Efficacy Study of Two Silicon-based Products to Treat Scars

Scars Clinical Trial

— Kelofin  

Official title:

Comparative, Open, Randomized Trial Between Two Silicon-based Products to Treat Postoperative Scars

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02584010
• Other study ID #: All-M-42361-01-08-14
• Status: Withdrawn
• Phase: N/A
• First received: October 21, 2015
• Last updated: February 14, 2017
• Start date: January 2016
• Est. completion date: October 2016

Study information

• Verified date: February 2017
• Source: Ache Laboratorios Farmaceuticos S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Scars

Intervention

Other:
• Silicon-based aerosol
Apply twice a day over the postoperative scar
• Silicon-based gel
Apply twice a day over the postoperative scar

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ache Laboratorios Farmaceuticos S.A.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Adverse events occurrence	Adverse events will be evaluated since the baseline visit until 180 days after the end of the treatment.	180 days