Efficacy Study of Two Silicon-based Products to Treat Scars
Kelofin
Comparative, Open, Randomized Trial Between Two Silicon-based Products to Treat Postoperative Scars
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
This study aims to determine if a silicon-based gel and a silicon-based aerosol are effective in the treatment of postoperative scars.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2016
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 21, 2015
CompletedFirst Posted
Study publicly available on registry
October 22, 2015
CompletedStudy Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedFebruary 15, 2017
February 1, 2017
6 months
October 21, 2015
February 14, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
180 days
Secondary Outcomes (4)
Evaluation of scars color improvement
180 days
Evaluation of scars measurement improvement
180 days
Participants satisfaction regarding the treatment
180 days
Adverse events occurrence
180 days
Study Arms (3)
Kelofin Aerosol
EXPERIMENTALSilicon-based Aerosol that will be applied over the postoperative scar two times a day
Kelofin Gel
EXPERIMENTALSilicon-based Gel that will be applied over the postoperative scar two times a day
Control
NO INTERVENTIONThis group will not receive any intervention as a control group.
Interventions
Apply twice a day over the postoperative scar
Apply twice a day over the postoperative scar
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 21, 2015
First Posted
October 22, 2015
Study Start
January 1, 2016
Primary Completion
July 1, 2016
Study Completion
October 1, 2016
Last Updated
February 15, 2017
Record last verified: 2017-02