MelasmaPhase 1NCT05031689
Green Banana Peel Extract for Melasma Treatment
A Phase 1 study testing SPF 30 sunscreen plus pharmaceutical formulation without green banana peel extract and SPF 30 sunscreen and pharmaceutical formulation containing green banana peel extract in people with Melasma, run by Universidade do Vale do Sapucai at 1 site in Brazil.
Trial summary
To develop and evaluate a pharmaceutical formula based on green banana peel extract for the treatment of melasma. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Melasma
- What is being tested?
- SPF 30 sunscreen plus pharmaceutical formulation without green banana peel extract and SPF 30 sunscreen and pharmaceutical formulation containing green banana peel extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Jun 2021to 10 Aug 2021
- Phase
- Phase 1
- 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 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female patients with melasma.
- Patients aged 18 years or over and 60 years or less.
- Patients who agree to participate in the study. -
Who cannot join
- Patients who have other types of facial hyperchromia.
- Patients who give up, for any reason, to continue treatment.
- Patients who have any type of allergic reaction to the product.
Trial locations and contacts
1 site in 1 country.
About this study
To develop and evaluate a pharmaceutical formula based on green banana peel extract for the treatment of melasma.
Read the detailed description
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.
- Conditions
- Melasma
- Being tested
- SPF 30 sunscreen plus pharmaceutical formulation without green banana peel extract, SPF 30 sunscreen and pharmaceutical formulation containing green banana peel extract
- Keywords
- Melasma, banana, skin, sunscreen
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPF 30 sunscreen plus pharmaceutical formulation without green banana peel extractBiological
Control Group will use SPF 30 sunscreen plus pharmaceutical formulation without green banana peel extract
SPF 30 sunscreen and pharmaceutical formulation containing green banana peel extractBiological
Study Group In addition to the SPF 30 sunscreen, a pharmaceutical formulation containing green banana peel extract will be used.
| Study group | Role | What they receive |
|---|---|---|
| SPF 30 and Placebo | Placebo comparator | Control Group will use SPF 30 sunscreen plus pharmaceutical formulation without green banana peel extract Receives: Biological: SPF 30 sunscreen plus pharmaceutical formulation without green banana peel extract |
| SPF 30 and pharmaceutical formulation with green banana peel | Active comparator | In Study Group, in addition to the SPF 30 sunscreen, a pharmaceutical formulation containing the extract of the green banana peel will be used. Receives: Biological: SPF 30 sunscreen and pharmaceutical formulation containing green banana peel extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start30 Jun 2021
- Primary completion30 Jul 2021
- Study completion10 Aug 2021
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Vale do Sapucai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adriana Rodrigues dos Anjos Mendonça, Universidade do Vale do Sapucai
- Investigators
- Adriana R dos Anjos Mendonça, PhD, Principal investigator, Vale do Sapucaí University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05031689
- Sponsor's protocol ID
- Melasma
- Status last verified
- Aug 2021
- First submitted
- 20 Aug 2021
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Green Banana Peel Extract for Melasma Treatment
- ClinicalTrials.gov ID
- NCT05031689
- Acronym / sponsor ID
- Melasma
- Conditions
- Melasma
- Keywords
- Melasma, banana, skin, sunscreen
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Universidade do Vale do SapucaiUniversity, hospital or other
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 10 Aug 2021 (actual)
- First posted
- 2 Sep 2021 (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.
To develop and evaluate a pharmaceutical formula based on green banana peel extract for the treatment of melasma.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPF 30 and Placebo | Placebo comparator | Biological: SPF 30 sunscreen plus pharmaceutical formulation without green banana peel extractControl Group will use SPF 30 sunscreen plus pharmaceutical formulation without green banana peel extract |
| SPF 30 and pharmaceutical formulation with green banana peel | Active comparator | Biological: SPF 30 sunscreen and pharmaceutical formulation containing green banana peel extractIn Study Group, in addition to the SPF 30 sunscreen, a pharmaceutical formulation containing the extract of the green banana peel will be used. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female patients with melasma.
- Patients aged 18 years or over and 60 years or less.
- Patients who agree to participate in the study. -
Key exclusion criteria (3 listed)
- Patients who have other types of facial hyperchromia.
- Patients who give up, for any reason, to continue treatment.
- Patients who have any type of allergic reaction to the product.
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 |
|---|---|---|
| SPF 30 sunscreen plus pharmaceutical formulation without green banana peel extractControl Group will use SPF 30 sunscreen plus pharmaceutical formulation without green banana peel extract | Biological | SPF 30 and Placebo |
| SPF 30 sunscreen and pharmaceutical formulation containing green banana peel extractStudy Group In addition to the SPF 30 sunscreen, a pharmaceutical formulation containing green banana peel extract will be used. | Biological | SPF 30 and pharmaceutical formulation with green banana peel |
Primary outcome
Clinical analysis of Melasma
Time frame: 3 months
Analysis of the skin affected by Melasma will be performed with Melasma Area Severity Index (MASI), the most commonly used outcome measure for melasma.
Quality of life analysis
Time frame: 3 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
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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.
Adriana R dos Anjos Mendonça, PhD principal investigator
Vale do Sapucaí University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SPF 30 sunscreen plus pharmaceutical formulation without green banana peel extract and SPF 30 sunscreen and pharmaceutical formulation containing green banana peel extract in people with Melasma, run by Universidade do Vale do Sapucai at 1 site in Brazil.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 2 Sep 2021. 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 Brazil. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical analysis of Melasma (time frame: 3 months). The study lists 2 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 2 Sep 2021.