Second-degree BurnPhase 2NCT03530150
Pirfenidone and Its Role in Burn Wound Healing
A Phase 2 study testing Pirfenidone Oral Product in people with Second-degree Burn, run by Universidad Autonoma de Nuevo Leon.
Trial summary
Burn patients which skin has been lost a rapid growth of the skin is a foremost in their treatment. Due to the injury, burn patients undergo a systemic inflammation that helps the skin heal faster. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Second-degree Burn
- What is being tested?
- Pirfenidone Oral Product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 22 Jun 2017
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with second-degree burns from any etiology with less than 24 hours of evolution.
Who cannot join
- Patients <18 years old
- Patients allergic to pirfenidone
- Pregnant patients
- Patients with renal or hepatic failure
- Patients who are not able to take the medication orally
- Conditions or drugs that alter wound healing (i.e. any kind of diabetes, lupus, having a history of using steroids, rheumatoid arthritis)
About this study
Official title: Pirfenidone and Its Efficacy in Wound Re-Epithelization in Patients With Second-Degree Burns: A Proof-of-Concept Randomized Controlled Trial
Burn patients which skin has been lost a rapid growth of the skin is a foremost in their treatment. Due to the injury, burn patients undergo a systemic inflammation that helps the skin heal faster. However, several studies have shown that this inflammation increases the levels of several inflammatory molecules that impairs skin growing, which further delays the recovery of burn patients. As such, by inhibiting these inflammatory molecules with the administration of a medication called pirfenidone burn patients might present faster rates of skin growth and recovery. Thus, patients suffering from a burn injury will be recruited at the emergency department of the Hospital University in Monterrey Mexico. Afterward, patients will be randomized to either receive pirfenidone 600 mg orally once per day or usual care consisting of covering the wound with hydrocolloid dressings. To assess the amount of newly growth skin investigators will take a small piece of the skin to further evaluate it through a microscope.
- Conditions
- Second-degree Burn
- Being tested
- Pirfenidone Oral Product
- Keywords
- Burns, Partial-thickness burn wounds, Re-epithelization, Second-Degree Wound, Pirfenidone, Wound Healing
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pirfenidone Oral ProductDrug
Also called Kitoscell
A pill containing 600 mg of pirfenidone
| Study group | Role | What they receive |
|---|---|---|
| Pirfenidone 600 mg | Active comparator | Burn patients randomly allocated to this group will receive pirfenidone 600 mg orally once per day for 21 days additionally to the coverage of the wound with non-adherent gauzes and bandages. The aforementioned coverings will be changed every 3 or 4 days until a complete re-epithelization is achieved. Receives: Drug: Pirfenidone Oral Product |
| Usual Care | No intervention | Burn patients randomly allocated to this group will only be treated by the usual care of our hospital which consists in covering the wound with non-adherent gauzes and bandages. These covering will be changed every 3 or 4 days until a complete re-epithelization is achieved. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epidermal re-epithelization
Thickness of the epidermal re-epithelization measured in micrometers using a digitial image software
Measured: Day 7
Secondary outcomes (4)
Presence of Fibrosis
A qualitative assessment of the presence of fibrotic tissue in the extracellular matrix using a light field microscope.
Measured: Day 0 and 7
Basal Membrane Integrity
A qualitative assessment of the presence and integrity of the basal membrane using a light field microscope.
Measured: Day 0 and 7
Presence of Collagen Fibers
A qualitative assessment of the presence of collagen fibers in the dermis using a light field microscope.
