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Efficacy of Melanostop Peeling for Improvement of Melasma (VIMEL)

Primary Purpose

Melasma

Status
Active
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
Melanostop peel
Sponsored by
VIST - Faculty of Applied Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Melasma

Eligibility Criteria

20 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Adult women aged between 20-50 years old.
  • Melasma on the face
  • Fitzpatrick phototypes I-IV
  • Presenting facial melasma
  • In good health condition

Exclusion Criteria:

  • Breastfeeding and pregnancy
  • Women presenting oral herpes
  • Other skin diseases, arthritis, diabetes, diseases of thyroid gland
  • Any known allergies to ingredients of the products used in the study
  • Systemic or topical use of corticosteroids in the previous 6 months
  • Antiaging or lightening cosmetic/estetic procedures in the last 2 months (for example: laser or IPL treatments, chemical peels,..)
  • Taking drugs for skin lightening in the previous 2 months
  • Smoking
  • Lesions of unknown origin
  • Oral or topical use of isotretinoin in the previous 6 months
  • Active bacterial, viral or fungal infections of the skin
  • Presence of keloid scars
  • Immunodeficiency
  • Moderate to severe acne
  • Planned change in hormonal contraception or taking drugs that have an affect on hormonal balance during the course of the study
  • Unrealistic expectations
  • Refusal to use sunscreen protection and complying with instructions

Sites / Locations

  • Higher School of Applied Sciences, Institute of Cosmetics

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Melanostop peel treatment group

Arm Description

Adult women aged between 20-50 years old. Melasma on the face Fitzpatrick phototypes I-IV Presenting facial melasma In good health condition

Outcomes

Primary Outcome Measures

Modified Melasma Area and Severity Index (mMASI)
Melasma severity will be evaluated according to Modified Melasma Area and Severity Index (mMASI). Significant change of the mMASI score from baseline is expected bfore 4th and one month after 4th Melanostop peel treatments. mMASI score is calculated by first assesing the hyperpigmented area of the face. Four areas are evaluated: forehead (F), right malar region (RM), left malar region(LM), and chin (C), corresponding to 30%, 30%, 30% and 10% of the total face. The melasma in each of the four areas is given a numerical value by rating darkness (D) and area of involvement (A). Scoring system: Area of involvement (A), rated 0 to 6: 0= absent; 1 = <10%; 2 = 10% to 29%; 3 = 30% to 49%; 4= 50% to 69%; 5= 70% to 89%; 6= 90% to 100%. Darkness (D), rated 0 to 4: 0= absent; 1= slight; 2= mild; 3= marked; 4= severe. mMASI total score = (0,3 x A(F) x D(F) ) + (0,3 x A(LM) x D(LM)) + (0,3 x A(RM) x D(RM)) + (0,1 x A(C) x D(C)) Total mMASI score range: 0 - 24
Colour difference
CIE Lab colour will be measured within the lesion and on the control area outside of the lesion using Cortex Dermalab Combo and colour difference (delta E) will be calculated between the areas and in comparison to baseline values. Significant change of the melasma colour from baseline and in comparison to control area is expected after 4 Melanostop peel treatments.
Melanin index change
Melanin index will be measured within the lesion and on the control area outside of the lesion using Cortex Dermalab Combo Skin colour probe. Melanin index is given on a scale 0.0-99.9. Significant change of the melanin index from baseline and in comparison to control area is expected before 4th Melanostop peel treatments and 4 weeks after last treatment.
Area of the melasma
Melasma area will be measured using Visioface photography analysis. Significant change of the melasma area from baseline is expected before 4th Melanostop peel treatments and 4 weeks after last treatment.

