FibrosisPhase 1NCT01978301
Study to Evaluate Fractional Collagen Synthesis Within Keloid Scars and Identify Biomarkers of Keloid Scars
A Phase 1 study testing Triamcinolone acetonide in people with Fibrosis, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
This is a 3-arm randomised clinical enabling study, with no investigational product. Keloid patients who are scheduled for surgical excision of one or more keloid scars (up to nine) will be recruited to the study. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Fibrosis
- What is being tested?
- Triamcinolone acetonide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Apr 2014to 5 Feb 2015
- Phase
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects have at least one keloid scar scheduled for removal as part of their normal course of treatment
- Males or females aged between 18 and 55 years of age inclusive, at the time of signing the informed consent.
- A female subject is eligible to participate if she is of: Child-bearing potential with negative pregnancy test as determined by urine human chorionic gonadotropin (hCG) test at screening, AND; agrees not to become pregnant during the course of the study and for at least 1 month after completion of heavy water consumption; OR is of non child-bearing potential
- Male subjects must agree not to father a child during the study and for at least 1 month after completion of heavy water consumption.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
Who cannot join
- Keloids to be randomised must not have received steroid treatment for at least two months prior to screening.
- Evidence of other skin conditions or scarring in the region of keloid scaring (including but not limited to: hypertrophic scars, eczema, psoriasis, etc.) unless the Investigator, in consultation with the GSK medical monitor, agree that the condition is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- History of regular alcohol consumption that could preclude safe completion of the study.
- History of sensitivity to corticosteroids or history of drug or other allergy that, in the opinion of the investigator or GlaxoSmithKline (GSK) Medical Monitor, contraindicates their participation.
- Subjects currently receiving oral corticosteroids.
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- Subjects with a recent history of tuberculosis (TB) (within last three years).
- Evidence or recent history (past two weeks) of any infection (viral, bacterial, fungal, protozoan, or helminthic).
- History of recurrent fungal infection.
- Lactating females.
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Open Label Placebo Controlled Study to Evaluate Fractional Collagen Synthesis in Keloids and Identify Biomarkers of Keloid Biology for Potential Application in Future Clinical Trials
This is a 3-arm randomised clinical enabling study, with no investigational product. Keloid patients who are scheduled for surgical excision of one or more keloid scars (up to nine) will be recruited to the study. The aim is to investigate how collagen synthesis within keloid scars is affected by the current approved steroid treatment for keloids, triamcinolone acetonide (TAC). The primary endpoint will be fractional collagen synthesis in keloids which have received intra-lesional injections of TAC, placebo or no treatment prior to their removal. Fractional collagen synthesis will be determined using an established isotope/mass spectrometric technique which measures levels of deuterium incorporation into collagen following administration of heavy water to the subject. In addition; keloid tissue samples will be evaluated post surgery to identify further biomarkers of extracellular matrix synthesis and degradation for application in future clinical studies. Subjects will complete a screening visit and will then be randomised to receive three intra-lesional injections of TAC or placebo, or no treatment, at an interval of 2-3 weeks. Subjects will be randomised to different treatment sequences depending on the number of keloids they have scheduled for surgery, in such a way that subjects with multiple keloids will receive different arms of study treatment in their different keloids. Planned surgery for removal of their keloid(s) will be performed at week 6-8. All subjects will receive daily heavy water (Deuterium oxide) administration (twice daily or thrice daily as directed), with the first dose being taken at the Week 2 clinic visit and the final dose being taken on the day prior to surgery. A follow-up visit will be conducted at 1-4 weeks post-surgery.
- Conditions
- Fibrosis
- Being tested
- Triamcinolone acetonide, Placebo
- Keywords
- triamcinolone acetonide (TAC), heavy water, fibrosis, deuterium, collagen degradation, collagen synthesis, Keloid, patient
- Medical subject headings
- Fibrosis, Keloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone acetonideDrug
Triamcinolone acetonide will be administered as intra-lesional injection in the keloid(s).
