Efficacy of Melanostop Peeling for Improvement of Melasma (VIMEL)

VIST - Faculty of Applied Sciences

Status: Active, not recruiting

Conditions: Melasma

Treatments: Other: Melanostop peel

Study type: Interventional

Funder types: Other

Identifiers

NCT03826277

19/1-SK-KPS

Details and patient eligibility

About

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).

Enrollment: 10 patients

Sex: Female

Ages: 20 to 50 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Melanostop peel treatment group

Experimental group

Description:

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

Treatment:

Other: Melanostop peel