Secondary Outcome Measures

Full Information

First Posted
January 30, 2019
Last Updated
April 25, 2023
Sponsor
VIST - Faculty of Applied Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03826277
Brief Title
Efficacy of Melanostop Peeling for Improvement of Melasma
Acronym
VIMEL
Official Title
The Efficacy of Melanostop Peel in Combination With Specifically Selected Home Care Regimen for Improvement of Melasma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VIST - Faculty of Applied Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Participants with face melasma will receive 4 Melanostop peel treatments containing 20% azelaic acid, 10% resorcinol and 6% phytic acid. Peels will be performed at 2-week interval. They will also receive a facial tonic and cream for at home use, containing brightening ingredients: vitamin C, niacinamide, alpha arbutin, kojic acid. They will also receive sunscreen protection cream with SPF 50, protecting against UVA, UVB, HEV and IR. Products for at home use will be used twice a day, every day. Measurements will be made at baseline, on the day of the forth peel treatment and 4 weeks after the last peel. Measured parameters will be: mMASI score, VisioFace photography analysis, melasma area measurements, and melanin index, ΔE, CIELab colour measurements with Cortex SkinLab Combo (Cortex Technology Asp, Denmark).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melasma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Melanostop peel treatment group
Arm Type
Experimental
Arm Description
Adult women aged between 20-50 years old. Melasma on the face Fitzpatrick phototypes I-IV Presenting facial melasma In good health condition
Intervention Type
Other
Intervention Name(s)
Melanostop peel
Intervention Description
Melanostop peel treatments containing 20% azelaic acid, 10% resorcinol, 6% phytic acid, 3% tranexamic acid. (4 treatments, performed at 2-week intervals), in combination with home care products (twice daily): a facial tonic and cream containing brightening ingredients: vitamin C, niacinamide, alpha arbutin, kojic acid, sunscreen protection cream with SPF 50, protecting against UVA, UVB, HEV and IR
Primary Outcome Measure Information:
Title
Modified Melasma Area and Severity Index (mMASI)
Description
Melasma severity will be evaluated according to Modified Melasma Area and Severity Index (mMASI). Significant change of the mMASI score from baseline is expected bfore 4th and one month after 4th Melanostop peel treatments. mMASI score is calculated by first assesing the hyperpigmented area of the face. Four areas are evaluated: forehead (F), right malar region (RM), left malar region(LM), and chin (C), corresponding to 30%, 30%, 30% and 10% of the total face. The melasma in each of the four areas is given a numerical value by rating darkness (D) and area of involvement (A). Scoring system: Area of involvement (A), rated 0 to 6: 0= absent; 1 = <10%; 2 = 10% to 29%; 3 = 30% to 49%; 4= 50% to 69%; 5= 70% to 89%; 6= 90% to 100%. Darkness (D), rated 0 to 4: 0= absent; 1= slight; 2= mild; 3= marked; 4= severe. mMASI total score = (0,3 x A(F) x D(F) ) + (0,3 x A(LM) x D(LM)) + (0,3 x A(RM) x D(RM)) + (0,1 x A(C) x D(C)) Total mMASI score range: 0 - 24
Time Frame
week 1, week 7, week 11
Title
Colour difference
Description
CIE Lab colour will be measured within the lesion and on the control area outside of the lesion using Cortex Dermalab Combo and colour difference (delta E) will be calculated between the areas and in comparison to baseline values. Significant change of the melasma colour from baseline and in comparison to control area is expected after 4 Melanostop peel treatments.
Time Frame
week 1, week 7, week 11
Title
Melanin index change
Description
Melanin index will be measured within the lesion and on the control area outside of the lesion using Cortex Dermalab Combo Skin colour probe. Melanin index is given on a scale 0.0-99.9. Significant change of the melanin index from baseline and in comparison to control area is expected before 4th Melanostop peel treatments and 4 weeks after last treatment.
Time Frame
week 1, week 7, week 11
Title
Area of the melasma
Description
Melasma area will be measured using Visioface photography analysis. Significant change of the melasma area from baseline is expected before 4th Melanostop peel treatments and 4 weeks after last treatment.
Time Frame
week 1, week 7, week 11

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
women
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adult women aged between 20-50 years old. Melasma on the face Fitzpatrick phototypes I-IV Presenting facial melasma In good health condition Exclusion Criteria: Breastfeeding and pregnancy Women presenting oral herpes Other skin diseases, arthritis, diabetes, diseases of thyroid gland Any known allergies to ingredients of the products used in the study Systemic or topical use of corticosteroids in the previous 6 months Antiaging or lightening cosmetic/estetic procedures in the last 2 months (for example: laser or IPL treatments, chemical peels,..) Taking drugs for skin lightening in the previous 2 months Smoking Lesions of unknown origin Oral or topical use of isotretinoin in the previous 6 months Active bacterial, viral or fungal infections of the skin Presence of keloid scars Immunodeficiency Moderate to severe acne Planned change in hormonal contraception or taking drugs that have an affect on hormonal balance during the course of the study Unrealistic expectations Refusal to use sunscreen protection and complying with instructions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katja Žmitek, PhD
Organizational Affiliation
Head of Reasearch Group
Official's Role
Study Chair
Facility Information:
Facility Name
Higher School of Applied Sciences, Institute of Cosmetics
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy of Melanostop Peeling for Improvement of Melasma

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