Efficacy Study of Two Silicon-based Products to Treat Scars (Kelofin)

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.

Study Overview

• Status: Withdrawn
• Conditions: Scars
• Intervention / Treatment: Other: Silicon-based aerosol; Other: Silicon-based gel

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 Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / 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: Kelofin Aerosol
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: Kelofin Gel
No Intervention: Control; This group will not receive any intervention as a control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	180 days
Adverse events occurrence	Adverse events will be evaluated since the baseline visit until 180 days after the end of the treatment.	180 days

Collaborators and Investigators

• Sponsor: Ache Laboratorios Farmaceuticos S.A.

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Anticipated): July 1, 2016
• Study Completion (Anticipated): October 1, 2016

Study Registration Dates

• First Submitted: October 21, 2015
• First Submitted That Met QC Criteria: October 21, 2015
• First Posted (Estimate): October 22, 2015

Study Record Updates

• Last Update Posted (Actual): February 15, 2017
• Last Update Submitted That Met QC Criteria: February 14, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Cicatrization; Cicatrix; Postoperative scars
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix; Physiological Effects of Drugs; Trace Elements; Micronutrients; Silicon
• Other Study ID Numbers: All-M-42361-01-08-14