Efficacy of Melanostop Peeling for Improvement of Melasma

Study Overview
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Brief Summary
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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).

Official Title
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The Efficacy of Melanostop Peel in Combination With Specifically Selected Home Care Regimen for Improvement of Melasma

Conditions
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Melasma

Intervention / Treatment
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* Other: Melanostop peel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Melanostop peel treatment group<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | week 1, week 7, week 11 | 
| 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. | week 1, week 7, week 11 | 
| 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. | week 1, week 7, week 11 | 
| 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. | week 1, week 7, week 11 |