MelasmaNCT07296549
Expert Consensus on the Clinical Management of Melasma: A Delphi Method Study
An observational study of Melasma and Melasma (Facial Melasma), run by Venus Research Center at 1 site in Egypt.
Trial summary
This study aims to gather expert opinions on the best ways to treat and manage melasma, a common skin condition characterized by dark patches on the face. Using a method called the Delphi Method, a group of dermatologists and other specialists will participate in several rounds of surveys to share their insights and… Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Melasma, Melasma (Facial Melasma)
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2026to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Target population:A purposive sample of experienced clinical dermatologists who actively manage melasma. The panel will include clinicians with diverse practice settings and geographic representation relevant to the study scope.Panel size and rationale:Target enrolment: 20-35 experts.Rationale: this size balances breadth of opinion and feasibility for iterative Delphi rounds; it is large enough to capture diverse viewpoints yet small enough to allow meaningful, anonymized feedback and analysis.Minimum required for analysis: 15 panelists
Who may be able to join
- Board-certified or equivalent dermatologist,
- Minimum of 5 years of post-certification clinical experience in the management of MELASMA,
- Willingness to participate in all Delphi rounds.
Who cannot join
- Inability or unwillingness to complete Delphi rounds.
- Lack of clinical experience with MELASMA
- Industry representatives without direct clinical practice
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This study aims to gather expert opinions on the best ways to treat and manage melasma, a common skin condition characterized by dark patches on the face. Using a method called the Delphi Method, a group of dermatologists and other specialists will participate in several rounds of surveys to share their insights and reach a consensus on the most effective treatments and management strategies. The goal is to create a set of evidence-based guidelines that can help doctors provide more consistent, effective care for patients with melasma. The study will ensure that all experts' opinions are anonymous, and the results will be shared to improve treatment practices worldwide.
Read the detailed description
This study is designed to establish expert consensus on the management and treatment of melasma through a Delphi Method approach. The Delphi Method is a structured, iterative process where a panel of specialists-primarily dermatologists and other healthcare professionals experienced in treating melasma-will be asked to respond to a series of surveys. These surveys will allow experts to share their opinions on the most effective treatments, diagnostic criteria, and management strategies for melasma.
The study will be conducted in multiple rounds:
Round 1: Experts will provide open-ended feedback on their experiences and perspectives on melasma treatment.
Round 2: Based on the responses from Round 1, a refined set of questions will be circulated to clarify or expand on the issues raised.
Round 3: A final round will help refine and solidify the consensus on treatment approaches and care protocols.
The experts' feedback will be anonymized to ensure unbiased responses, and each round will be followed by analysis to identify areas of agreement and disagreement. The goal is to achieve a high level of consensus (usually around 70%) on key treatment recommendations and best practices for managing melasma.
This process will result in evidence-based guidelines for melasma treatment that healthcare providers can use to standardize care and improve patient outcomes. These guidelines will help address the variability in treatment practices and ensure that patients receive the most effective and up-to-date care based on expert consensus.
- Conditions
- Melasma, Melasma (Facial Melasma)
- Keywords
- Melasma, consensus, expert panel, delphi method
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Expert Panel | A cohort of dermatology and aesthetic medicine experts participating in a Modified Delphi process to develop consensus recommendations on the management of melasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consensus on Diagnostic & therapeutic Criteria for Melasma
Establishment of expert consensus on core domains of melasma diagnosis and management measured by the proportion of statements reaching predefined consensus agreement after completion of delphi rounds
Measured: 6-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start1 Jun 2026 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion30 Dec 2026 (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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Venus Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07296549
- Sponsor's protocol ID
- Melasma Consensus
- Status last verified
- Dec 2025
- First submitted
- 8 Dec 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Delphi studies do not collect patient data, medical records, biological samples, or identifiable clinical information. Experts only give opinions, not "IPD." Their responses are anonymized, and sharing identifiable expert-level responses is not required and often discouraged
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expert Consensus on the Clinical Management of Melasma: A Delphi Method Study
- ClinicalTrials.gov ID
- NCT07296549
- Acronym / sponsor ID
- Melasma Consensus
- Conditions
- Melasma, Melasma (Facial Melasma)
- Keywords
- Melasma, consensus, expert panel, delphi method
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Venus Research CenterUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 22 Dec 2025 (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.
