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

Primary Purpose

Scars

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Silicon-based aerosol
Silicon-based gel
Sponsored by
Ache Laboratorios Farmaceuticos S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scars focused on measuring Postoperative scars, Cicatrix, Cicatrization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    Kelofin Aerosol

    Kelofin Gel

    Control

    Arm Description

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

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

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.
    Participants satisfaction regarding the treatment
    Assess the satisfaction of participants regarding the treatment on each visit using a questionnaire on improving the healing process
    Adverse events occurrence
    Adverse events will be evaluated since the baseline visit until 180 days after the end of the treatment.

    Full Information

    First Posted
    October 21, 2015
    Last Updated
    February 14, 2017
    Sponsor
    Ache Laboratorios Farmaceuticos S.A.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02584010
    Brief Title
    Efficacy Study of Two Silicon-based Products to Treat Scars
    Acronym
    Kelofin
    Official Title
    Comparative, Open, Randomized Trial Between Two Silicon-based Products to Treat Postoperative Scars
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    January 2016 (undefined)
    Primary Completion Date
    July 2016 (Anticipated)
    Study Completion Date
    October 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Ache Laboratorios Farmaceuticos S.A.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Scars
    Keywords
    Postoperative scars, Cicatrix, Cicatrization

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Kelofin Aerosol
    Arm Type
    Experimental
    Arm Description
    Silicon-based Aerosol that will be applied over the postoperative scar two times a day
    Arm Title
    Kelofin Gel
    Arm Type
    Experimental
    Arm Description
    Silicon-based Gel that will be applied over the postoperative scar two times a day
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    This group will not receive any intervention as a control group.
    Intervention Type
    Other
    Intervention Name(s)
    Silicon-based aerosol
    Other Intervention Name(s)
    Kelofin Aerosol
    Intervention Description
    Apply twice a day over the postoperative scar
    Intervention Type
    Other
    Intervention Name(s)
    Silicon-based gel
    Other Intervention Name(s)
    Kelofin Gel
    Intervention Description
    Apply twice a day over the postoperative scar
    Primary Outcome Measure Information:
    Title
    Evaluation of scars clinical improvement
    Description
    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 Outcome Measure Information:
    Title
    Evaluation of scars color improvement
    Description
    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
    Title
    Evaluation of scars measurement improvement
    Description
    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
    Title
    Participants satisfaction regarding the treatment
    Description
    Assess the satisfaction of participants regarding the treatment on each visit using a questionnaire on improving the healing process
    Time Frame
    180 days
    Title
    Adverse events occurrence
    Description
    Adverse events will be evaluated since the baseline visit until 180 days after the end of the treatment.
    Time Frame
    180 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.

    12. IPD Sharing Statement

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    Efficacy Study of Two Silicon-based Products to Treat Scars

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