface area and height changes will be measured pre-treatment and thereafter on a monthly basis using standardized digital photography with a tripod-mounted 8MP Canon S5is camera and calipers to measure keloid height (37).
Surface areas of all photographed lesions will be measured with Image J (http://rsbweb.nih.gov/ij/index.html), a public image-processing program that was used to analyze preliminary data and this study will use the same approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Study participants will serve as their own control, using intervention on one keloid and placebo on the other
| Arm | Type | Receives |
|---|---|---|
| RAPA intervention | Experimental | Drug: Rapamycin 8% OintmentRapamycin ointment will be applied to one keloid on the subject |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo will be applied as a control on one keloid on the subject |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject must have at least 2 keloid scars (for at least 1 year) in similar body locations that are easy to reach to apply ointment to
- Subject will be in good health with all chronic diseases (such as hypertension, coronary artery disease, etc.) clinically stable
- Cognitive functioning sufficient to provide informed consent
- Physically able to apply ointment to keloids daily
- Able to attend monthly clinic visits for 6 months
Key exclusion criteria (4 listed)
- Diagnosis of diabetes
- Subjects taking the following medications: systemic steroid or immunosuppressant therapy within the past 6 months
- Local area steroidal treatment within the past 3 months
- History of allergy to rapamycin of petrolatum-based products
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 |
|---|---|---|
| Rapamycin 8% OintmentAlso: Rapamycin ointmentA compounded ointment containing 8% rapamycin | Drug | RAPA intervention |
| PlaceboAlso: Petrolatum ointmentPetrolatum ointment placebo | Drug | Placebo |
Primary outcome
Change in Keloid Surface Area
Time frame: Baseline to 6 months
Measurement of surface area of keloid
1 secondary outcome
Change in Keloid Height
Time frame: Baseline to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Dean L Kellogg Jr, MD principal investigator
The University of Texas Health Science Center at San Antonio
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 Rapamycin 8% Ointment in people with Keloid, run by The University of Texas Health Science Center at San Antonio 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 5 inclusion and 4 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 29 Sep 2021. 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?
Yes. Results are posted in the registry (first posted 28 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Surface Area (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2021.