KeloidPhase 3LADISLAONCT02823236
Efficacy of Intralesional Triamcinolone and 8% Topical Pirfenidone for Treatment of Keloid Scars
A Phase 3 study testing Topical Pirfenidone, Triamcinolone + Pirfenidone and Intralesional Triamcinolone in people with Keloid, run by Centro Dermatológico Dr. Ladislao de la Pascua at 1 site in Mexico.
Trial summary
The aim of the study is to assess the efficacy and safety of the combination of intralesional triamcinolone (at doses of 4mg / cm2 at intervals of 4 weeks) and topical pirfenidone 8% (every 8 hours continuously) compared with their isolated application, in the treatment of keloid scars in adults. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Keloid
- What is being tested?
- Topical Pirfenidone, Triamcinolone + Pirfenidone and Intralesional Triamcinolone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteMexico
- Study dates
- 24 Oct 2016to 1 May 2020
- Phase
- Phase 3
- 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 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Keloids size equal or major than 1 cm
- Keloids less than 5 years old
- Keloids in trunk
Who cannot join
- Keloid with a surgical indication
- Hypertrophic scars
- Scars after burn wounds
- Pregnancy
- Lactation
- Use of systemic chemotherapeutics or chronic use of systemic corticosteroids or immunosuppressive medication
Show all 14Show fewer
- Known hypersensitivity for triamcinolone or pirfenidone
- Severe comorbidity not controlled
- Inflammatory acne
- Diabetes Mellitus
- Hypertension
- Renal, hepatic or respiratory failure
- Topical treatment 4 weeks before recruitment
- Previous treatment with intralesional steroids
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Centro Dermatológico "Dr. Ladislao de la Pascua"
Mexico City, 06780
Martha Alejandra Morales-Sánchez, MD, MSc., 55387033 ext. 312, mmoraless@sersalud.df.gob.mx
About this study
Official title: Efficacy of Intralesional Triamcinolone and 8% Topical Pirfenidone for Treatment of Keloid Scars: 3-arm Trial
The aim of the study is to assess the efficacy and safety of the combination of intralesional triamcinolone (at doses of 4mg / cm2 at intervals of 4 weeks) and topical pirfenidone 8% (every 8 hours continuously) compared with their isolated application, in the treatment of keloid scars in adults. The duration of this three-arm clinical trial will be 12 months, a 6-month period for treatment and a follow-up of 6 months to assess recurrences. The estimated number of persons to be recruited and randomized for the study is 102.
Read the detailed description
Individuals with keloid scars will be randomized to 3 arms of treatment in order to assess the efficacy of combining intralesional triamcinolone and topical pirfenidone compared with the isolated application of these drugs. The interventions will last 6 months but the individuals will be assessed monthly to determine recurrences for 6 more months. The scar size will be measure at weeks 12, 24 and 52.
- Conditions
- Keloid
- Being tested
- Topical Pirfenidone, Triamcinolone + Pirfenidone, Intralesional Triamcinolone
- Keywords
- Keloid, Scar
- Medical subject headings
- Keloid, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical PirfenidoneDrug
Also called KitosCell
Pirfenidone 8% gel will be applied three times per day during 6 months in the surface of the keloid scar.
Triamcinolone + PirfenidoneDrug
Also called Kenalog + KitosCell
Triamcinolone will be injected in the keloid scar 4 mg/cm2 every 4 weeks for 6 months. And pirfenidone 8% gel will be applied three times per day during 6 months in the surface of the keloid scar.
Intralesional TriamcinoloneDrug
Also called Kenalog
Triamcinolone will be injected in the keloid scar 4 mg/cm2 every 4 weeks for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Intralesional Triamcinolone | Active comparator | A dosage of 4mg/cm2 of intralesional triamcinolone will be injected in the keloid scar every 4 weeks during 6 months. Receives: Drug: Intralesional Triamcinolone |
| Topical Pirfenidone | Experimental | Dosage commensurate with scar surface to be treated. After washing and drying the affected area, a thin layer of 8% pirfenidone will be applied on the scar, three times a day, for 6 months. Receives: Drug: Topical Pirfenidone |
| Triamcinolone + Pirfenidone | Experimental | A dosage of 4mg/cm2 of intralesional triamcinolone will be injected in the keloid scar every 4 weeks during 6 months. Simultaneously, a thin layer of 8% pirfenidone will be applied on the scar, three times a day, for 6 months. Receives: Drug: Triamcinolone + Pirfenidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Keloid Scar Assessment
Assessment using the Vancouver Scar Scale (VSS)
Measured: 0 and 24 weeks
Change in Keloid Scar Assessment by Patients
Assessment using the Patient and Observer Scar Assessment Scale (POSAS)
Measured: 0 and 24 weeks
Secondary outcomes (3)
Occurrence of adverse effects
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: Every 4 weeks after the beginning of the intervention up to 52 weeks
Quality of life of the patient
Dermatology Life Quality Index
Measured: 24 weeks
Recurrence defined as an increase size of the keloid scar at week 52
Number of patients with an increase size of the keloid scar compared with the size obtained at week 24
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study start24 Oct 2016
- Primary completion31 Dec 2019 (estimated)
- Study completion1 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Dermatológico Dr. Ladislao de la Pascua
- Sponsor type
- University, hospital or other
- Collaborators
- Grupo Medifarma, S. A. de C. V.
