Efficacy Study of Two Silicon-based Products to Treat Scars

Ache Laboratorios Farmaceuticos S.A.

Overview

This study aims to determine if a silicon-based gel and a silicon-based aerosol are effective in the treatment of postoperative scars.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Scars

Interventions

Silicon-based aerosolOTHER

Apply twice a day over the postoperative scar

Silicon-based gelOTHER

Apply twice a day over the postoperative scar

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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: * 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.

Outcomes

Primary Outcomes

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.

Time frame: 180 days

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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

Time frame: 180 days

Adverse events occurrence

Adverse events will be evaluated since the baseline visit until 180 days after the end of the treatment.

Time frame: 180 days

Data from ClinicalTrials.gov

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