Efficacy of Melanostop Peeling for Improvement of Melasma

NCT ID: NCT03826277

Last Updated: 2023-04-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2024-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Melanostop peel

Intervention Type: 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

Interventions

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

VIST - Faculty of Applied Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Katja Žmitek, PhD

Role: STUDY_CHAIR

Head of Reasearch Group

Locations

Higher School of Applied Sciences, Institute of Cosmetics

Ljubljana, , Slovenia

Countries

Slovenia

Other Identifiers

19/1-SK-KPS

Identifier Type: -

Identifier Source: org_study_id