PlaceboDrug
Placebo will supplied as commercial injectable saline, and will be administered as intra-lesional injection in the keloid(s).
| Study group | Role | What they receive |
|---|---|---|
| Triamcinolone acetonide | Active comparator | Subjects will receive three intra-lesional injections of triamcinolone acetonide in their qualifying keloid(s), at 2-3 weeks intervals, according to their assigned treatment sequence Receives: Drug: Triamcinolone acetonide |
| Placebo | Placebo comparator | Subjects will receive three intra-lesional injections of placebo in their qualifying keloid(s), at 2-3 weeks intervals, according to their assigned treatment sequence. Receives: Drug: Placebo |
| No treatment | No intervention | Keloid(s) assigned 'No Treatment' will not receive any treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional synthesis of collagen in keloid scars
Post surgical excision of keloids, tissue samples will be obtained by snap frozen biopsies. Fractional synthesis of collagen (that is, the fraction of the collagen that is newly synthesised during the labelling period) will be determined using mass spectrometry which measures the levels of deuterium incorporation into hydroxyproline or alanine in the collagen from the excised tissue samples, following administration of heavy water (Deuterium oxide) to the subject
Measured: Week 6-8
Secondary outcomes (4)
Keloid scar volume before first dose and immediately prior to surgery
For each keloid under evaluation, the keloid volume will be measured using three-dimensional (3D) photography
Measured: Day 1 and Week 6-8
Keloid scar surface area before first dose and immediately prior to surgery
For each keloid under evaluation, the keloid surface area will be measured using 3D photography
Measured: Day 1 and Week 6-8
Keloid scar length and height before first dose and immediately prior to surgery
For each keloid under evaluation, the keloid length and height will be measured using 3D photography
Measured: Day 1 and Week 6-8
Keloid scar vascularity before first dose and immediately prior to surgery
For each keloid under evaluation, the keloid vascularity will be measured by laser Doppler
Measured: Day 1 and Week 6-8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2013 (estimated)
- Study start15 Apr 2014
- Primary completion5 Feb 2015
- Study completion5 Feb 2015
Why it stopped: Temporary hold on recruitment during staff changes at the site
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibrosisStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01978301
- Sponsor's protocol ID
- 117287
- Status last verified
- May 2017
- First submitted
- 31 Oct 2013
- Last updated
- 15 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Open Label Placebo Controlled Study to Evaluate Fractional Collagen Synthesis in Keloids and Identify Biomarkers of Keloid Biology for Potential Application in Future Clinical Trials
- ClinicalTrials.gov ID
- NCT01978301
- Acronym / sponsor ID
- 117287
- Conditions
- Fibrosis
- Keywords
- triamcinolone acetonide (TAC), heavy water, fibrosis, deuterium, collagen degradation, collagen synthesis, Keloid, patient
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Temporary hold on recruitment during staff changes at the site
- Enrolment
- 9 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 15 Apr 2014 (actual)
- Primary completion
- 5 Feb 2015 (actual)
- Study completion
- 5 Feb 2015 (actual)
- First posted
- 7 Nov 2013 (estimated)
- 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.