This study aims to gather expert opinions on the best ways to treat and manage melasma, a common skin condition characterized by dark patches on the face. Using a method called the Delphi Method, a group of dermatologists and other specialists will participate in several rounds of surveys to share their insights and reach a consensus on the most effective treatments and management strategies. The goal is to create a set of evidence-based guidelines that can help doctors provide more consistent, effective care for patients with melasma. The study will ensure that all experts' opinions are anonymous, and the results will be shared to improve treatment practices worldwide.
Detailed description
This study is designed to establish expert consensus on the management and treatment of melasma through a Delphi Method approach. The Delphi Method is a structured, iterative process where a panel of specialists-primarily dermatologists and other healthcare professionals experienced in treating melasma-will be asked to respond to a series of surveys. These surveys will allow experts to share their opinions on the most effective treatments, diagnostic criteria, and management strategies for melasma.
The study will be conducted in multiple rounds:
Round 1: Experts will provide open-ended feedback on their experiences and perspectives on melasma treatment.
Round 2: Based on the responses from Round 1, a refined set of questions will be circulated to clarify or expand on the issues raised.
Round 3: A final round will help refine and solidify the consensus on treatment approaches and care protocols.
The experts' feedback will be anonymized to ensure unbiased responses, and each round will be followed by analysis to identify areas of agreement and disagreement. The goal is to achieve a high level of consensus (usually around 70%) on key treatment recommendations and best practices for managing melasma.
This process will result in evidence-based guidelines for melasma treatment that healthcare providers can use to standardize care and improve patient outcomes. These guidelines will help address the variability in treatment practices and ensure that patients receive the most effective and up-to-date care based on expert consensus.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Expert Panel | – | –A cohort of dermatology and aesthetic medicine experts participating in a Modified Delphi process to develop consensus recommendations on the management of melasma |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Target population:A purposive sample of experienced clinical dermatologists who actively manage melasma. The panel will include clinicians with diverse practice settings and geographic representation relevant to the study scope.Panel size and rationale:Target enrolment: 20-35 experts.Rationale: this size balances breadth of opinion and feasibility for iterative Delphi rounds; it is large enough to capture diverse viewpoints yet small enough to allow meaningful, anonymized feedback and analysis.Minimum required for analysis: 15 panelists
Key inclusion criteria (3 listed)
- Board-certified or equivalent dermatologist,
- Minimum of 5 years of post-certification clinical experience in the management of MELASMA,
- Willingness to participate in all Delphi rounds.
Key exclusion criteria (3 listed)
- Inability or unwillingness to complete Delphi rounds.
- Lack of clinical experience with MELASMA
- Industry representatives without direct clinical practice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Consensus on Diagnostic & therapeutic Criteria for Melasma
Time frame: 6-12 weeks
Establishment of expert consensus on core domains of melasma diagnosis and management measured by the proportion of statements reaching predefined consensus agreement after completion of delphi rounds
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Individual participant dataSharing planned: No. Delphi studies do not collect patient data, medical records, biological samples, or identifiable clinical information. Experts only give opinions, not "IPD." Their responses are anonymized, and sharing identifiable expert-level responses is not required and often discouraged
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melasma and Melasma (Facial Melasma), run by Venus Research Center at 1 site in Egypt.
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: enrolling by invitation, as of the sponsor's last update on 29 Dec 2025. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
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?
Consensus on Diagnostic & therapeutic Criteria for Melasma (time frame: 6-12 weeks). 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 29 Dec 2025.