Kelofin: Efficacy Study of Two Silicon-based Products to Treat Scars
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Kelofin Aerosol Silicon-based Aerosol that will be applied over the postoperative scar two times a day |
Other: Silicon-based aerosol
Apply twice a day over the postoperative scar
Other Names:
|
| Experimental: Kelofin Gel Silicon-based Gel that will be applied over the postoperative scar two times a day |
Other: Silicon-based gel
Apply twice a day over the postoperative scar
Other Names:
|
| No Intervention: Control This group will not receive any intervention as a control group. |
Outcome Measures
Primary Outcome Measures
- Evaluation of scars clinical improvement [180 days]
The scars will be evaluated by the Vancouver scale since the baseline visit until 180 days after the end of the treatment.
Secondary Outcome Measures
- Evaluation of scars color improvement [180 days]
The scars will be evaluated by the equipment Mexameter (Courage+Khazaka®) since the baseline visit until 180 days after the end of the treatment.
- Evaluation of scars measurement improvement [180 days]
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.
- Participants satisfaction regarding the treatment [180 days]
Assess the satisfaction of participants regarding the treatment on each visit using a questionnaire on improving the healing process
- Adverse events occurrence [180 days]
Adverse events will be evaluated since the baseline visit until 180 days after the end of the treatment.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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).
Exclusion Criteria:
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Skin Pathology in the product application area;
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Diabetes;
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Immune impairment;
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Use of systemic corticosteroids or immunosuppressants;
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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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Ache Laboratorios Farmaceuticos S.A.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- All-M-42361-01-08-14