This is a 3-arm randomised clinical enabling study, with no investigational product. Keloid patients who are scheduled for surgical excision of one or more keloid scars (up to nine) will be recruited to the study. The aim is to investigate how collagen synthesis within keloid scars is affected by the current approved steroid treatment for keloids, triamcinolone acetonide (TAC). The primary endpoint will be fractional collagen synthesis in keloids which have received intra-lesional injections of TAC, placebo or no treatment prior to their removal. Fractional collagen synthesis will be determined using an established isotope/mass spectrometric technique which measures levels of deuterium incorporation into collagen following administration of heavy water to the subject. In addition; keloid tissue samples will be evaluated post surgery to identify further biomarkers of extracellular matrix synthesis and degradation for application in future clinical studies. Subjects will complete a screening visit and will then be randomised to receive three intra-lesional injections of TAC or placebo, or no treatment, at an interval of 2-3 weeks. Subjects will be randomised to different treatment sequences depending on the number of keloids they have scheduled for surgery, in such a way that subjects with multiple keloids will receive different arms of study treatment in their different keloids. Planned surgery for removal of their keloid(s) will be performed at week 6-8. All subjects will receive daily heavy water (Deuterium oxide) administration (twice daily or thrice daily as directed), with the first dose being taken at the Week 2 clinic visit and the final dose being taken on the day prior to surgery. A follow-up visit will be conducted at 1-4 weeks post-surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Triamcinolone acetonide | Active comparator | Drug: Triamcinolone acetonideSubjects will receive three intra-lesional injections of triamcinolone acetonide in their qualifying keloid(s), at 2-3 weeks intervals, according to their assigned treatment sequence |
| Placebo | Placebo comparator | Drug: PlaceboSubjects will receive three intra-lesional injections of placebo in their qualifying keloid(s), at 2-3 weeks intervals, according to their assigned treatment sequence. |
| No treatment | No intervention | –Keloid(s) assigned 'No Treatment' will not receive any treatment. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subjects have at least one keloid scar scheduled for removal as part of their normal course of treatment
- Males or females aged between 18 and 55 years of age inclusive, at the time of signing the informed consent.
- A female subject is eligible to participate if she is of: Child-bearing potential with negative pregnancy test as determined by urine human chorionic gonadotropin (hCG) test at screening, AND; agrees not to become pregnant during the course of the study and for at least 1 month after completion of heavy water consumption; OR is of non child-bearing potential
- Male subjects must agree not to father a child during the study and for at least 1 month after completion of heavy water consumption.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
Key exclusion criteria (11 listed)
- Keloids to be randomised must not have received steroid treatment for at least two months prior to screening.
- Evidence of other skin conditions or scarring in the region of keloid scaring (including but not limited to: hypertrophic scars, eczema, psoriasis, etc.) unless the Investigator, in consultation with the GSK medical monitor, agree that the condition is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- History of regular alcohol consumption that could preclude safe completion of the study.
- History of sensitivity to corticosteroids or history of drug or other allergy that, in the opinion of the investigator or GlaxoSmithKline (GSK) Medical Monitor, contraindicates their participation.
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 |
|---|---|---|
| Triamcinolone acetonideTriamcinolone acetonide will be administered as intra-lesional injection in the keloid(s). | Drug | Triamcinolone acetonide |
| PlaceboPlacebo will supplied as commercial injectable saline, and will be administered as intra-lesional injection in the keloid(s). | Drug | Placebo |
Primary outcome
Fractional synthesis of collagen in keloid scars
Time frame: Week 6-8
Post surgical excision of keloids, tissue samples will be obtained by snap frozen biopsies. Fractional synthesis of collagen (that is, the fraction of the collagen that is newly synthesised during the labelling period) will be determined using mass spectrometry which measures the levels of deuterium incorporation into hydroxyproline or alanine in the collagen from the excised tissue samples, following administration of heavy water (Deuterium oxide) to the subject
4 secondary outcomes
Keloid scar volume before first dose and immediately prior to surgery
Time frame: Day 1 and Week 6-8
Keloid scar surface area before first dose and immediately prior to surgery
Time frame: Day 1 and Week 6-8
Keloid scar length and height before first dose and immediately prior to surgery
Time frame: Day 1 and Week 6-8
Keloid scar vascularity before first dose and immediately prior to surgery
Time frame: Day 1 and Week 6-8
Results and safety
The study was stopped early (reason given: Temporary hold on recruitment during staff changes at the site). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
- Results for study 117287 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Triamcinolone acetonide in people with Fibrosis, run by GlaxoSmithKline at 1 site in United Kingdom.
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 11 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: stopped early, as of the sponsor's last update on 15 May 2017. 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 Kingdom. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early (reason given: Temporary hold on recruitment during staff changes at the site). Results are not available in the source record.
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?
Fractional synthesis of collagen in keloid scars (time frame: Week 6-8). 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 15 May 2017.