- Responsible party
- Sponsor
- Investigators
- Martha Alejandra Morales-Sánchez, MD, MSc, Principal investigator, Centro Dermatológico Dr. Ladislao de la Pascua
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02823236
- Sponsor's protocol ID
- 90/15
- Acronym
- LADISLAO
- Status last verified
- Jul 2017
- First submitted
- 27 Jun 2016
- Last updated
- 14 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intralesional Triamcinolone and 8% Topical Pirfenidone for Treatment of Keloid Scars: 3-arm Trial
- ClinicalTrials.gov ID
- NCT02823236
- Acronym / sponsor ID
- LADISLAO / 90/15
- Conditions
- Keloid
- Keywords
- Keloid, Scar
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Centro Dermatológico Dr. Ladislao de la PascuaUniversity, hospital or other
- Collaborators
- Grupo Medifarma, S. A. de C. V.
- Study start
- 24 Oct 2016 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 1 May 2020 (estimated)
- First posted
- 6 Jul 2016 (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.
The aim of the study is to assess the efficacy and safety of the combination of intralesional triamcinolone (at doses of 4mg / cm2 at intervals of 4 weeks) and topical pirfenidone 8% (every 8 hours continuously) compared with their isolated application, in the treatment of keloid scars in adults. The duration of this three-arm clinical trial will be 12 months, a 6-month period for treatment and a follow-up of 6 months to assess recurrences. The estimated number of persons to be recruited and randomized for the study is 102.
Detailed description
Individuals with keloid scars will be randomized to 3 arms of treatment in order to assess the efficacy of combining intralesional triamcinolone and topical pirfenidone compared with the isolated application of these drugs. The interventions will last 6 months but the individuals will be assessed monthly to determine recurrences for 6 more months. The scar size will be measure at weeks 12, 24 and 52.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intralesional Triamcinolone | Active comparator | Drug: Intralesional TriamcinoloneA dosage of 4mg/cm2 of intralesional triamcinolone will be injected in the keloid scar every 4 weeks during 6 months. |
| Topical Pirfenidone | Experimental | Drug: Topical PirfenidoneDosage commensurate with scar surface to be treated. After washing and drying the affected area, a thin layer of 8% pirfenidone will be applied on the scar, three times a day, for 6 months. |
| Triamcinolone + Pirfenidone | Experimental | Drug: Triamcinolone + PirfenidoneA dosage of 4mg/cm2 of intralesional triamcinolone will be injected in the keloid scar every 4 weeks during 6 months. Simultaneously, a thin layer of 8% pirfenidone will be applied on the scar, three times a day, for 6 months. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Keloids size equal or major than 1 cm
- Keloids less than 5 years old
- Keloids in trunk
Key exclusion criteria (14 listed)
- Keloid with a surgical indication
- Hypertrophic scars
- Scars after burn wounds
- Pregnancy
- Lactation
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 |
|---|---|---|
| Topical PirfenidoneAlso: KitosCellPirfenidone 8% gel will be applied three times per day during 6 months in the surface of the keloid scar. | Drug | Topical Pirfenidone |
| Triamcinolone + PirfenidoneAlso: Kenalog + KitosCellTriamcinolone will be injected in the keloid scar 4 mg/cm2 every 4 weeks for 6 months. And pirfenidone 8% gel will be applied three times per day during 6 months in the surface of the keloid scar. | Drug | Triamcinolone + Pirfenidone |
| Intralesional TriamcinoloneAlso: KenalogTriamcinolone will be injected in the keloid scar 4 mg/cm2 every 4 weeks for 6 months. | Drug | Intralesional Triamcinolone |
Primary outcome
Change in Keloid Scar Assessment
Time frame: 0 and 24 weeks
Assessment using the Vancouver Scar Scale (VSS)
Change in Keloid Scar Assessment by Patients
Time frame: 0 and 24 weeks
Assessment using the Patient and Observer Scar Assessment Scale (POSAS)
3 secondary outcomes
Occurrence of adverse effects
Time frame: Every 4 weeks after the beginning of the intervention up to 52 weeks
Quality of life of the patient
Time frame: 24 weeks
Recurrence defined as an increase size of the keloid scar at week 52
Time frame: 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2017.
- Individual participant dataSharing planned: Undecided
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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.
Martha Alejandra Morales-Sánchez, MD, MSc principal investigator
Centro Dermatológico Dr. Ladislao de la Pascua
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Topical Pirfenidone, Triamcinolone + Pirfenidone and Intralesional Triamcinolone in people with Keloid, run by Centro Dermatológico Dr. Ladislao de la Pascua at 1 site in Mexico.
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 3 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 14 Jul 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 Mexico. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martha Alejandra Morales-Sánchez, MD, MSc (55387033 ext. 312, mmoraless@sersalud.df.gob.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Keloid Scar Assessment (time frame: 0 and 24 weeks). The study lists 2 primary outcomes in all. 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 14 Jul 2017.