ScarsKelofinNCT02584010
Efficacy Study of Two Silicon-based Products to Treat Scars
A study testing Silicon-based aerosol and Silicon-based gel in people with Scars, run by Ache Laboratorios Farmaceuticos S.A..
Trial summary
This study aims to determine if a silicon-based gel and a silicon-based aerosol are effective in the treatment of postoperative scars. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Scars
- What is being tested?
- Silicon-based aerosol and Silicon-based gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Oct 2016
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fitzpatrick skin phototype I, II, III or IV
- Participant that has a recent surgical scar on remodeling phase (14 ± 7 days after surgery) from the following: breast plastic with inframammary incision (fold beneath the breast) or abdominoplasty, cesarean section, hysterectomy (removal of the uterus), oophorectomy (removal of ovaries), oophoroplasty (removal of nodules, cysts, etc. of the ovaries), salpingectomy (removal of the fallopian tubes), tubal ligation, exploratory laparotomy and ectopic pregnancy (pregnancy outside the uterus) (Pfannenstiel access road - transverse incision , below the navel and approximately one finger above the symphysis pubis).
Who cannot join
- Skin Pathology in the product application area;
- Diabetes;
- Immune impairment;
- Use of systemic corticosteroids or immunosuppressants;
- Skin diseases: vitiligo, psoriasis, lupus, atopic dermatitis;
- Background reaction to silicon-based products;
- Other illnesses or medications that may interfere directly in the study or endanger the health of the participant.
About this study
Official title: Comparative, Open, Randomized Trial Between Two Silicon-based Products to Treat Postoperative Scars
This study aims to determine if a silicon-based gel and a silicon-based aerosol are effective in the treatment of postoperative scars.
Read the detailed description
Improve the final aspect of scars, have been a challenge for medicine. Silicon based products have been used in various ways to prevent hypertrophic scars and keloids since 1980. A great percentage of studies shows that silicon-based products improves the aspect of scars in different pathologies. The main objective of this trial is to evaluate the efficacy, using the Vancouver scale, of two silicon-based products (Kelofin gel and Kelofin aerosol) after 180 days.
300 participants that meet all the inclusion criteria and are not classified in any of the exclusion criteria will be randomly allocated to one of thre treatment groups( Kelofin Gel, Kelofin Aerosol and no treatment) of the study.
- Conditions
- Scars
- Being tested
- Silicon-based aerosol, Silicon-based gel
- Keywords
- Postoperative scars, Cicatrix, Cicatrization
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silicon-based aerosolOther
Also called Kelofin Aerosol
Apply twice a day over the postoperative scar
Silicon-based gelOther
Also called Kelofin Gel
Apply twice a day over the postoperative scar
| Study group | Role | What they receive |
|---|---|---|
| Kelofin Aerosol | Experimental | Silicon-based Aerosol that will be applied over the postoperative scar two times a day Receives: Other: Silicon-based aerosol |
| Kelofin Gel | Experimental | Silicon-based Gel that will be applied over the postoperative scar two times a day Receives: Other: Silicon-based gel |
| Control | No intervention | This group will not receive any intervention as a control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of scars clinical improvement
The scars will be evaluated by the Vancouver scale since the baseline visit until 180 days after the end of the treatment.
Measured: 180 days
Secondary outcomes (4)
Evaluation of scars color improvement
The scars will be evaluated by the equipment Mexameter (Courage+Khazaka®) since the baseline visit until 180 days after the end of the treatment.
Measured: 180 days
Evaluation of scars measurement improvement
The scars will be evaluated by the equipment Optical 3D Skin Measuring Device PRIMOS Compact 5.075, since the baseline visit until 180 days after the end of the treatment.
Measured: 180 days
Participants satisfaction regarding the treatment
Assess the satisfaction of participants regarding the treatment on each visit using a questionnaire on improving the healing process
Measured: 180 days
Adverse events occurrence
Adverse events will be evaluated since the baseline visit until 180 days after the end of the treatment.
