Efficacy Study of Two Silicon-based Products to Treat Scars

NCT ID: NCT02584010

Last Updated: 2017-02-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2016-10-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Kelofin Aerosol

Silicon-based Aerosol that will be applied over the postoperative scar two times a day

Group Type: EXPERIMENTAL

Silicon-based aerosol

Intervention Type: OTHER

Apply twice a day over the postoperative scar

Kelofin Gel

Silicon-based Gel that will be applied over the postoperative scar two times a day

Group Type: EXPERIMENTAL

Silicon-based gel

Intervention Type: OTHER

Apply twice a day over the postoperative scar

Control

This group will not receive any intervention as a control group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Silicon-based aerosol

Apply twice a day over the postoperative scar

Intervention Type: OTHER

Silicon-based gel

Apply twice a day over the postoperative scar

Intervention Type: OTHER

Other Intervention Names

Kelofin Aerosol; Kelofin Gel

Eligibility 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

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ache Laboratorios Farmaceuticos S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

All-M-42361-01-08-14

Identifier Type: -

Identifier Source: org_study_id