Efficacy of Melanostop Peeling for Improvement of Melasma

只有注册用户可以翻译文章

登陆注册

链接已保存到剪贴板

状态尚未招聘

赞助商

Higher School of Applied Sciences (VIST)

临床试验: NCT03826277

BioSeek: nct03826277

关键词

抽象

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).

日期

最后验证:	12/31/2018
首次提交:	01/29/2019
提交的预估入学人数:	01/29/2019
首次发布:	01/31/2019
上次提交的更新:	02/11/2019
最近更新发布:	02/14/2019
实际学习开始日期:	01/31/2019
预计主要完成日期:	07/31/2019
预计完成日期:	11/30/2019

状况或疾病

Melasma

干预/治疗

Other: Melanostop peel treatment group

相

手臂组

臂	干预/治疗
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 treatment group 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

臂

干预/治疗

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 treatment group

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

资格标准

有资格学习的年龄	20 Years 至 20 Years
有资格学习的性别	Female
接受健康志愿者	是
标准	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

结果

主要结果指标

1. Modified Melasma Area and Severity Index (mMASI) [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 [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 [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 [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.

Efficacy of Melanostop Peeling for Improvement of Melasma

关键词

melasma

niacinamide

phytic acid

resorcinol

melanin

melanosis

arbutin

azelaic acid

补品

抽象

日期

状况或疾病

干预/治疗

相

手臂组

资格标准

结果

科学支持的最完整的草药数据库