Measured: Day 0 and 7
Clinical Evaluations of Wound's Re-Epithelization
Clinical evaluation of wound's re-epithelization based on the judgement of an experienced plastic surgeon
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start1 Jan 2017
- Primary completion22 Jun 2017
- Study completion22 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Second-degree BurnStudies 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
- Burn patients will be divided to receive either 600 mg of pirfenidone or usual care
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Nuevo Leon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriel Angel Mecott-Rivera, Universidad Autonoma de Nuevo Leon
- Investigators
- Gabriel A Mecott-Rivera, MMS, Principal investigator, Universidad Autonoma de Nuevo Leon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03530150
- Sponsor's protocol ID
- CP14-004
- Status last verified
- May 2018
- First submitted
- 7 May 2018
- Last updated
- 21 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All information will be delivered by request. Possible individual participant data includes: Database Original Protocol Informed Consent
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pirfenidone and Its Efficacy in Wound Re-Epithelization in Patients With Second-Degree Burns: A Proof-of-Concept Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03530150
- Acronym / sponsor ID
- CP14-004
- Conditions
- Second-degree Burn
- Keywords
- Burns, Partial-thickness burn wounds, Re-epithelization, Second-Degree Wound, Pirfenidone, Wound Healing
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Universidad Autonoma de Nuevo LeonUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 22 Jun 2017 (actual)
- Study completion
- 22 Jun 2017 (actual)
- First posted
- 21 May 2018 (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.
Burn patients which skin has been lost a rapid growth of the skin is a foremost in their treatment. Due to the injury, burn patients undergo a systemic inflammation that helps the skin heal faster. However, several studies have shown that this inflammation increases the levels of several inflammatory molecules that impairs skin growing, which further delays the recovery of burn patients. As such, by inhibiting these inflammatory molecules with the administration of a medication called pirfenidone burn patients might present faster rates of skin growth and recovery. Thus, patients suffering from a burn injury will be recruited at the emergency department of the Hospital University in Monterrey Mexico. Afterward, patients will be randomized to either receive pirfenidone 600 mg orally once per day or usual care consisting of covering the wound with hydrocolloid dressings. To assess the amount of newly growth skin investigators will take a small piece of the skin to further evaluate it through a microscope.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Burn patients will be divided to receive either 600 mg of pirfenidone or usual care
| Arm | Type | Receives |
|---|---|---|
| Pirfenidone 600 mg | Active comparator | Drug: Pirfenidone Oral ProductBurn patients randomly allocated to this group will receive pirfenidone 600 mg orally once per day for 21 days additionally to the coverage of the wound with non-adherent gauzes and bandages. The aforementioned coverings will be changed every 3 or 4 days until a complete re-epithelization is achieved. |
| Usual Care | No intervention | –Burn patients randomly allocated to this group will only be treated by the usual care of our hospital which consists in covering the wound with non-adherent gauzes and bandages. These covering will be changed every 3 or 4 days until a complete re-epithelization is achieved. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with second-degree burns from any etiology with less than 24 hours of evolution.
Key exclusion criteria (6 listed)
- Patients <18 years old
- Patients allergic to pirfenidone
- Pregnant patients
- Patients with renal or hepatic failure
- Patients who are not able to take the medication orally
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 |
|---|---|---|
| Pirfenidone Oral ProductAlso: KitoscellA pill containing 600 mg of pirfenidone | Drug | Pirfenidone 600 mg |
Primary outcome
Epidermal re-epithelization
Time frame: Day 7
Thickness of the epidermal re-epithelization measured in micrometers using a digitial image software
4 secondary outcomes
Presence of Fibrosis
Time frame: Day 0 and 7
Basal Membrane Integrity
Time frame: Day 0 and 7
Presence of Collagen Fibers
Time frame: Day 0 and 7
Clinical Evaluations of Wound's Re-Epithelization
Time frame: Day 7
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 21 May 2018.
- Individual participant dataSharing planned: Yes. All information will be delivered by request. Possible individual participant data includes: Database Original Protocol Informed Consent
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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.
Gabriel A Mecott-Rivera, MMS principal investigator
Universidad Autonoma de Nuevo Leon
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pirfenidone Oral Product in people with Second-degree Burn, run by Universidad Autonoma de Nuevo Leon.
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 1 inclusion and 6 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 21 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Epidermal re-epithelization (time frame: Day 7). 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 21 May 2018.