An interventional study of Melanostop peel in Melasma, sponsored by VIST - Faculty of Applied Sciences. Status unknown at 1 site in Slovenia. Open to female participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-26.
Sponsored by VIST - Faculty of Applied Sciences · Not applicable, Interventional, and Supportive care
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).
159 studies on the registry are indexed under Melanosis; 42 are open to participants now.
This study's enrollment of 10 is below the median of 40 across 149 interventional studies indexed under Melanosis.
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Exclusion Criteria:
* 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
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
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: week 1, week 7, week 11
Plan to share: No
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This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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VIST - Faculty of Applied Sciences