Efficacy Study of Two Silicon-based Products to Treat Scars

Not Applicable

Withdrawn

• Conditions: Scars
• Interventions: Other: Silicon-based gel; Other: Silicon-based aerosol

• Registration Number: NCT02584010
• Lead Sponsor: Ache Laboratorios Farmaceuticos S.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.

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 Timeline

• Study First Submitted: 2015-10-21
• Study First Submitted QC: 2015-10-21
• Study First Posted: 2015-10-22
• Study Start: 2016-01
• Primary Completion: 2016-07
• Study Completion: 2016-10
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-14
• Last Update Posted: 2017-02-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Kelofin Gel	Silicon-based gel	Silicon-based Gel that will be applied over the postoperative scar two times a day
Kelofin Aerosol	Silicon-based aerosol	Silicon-based Aerosol that will be applied over the postoperative scar two times a day

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
Adverse events occurrence	180 days	Adverse events will be evaluated 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