MelasmaVIMELNCT03826277
Efficacy of Melanostop Peeling for Improvement of Melasma
A study testing Melanostop peel in people with Melasma, run by VIST - Faculty of Applied Sciences at 1 site in Slovenia.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Melasma
- What is being tested?
- Melanostop peel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Feb 2019to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult women aged between 20-50 years old.
- Melasma on the face
- Fitzpatrick phototypes I-IV
- Presenting facial melasma
- In good health condition
Who cannot join
- 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,..)
Show all 17Show fewer
- 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 locations and contacts
1 site in 1 country.
Slovenia1 site
Higher School of Applied Sciences, Institute of Cosmetics
Ljubljana, 1000
About this study
Official title: The Efficacy of Melanostop Peel in Combination With Specifically Selected Home Care Regimen for Improvement of Melasma
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
- Being tested
- Melanostop peel
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melanostop peelOther
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
| Study group | Role | What they receive |
|---|---|---|
| Melanostop peel treatment group | Experimental | * Adult women aged between 20-50 years old.
* Melasma on the face
* Fitzpatrick phototypes I-IV
* Presenting facial melasma
* In good health condition Receives: Other: Melanostop peel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: week 1, week 7, week 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start1 Feb 2019
- Primary completionAug 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelasmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- VIST - Faculty of Applied Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katja Žmitek, PhD, Study chair, Head of Reasearch Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03826277
- Sponsor's protocol ID
- 19/1-SK-KPS
- Acronym
- VIMEL
- Status last verified
- Apr 2023
- First submitted
- 30 Jan 2019
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Melanostop Peel in Combination With Specifically Selected Home Care Regimen for Improvement of Melasma
- ClinicalTrials.gov ID
- NCT03826277
- Acronym / sponsor ID
- VIMEL / 19/1-SK-KPS
- Conditions
- Melasma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (actual)
- Lead sponsor
- VIST - Faculty of Applied SciencesUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 1 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Melanostop peel treatment group | Experimental | Other: Melanostop peel* Adult women aged between 20-50 years old. * Melasma on the face * Fitzpatrick phototypes I-IV * Presenting facial melasma * In good health condition |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adult women aged between 20-50 years old.
- Melasma on the face
- Fitzpatrick phototypes I-IV
- Presenting facial melasma
- In good health condition
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melanostop peelMelanostop 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 | Other | Melanostop peel treatment group |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katja Žmitek, PhD study chair
Head of Reasearch Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Melanostop peel in people with Melasma, run by VIST - Faculty of Applied Sciences at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Melasma Area and Severity Index (mMASI) (time frame: week 1, week 7, week 11). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2023; AzTrials last refreshed its copy on 8 Nov 2026.