Efficacy of Melanostop Peeling for Improvement of Melasma

NCT03826277 | Unknown

• 1 other identifier: 19/1-SK-KPS
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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).

Conditions

Melasma

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

Melanostop peel treatment group

EXPERIMENTAL

* 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

Interventions

Melanostop peel OTHER

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

Melanostop peel treatment group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Gender Eligibility Details: women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• VIST - Faculty of Applied Sciences: lead

Study Sites (1)

Higher School of Applied Sciences, Institute of Cosmetics

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Melanosis

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Katja Žmitek, PhD

  Head of Reasearch Group

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2019
• First Posted: February 1, 2019
• Study Start: February 1, 2019
• Primary Completion: August 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 26, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)