Efficacy of Melanostop Peeling for Improvement of Melasma (VIMEL)
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|ClinicalTrials.gov Identifier: NCT03826277|
Recruitment Status : Unknown
Verified January 2019 by VIST - Faculty of Applied Sciences.
Recruitment status was: Not yet recruiting
First Posted : February 1, 2019
Last Update Posted : February 15, 2019
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|Condition or disease||Intervention/treatment||Phase|
|Melasma||Other: Melanostop peel||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||The Efficacy of Melanostop Peel in Combination With Specifically Selected Home Care Regimen for Improvement of Melasma|
|Estimated Study Start Date :||February 2019|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: Melanostop peel treatment group
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):
- Modified Melasma Area and Severity Index (mMASI) [ Time Frame: 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
- Colour difference [ Time Frame: 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.
- Melanin index change [ Time Frame: 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.
- Area of the melasma [ Time Frame: 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.
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|Ages Eligible for Study:||20 Years to 50 Years (Adult)|
|Sexes Eligible for Study:||Female|
|Gender Based Eligibility:||Yes|
|Gender Eligibility Description:||women|
|Accepts Healthy Volunteers:||Yes|
- Adult women aged between 20-50 years old.
- Melasma on the face
- Fitzpatrick phototypes I-IV
- Presenting facial melasma
- In good health condition
- 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
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03826277
|Contact: Anja Batic, BScfirstname.lastname@example.org|
|Contact: Katja Žmitek, PhDemail@example.com|
|Higher School of Applied Sciences, Institute of Cosmetics|
|Ljubljana, Slovenia, 1000|
|Study Chair:||Katja Žmitek, PhD||Head of Reasearch Group|
|Responsible Party:||VIST - Faculty of Applied Sciences|
|Other Study ID Numbers:||
|First Posted:||February 1, 2019 Key Record Dates|
|Last Update Posted:||February 15, 2019|
|Last Verified:||January 2019|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|