A Phase 1 interventional study of SPF 30 sunscreen plus pharmaceutical formulation without green banana peel extract and SPF 30 sunscreen and pharmaceutical formulation containing green banana peel extract in Melasma, sponsored by Universidade do Vale do Sapucai. Completed at 1 site in Brazil. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-09-02.
Sponsored by Universidade do Vale do Sapucai · Phase 1, Interventional, and Treatment
Among 10 studies in Melanosis with a site in Brazil — 4 open to participants now, 5 under way, none of them phase 3. Melanosis · Brazil.
Among the 10 studies in Melanosis with a site in Brazil, this one is the 7th largest by enrollment, is the only one that started in 2021, is the only one in phase 1, and was the 3rd registered.
170 studies on the registry are indexed under Melanosis; 46 are open to participants now.
Browse Melanosis studies →4 of the 10 studies in Melanosis with a site in Brazil are open now. Recruiting first, the newest first:
Brainfarma Industria Química e Farmacêutica S/A · Sites in Brazil
Kenvue Brands LLC · Sites in Brazil
Cosmetique Active International · Sites in Brazil
Cosmetique Active International · Sites in Brazil
A study can be open while its sites in Brazil have not opened yet or have stopped. Only those recruiting at a site in Brazil →
Of the 19 Melanosis studies recruiting now, 8 (42%) set no upper age limit and 11 (58%) stop at 75 or younger; 1 take children under 18; 13 take healthy volunteers.
This study: 18 Years to 60 Years · female · no healthy volunteers.
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10 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 1 started in 2021.
This study's enrollment of 74 is above the median of 40 across 157 interventional studies indexed under Melanosis.
Median enrollment 110 across the 10 interventional studies. Of the 4 that completed or were terminated, 0 (0%) have results posted.
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7 of 10 have an industry lead sponsor. The 8 most frequent:
Universidade do Vale do Sapucai is the lead sponsor of 28 studies on the registry; none are open to participants now.
Universidade do Vale do Sapucai has 1 study filed under Melanosis — fewer than ten, so there is no comparison to draw.
1 of the studies in Melanosis with a site in Brazil that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07769268Brainfarma Industria Química e Farmacêutica S/AEfficacy Evaluation of a Cosmetic Product for Facial Hyperpigmentation | 2027-01-21 |
Among the 10 studies in Melanosis with a site in Brazil, from their registry updates:
Nothing recorded among them since 2026-09-25.
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To develop and evaluate a pharmaceutical formula based on green banana peel extract for the treatment of melasma.
Objective: to develop and evaluate a pharmaceutical formula based on green banana peel extract for the treatment of melasma. Methods: it will be a clinical, interventional, longitudinal study, random sampling, Sample will have 60 patients divided into two groups. In the Control Group, SPF 30 sunscreen plus pharmaceutical formulation without green banana peel extract will be used, and in the Study Group, in addition to SPF 30 sunscreen, pharmaceutical formulation containing green banana peel extract will be used. Patients will undergo treatment for 90 days, evaluated every 30 days through clinical evaluation and MELASQol.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Control Group will use SPF 30 sunscreen plus pharmaceutical formulation without green banana peel extract
Biological: SPF 30 sunscreen plus pharmaceutical formulation without green banana peel extract
In Study Group, in addition to the SPF 30 sunscreen, a pharmaceutical formulation containing the extract of the green banana peel will be used.
Biological: SPF 30 sunscreen and pharmaceutical formulation containing green banana peel extract
Control Group will use SPF 30 sunscreen plus pharmaceutical formulation without green banana peel extract
Study Group In addition to the SPF 30 sunscreen, a pharmaceutical formulation containing green banana peel extract will be used.
Clinical analysis of Melasma
Analysis of the skin affected by Melasma will be performed with Melasma Area Severity Index (MASI), the most commonly used outcome measure for melasma.
Time frame: 3 months
Quality of life analysis
Analysis of the quality of life of Melasma patients during the study will be performed using the MELASQol Instrument. It is a useful tool in assessing quality of life in patients with melasma.
Time frame: 3 months
Ran from Jun 2021 to primary completion in Jul 2021, 1 month.
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This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Universidade do Vale do Sapucai