ScarsPhase 3NCT06909812
Silicone vs Pirfenidone in the Treatment of Hypertrophic Scars and Keloids
A Phase 3 study testing pirfenidone 8% gel and silicon gel in people with Scars and Keloids, run by Fundación Nacional para la Enseñanza y la Investigación de la Dermatología A.C. at 1 site in Mexico.
Trial summary
Justification: Keloid scars are a major medical and cosmetic problem, especially in darker skin types that predominate in Mexico. It is estimated that hypertrophic scars affecting from 1.5 to 4.5% of the general population. However, the exact prevalence is unknown but studies show that going from 32 to 67%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scars, Keloids, Hypertrophic Scar
- What is being tested?
- pirfenidone 8% gel and silicon gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteMexico
- Study dates
- 14 Jul 2015to 20 Jan 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- keloid or hypetrophic scar
Who cannot join
- collagen diseases pregnancy previous treatment for 3 months
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital General Manuel Gea González
Mexico City, Mexico City, 01710
About this study
Official title: A Observer Blind Randomized Controlled Pilot Trial to Determine the Equivalence of a Silicone Gel With Superoxidized Water vs. a Pirfenidone Gel for the Treatment of Hypertrophic Scars and Keloids
Justification:
Keloid scars are a major medical and cosmetic problem, especially in darker skin types that predominate in Mexico. It is estimated that hypertrophic scars affecting from 1.5 to 4.5% of the general population. However, the exact prevalence is unknown but studies show that going from 32 to 67%. And there are studies documenting that this prevalence is higher in Hispanic and black individuals and in the pediatric population.
Read more
Keloid scars can become highly symptomatic disfiguring and which affects the quality of life of patients and their self-esteem.Problem Statement:
Is silicone gel solutions superoxidation with equal or better than the gel 8% pirfenidone to treat keloids and hypertrophic scars?
Goal:
To evaluate the efficacy of a silicone gel-oxidation with solutions compared to a gel containing 8% pirfenidone.
Hypothesis:
If the silicone gel solutions superoxidation is equal or better than gel 8% pirfenidone to treat keloids and hypertrophic scars, then the reduction in the ECV and the EVA will be similar in the first group than the second.
Design:
Comparative, observer blind, experimental and prospective study.
Read the detailed description
This is a comparative, non-inferiority, experimental, prospective, longitudinal pilot study with blind evaluator, in patients with keloid or hypertrophic scars. Twenty patients per group randomly assigned to receive identical tubes of either a silicone-based gel with superoxidized water, or an 8% pirfenidone gel. Follow-up was scheduled at 2, 4, 8, 12, and 16 weeks recording the location, mechanism of the scar, time of evolution, skin phototype, accompanying symptoms, Dermatology Life Quality Index, and validated scar assessment tools (Patient and Observer Scar Assessment Scale, Vancouver Scar Scale, and the Analog Visual Scale for Keloids).
- Conditions
- Scars, Keloids, Hypertrophic Scar
- Being tested
- pirfenidone 8% gel, silicon gel
- Keywords
- scars, keloids, hyperthrophic, pirfenidone
- Medical subject headings
- Cicatrix, Keloid, Cicatrix, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pirfenidone 8% gelDrug
Also called kitoscell
topic aplication
silicon gelDrug
Also called Kelodacyn
topic aplication
| Study group | Role | What they receive |
|---|---|---|
| Topical Silicone Gel | Active comparator | A gel containing silicone Receives: Drug: silicon gel |
| Topical Pirfenidone Gel | Active comparator | A gel containing pirfenidone Receives: Drug: pirfenidone 8% gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dermatology Life Quality Index Score
A life quality index for dermatological conditions
Measured: 3 months
Patient and Observer Scar Assessment Scale Score
A validated scale (POSAS and OSAS) to assess relevant clinical characteristics of scars.
