Study to Evaluate Fractional Collagen Synthesis Within Keloid Scars and Identify Biomarkers of Keloid Scars

May 12, 2017 updated by: GlaxoSmithKline

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
9

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, E1 2AT
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Triamcinolone acetonide
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
Drug: Triamcinolone acetonide
Triamcinolone acetonide will be administered as intra-lesional injection in the keloid(s).
PLACEBO_COMPARATOR: Placebo
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.
Drug: Placebo
Placebo will supplied as commercial injectable saline, and will be administered as intra-lesional injection in the keloid(s).
NO_INTERVENTION: No treatment
Keloid(s) assigned 'No Treatment' will not receive any treatment.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Week 6-8

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Keloid scar volume before first dose and immediately prior to surgery
Time Frame: Day 1 and Week 6-8
For each keloid under evaluation, the keloid volume will be measured using three-dimensional (3D) photography
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
For each keloid under evaluation, the keloid surface area will be measured using 3D photography
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
For each keloid under evaluation, the keloid length and height will be measured using 3D photography
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
For each keloid under evaluation, the keloid vascularity will be measured by laser Doppler
Day 1 and Week 6-8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 5, 2015

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 5, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 31, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 7, 2013

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 15, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 117287

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