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Efficacy of Melanostop Peeling for Improvement of Melasma (VIMEL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03826277
Recruitment Status : Unknown
Verified January 2019 by VIST - Faculty of Applied Sciences.
Recruitment status was:  Not yet recruiting
First Posted : February 1, 2019
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
VIST - Faculty of Applied Sciences

Study Description
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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).

Condition or disease Intervention/treatment Phase
Melasma Other: Melanostop peel Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Efficacy of Melanostop Peel in Combination With Specifically Selected Home Care Regimen for Improvement of Melasma
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : December 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: Melanostop peel treatment group
  • Adult women aged between 20-50 years old.
  • Melasma on the face
  • Fitzpatrick phototypes I-IV
  • Presenting facial melasma
  • In good health condition
 Other: Melanostop peel

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


Outcome Measures
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Primary Outcome Measures :
  1. Modified Melasma Area and Severity Index (mMASI) [ Time Frame: week 1, week 7, week 11 ]

    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


  2. Colour difference [ Time Frame: week 1, week 7, week 11 ]

    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.


  3. Melanin index change [ Time Frame: week 1, week 7, week 11 ]

    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.


  4. Area of the melasma [ Time Frame: week 1, week 7, week 11 ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   women
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03826277


Contacts
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Contact: Anja Batic, BSc 0038612831700 baticanja91@gmail.com
Contact: Katja Žmitek, PhD 0038612831700 kozmetika@vist.si

Locations
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Slovenia
Higher School of Applied Sciences, Institute of Cosmetics
Ljubljana, Slovenia, 1000
Sponsors and Collaborators
VIST - Faculty of Applied Sciences
Investigators
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Study Chair: Katja Žmitek, PhD Head of Reasearch Group
More Information
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Responsible Party: VIST - Faculty of Applied Sciences
ClinicalTrials.gov Identifier: NCT03826277    
Other Study ID Numbers: 19/1-SK-KPS
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Melanosis
Hyperpigmentation
Pigmentation Disorders
Skin Diseases