Measured: 3 months
Vancouver Scar Scale
A validated scar scale
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start14 Jul 2015
- Primary completion20 Jan 2016
- Study completion20 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScarsStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Nacional para la Enseñanza y la Investigación de la Dermatología A.C.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jose Contreras-Ruiz, Principal investigator, Hospital General Dr Manuel Gea Gonzalez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06909812
- Sponsor's protocol ID
- FNEIDAC_Keloids_K131672
- Status last verified
- Mar 2025
- First submitted
- 30 Jul 2015
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Observer Blind Randomized Controlled Pilot Trial to Determine the Equivalence of a Silicone Gel With Superoxidized Water vs. a Pirfenidone Gel for the Treatment of Hypertrophic Scars and Keloids
- ClinicalTrials.gov ID
- NCT06909812
- Acronym / sponsor ID
- FNEIDAC_Keloids_K131672
- Conditions
- Scars, Keloids, Hypertrophic Scar
- Keywords
- scars, keloids, hyperthrophic, pirfenidone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Fundación Nacional para la Enseñanza y la Investigación de la Dermatología A.C.University, hospital or other
- Study start
- 14 Jul 2015 (actual)
- Primary completion
- 20 Jan 2016 (actual)
- Study completion
- 20 Jan 2016 (actual)
- First posted
- 4 Apr 2025 (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.
Justification:
Keloid scars are a major medical and cosmetic problem, especially in darker skin types that predominate in Mexico. It is estimated that hypertrophic scars affecting from 1.5 to 4.5% of the general population. However, the exact prevalence is unknown but studies show that going from 32 to 67%. And there are studies documenting that this prevalence is higher in Hispanic and black individuals and in the pediatric population.
Keloid scars can become highly symptomatic disfiguring and which affects the quality of life of patients and their self-esteem.Problem Statement:
Is silicone gel solutions superoxidation with equal or better than the gel 8% pirfenidone to treat keloids and hypertrophic scars?
Goal:
To evaluate the efficacy of a silicone gel-oxidation with solutions compared to a gel containing 8% pirfenidone.
Hypothesis:
If the silicone gel solutions superoxidation is equal or better than gel 8% pirfenidone to treat keloids and hypertrophic scars, then the reduction in the ECV and the EVA will be similar in the first group than the second.
Design:
Comparative, observer blind, experimental and prospective study.
Detailed description
This is a comparative, non-inferiority, experimental, prospective, longitudinal pilot study with blind evaluator, in patients with keloid or hypertrophic scars. Twenty patients per group randomly assigned to receive identical tubes of either a silicone-based gel with superoxidized water, or an 8% pirfenidone gel. Follow-up was scheduled at 2, 4, 8, 12, and 16 weeks recording the location, mechanism of the scar, time of evolution, skin phototype, accompanying symptoms, Dermatology Life Quality Index, and validated scar assessment tools (Patient and Observer Scar Assessment Scale, Vancouver Scar Scale, and the Analog Visual Scale for Keloids).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical Silicone Gel | Active comparator | Drug: silicon gelA gel containing silicone |
| Topical Pirfenidone Gel | Active comparator | Drug: pirfenidone 8% gelA gel containing pirfenidone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- keloid or hypetrophic scar
Key exclusion criteria (1 listed)
- collagen diseases pregnancy previous treatment for 3 months
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 8% gelAlso: kitoscelltopic aplication | Drug | Topical Pirfenidone Gel |
| silicon gelAlso: Kelodacyntopic aplication | Drug | Topical Silicone Gel |
Primary outcome
Dermatology Life Quality Index Score
Time frame: 3 months
A life quality index for dermatological conditions
Patient and Observer Scar Assessment Scale Score
Time frame: 3 months
A validated scale (POSAS and OSAS) to assess relevant clinical characteristics of scars.
Vancouver Scar Scale
Time frame: 3 months
A validated scar scale
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 4 Apr 2025.
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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.
Jose Contreras-Ruiz principal investigator
Hospital General Dr Manuel Gea Gonzalez
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 pirfenidone 8% gel and silicon gel in people with Scars and Keloids, run by Fundación Nacional para la Enseñanza y la Investigación de la Dermatología A.C. 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 1 inclusion and 1 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 4 Apr 2025. 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?
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?
Dermatology Life Quality Index Score (time frame: 3 months). The study lists 3 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 4 Apr 2025.