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2015 (estimated)
- Study startJan 2016
- Primary completionJul 2016 (estimated)
- Study completionOct 2016 (estimated)
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ache Laboratorios Farmaceuticos S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02584010
- Sponsor's protocol ID
- All-M-42361-01-08-14
- Acronym
- Kelofin
- Status last verified
- Feb 2017
- First submitted
- 21 Oct 2015
- Last updated
- 15 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative, Open, Randomized Trial Between Two Silicon-based Products to Treat Postoperative Scars
- ClinicalTrials.gov ID
- NCT02584010
- Acronym / sponsor ID
- Kelofin / All-M-42361-01-08-14
- Conditions
- Scars
- Keywords
- Postoperative scars, Cicatrix, Cicatrization
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ache Laboratorios Farmaceuticos S.A.Industry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 22 Oct 2015 (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 study aims to determine if a silicon-based gel and a silicon-based aerosol are effective in the treatment of postoperative scars.
Detailed description
Improve the final aspect of scars, have been a challenge for medicine. Silicon based products have been used in various ways to prevent hypertrophic scars and keloids since 1980. A great percentage of studies shows that silicon-based products improves the aspect of scars in different pathologies. The main objective of this trial is to evaluate the efficacy, using the Vancouver scale, of two silicon-based products (Kelofin gel and Kelofin aerosol) after 180 days.
300 participants that meet all the inclusion criteria and are not classified in any of the exclusion criteria will be randomly allocated to one of thre treatment groups( Kelofin Gel, Kelofin Aerosol and no treatment) of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Kelofin Aerosol | Experimental | Other: Silicon-based aerosolSilicon-based Aerosol that will be applied over the postoperative scar two times a day |
| Kelofin Gel | Experimental | Other: Silicon-based gelSilicon-based Gel that will be applied over the postoperative scar two times a day |
| Control | No intervention | –This group will not receive any intervention as a control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Fitzpatrick skin phototype I, II, III or IV
- Participant that has a recent surgical scar on remodeling phase (14 ± 7 days after surgery) from the following: breast plastic with inframammary incision (fold beneath the breast) or abdominoplasty, cesarean section, hysterectomy (removal of the uterus), oophorectomy (removal of ovaries), oophoroplasty (removal of nodules, cysts, etc. of the ovaries), salpingectomy (removal of the fallopian tubes), tubal ligation, exploratory laparotomy and ectopic pregnancy (pregnancy outside the uterus) (Pfannenstiel access road - transverse incision , below the navel and approximately one finger above the symphysis pubis).
Key exclusion criteria (7 listed)
- Skin Pathology in the product application area;
- Diabetes;
- Immune impairment;
- Use of systemic corticosteroids or immunosuppressants;
- Skin diseases: vitiligo, psoriasis, lupus, atopic dermatitis;
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 |
|---|---|---|
| Silicon-based aerosolAlso: Kelofin AerosolApply twice a day over the postoperative scar | Other | Kelofin Aerosol |
| Silicon-based gelAlso: Kelofin GelApply twice a day over the postoperative scar | Other | Kelofin Gel |
Primary outcome
Evaluation of scars clinical improvement
Time frame: 180 days
The scars will be evaluated by the Vancouver scale since the baseline visit until 180 days after the end of the treatment.
4 secondary outcomes
Evaluation of scars color improvement
Time frame: 180 days
Evaluation of scars measurement improvement
Time frame: 180 days
Participants satisfaction regarding the treatment
Time frame: 180 days
Adverse events occurrence
Time frame: 180 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Silicon-based aerosol and Silicon-based gel in people with Scars, run by Ache Laboratorios Farmaceuticos S.A..
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 2 inclusion and 7 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: withdrawn, as of the sponsor's last update on 15 Feb 2017. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Evaluation of scars clinical improvement (time frame: 180 days). 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 Feb 2017.