MelasmaNCT06278948
Efficacy and Tolerability of Test Product Versus Cysteamine 5% in Treatment of Facial Epidermal Melasma
A study testing Group TP and Group CYS in people with Melasma, run by Cosmetique Active International at 1 site in India.
Trial summary
This interventional, randomized, investigator blinded, controlled study conducted in one centre consists in a 4-month evaluation period within the same season avoiding sunny season on 140 subjects with facial epidermal melasma. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Melasma
- What is being tested?
- Group TP and Group CYS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteIndia
- Study dates
- 6 Oct 2023to Jun 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Facial epidermal melasma (exclude mixed and dermal melasma)
- Subjects free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the face
Who cannot join
- Subjects with any other signs of significant irritation or skin disease
- Subjects using oral contraceptive pills or hormonal implants as birth control measures during the study
- Subjects who had a skin lightening procedure in the past 8 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Investigator Blinded Comparative Study of the Efficacy and Tolerability of Test Product Versus Cysteamine 5% in the Treatment of Facial Epidermal Melasma Over 4 Months
This interventional, randomized, investigator blinded, controlled study conducted in one centre consists in a 4-month evaluation period within the same season avoiding sunny season on 140 subjects with facial epidermal melasma.
Read the detailed description
Melasma is a very common pigmentation disorder which significantly alters quality of life as per its high visibility on the face. The objective is to compare the efficacy and tolerability of the new depigmenting formulation that addresses the different targets of hyperpigmentation and includes an inhibitor of melanin production with a breakthrough innovative mechanism of action versus Cysteamine 5% in the acute management of melasma over 4 months.
Statistics:
Sample size calculation: 120 patients (60 per group) are necessary to reach the non-inferiority objective of the Test Product versus Cysteamine 5% on the modified Melasma Area and Severity Index (mMASI) change from Baseline at Month 4. To allow a rate of subjects excluded from analysis (drop out, lost to follow-up, major deviation) at Month 4, 140 subjects in total (70 per group) are enrolled.
Statistical analysis: Continuous data collected at each visit will be summarized using common statistical measures such as the count of values, mean, standard deviation, median minimum and maximum. For categorical data, summaries will be provided in terms of frequency counts (n) and percentages (%).
- Conditions
- Melasma
- Being tested
- Group TP, Group CYS
- Keywords
- facial epidermal melasma, MASI, Cysteamine 5%
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group TPOther
Also called Test Product
Application full face, twice daily, in the morning and at bedtime for 4 months
Group CYSDrug
Also called Cysteamine 5%
Application short contact, of thin layer once daily at bedtime for 4 months
| Study group | Role | What they receive |
|---|---|---|
| Group TP: Test Product | Experimental | Subjects (aged 20-50 years) with mild to severe facial epidermal melasma for more than 1 year Receives: Other: Group TP |
| Group CYS: Cysteamine 5% | Active comparator | Subjects (aged 20-50 years) with mild to severe facial epidermal melasma for more than 1 year Receives: Drug: Group CYS |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in mMASI scoring
the mMASI is calculated using 3 components: four regions of the face (forehead, right malar, left malar and chin); area of involvement for each region (using a scale from 0 to 6): darkness compared to the surrounding normal skin for each area (evaluated using a scale from 0 to 4).
Measured: from baseline to Day112
change in Investigator's Global Assessment (IGA)
The investigator evaluates the severity of melasma using a 4-point scale (from 0 (cleared, almost cleared) to 3 (severe (markedly darker than the surrounding normal skin)).
Measured: from baseline to Day112
Secondary outcomes (1)
change in Subject Global Assessment of Improvement (SGAI)
The subject evaluates the change on a 6-point scale from -1 (worsened) to 4 (totally cleared).
Measured: from Day28 to Day112
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start6 Oct 2023
- Primary completionJun 2024 (estimated)
- Study completionJun 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cosmetique Active International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mukta Sachdev, Principal investigator, MS Clinical Research Pvt. Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06278948
- Sponsor's protocol ID
- LRP23023-depigmenting cream
- Status last verified
- Feb 2024
- First submitted
- 19 Feb 2024
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Investigator Blinded Comparative Study of the Efficacy and Tolerability of Test Product Versus Cysteamine 5% in the Treatment of Facial Epidermal Melasma Over 4 Months
- ClinicalTrials.gov ID
- NCT06278948
- Acronym / sponsor ID
- LRP23023-depigmenting cream
- Conditions
- Melasma
- Keywords
- facial epidermal melasma, MASI, Cysteamine 5%
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Cosmetique Active InternationalIndustry (pharma, biotech, devices)
- Study start
- 6 Oct 2023 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 26 Feb 2024 (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 interventional, randomized, investigator blinded, controlled study conducted in one centre consists in a 4-month evaluation period within the same season avoiding sunny season on 140 subjects with facial epidermal melasma.
Detailed description
Melasma is a very common pigmentation disorder which significantly alters quality of life as per its high visibility on the face. The objective is to compare the efficacy and tolerability of the new depigmenting formulation that addresses the different targets of hyperpigmentation and includes an inhibitor of melanin production with a breakthrough innovative mechanism of action versus Cysteamine 5% in the acute management of melasma over 4 months.
Statistics:
Sample size calculation: 120 patients (60 per group) are necessary to reach the non-inferiority objective of the Test Product versus Cysteamine 5% on the modified Melasma Area and Severity Index (mMASI) change from Baseline at Month 4. To allow a rate of subjects excluded from analysis (drop out, lost to follow-up, major deviation) at Month 4, 140 subjects in total (70 per group) are enrolled.
Statistical analysis: Continuous data collected at each visit will be summarized using common statistical measures such as the count of values, mean, standard deviation, median minimum and maximum. For categorical data, summaries will be provided in terms of frequency counts (n) and percentages (%).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group TP: Test Product | Experimental | Other: Group TPSubjects (aged 20-50 years) with mild to severe facial epidermal melasma for more than 1 year |
| Group CYS: Cysteamine 5% | Active comparator | Drug: Group CYSSubjects (aged 20-50 years) with mild to severe facial epidermal melasma for more than 1 year |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Facial epidermal melasma (exclude mixed and dermal melasma)
- Subjects free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the face
Key exclusion criteria (3 listed)
- Subjects with any other signs of significant irritation or skin disease
- Subjects using oral contraceptive pills or hormonal implants as birth control measures during the study
- Subjects who had a skin lightening procedure in the past 8 weeks
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 |
|---|---|---|
| Group TPAlso: Test ProductApplication full face, twice daily, in the morning and at bedtime for 4 months | Other | Group TP: Test Product |
| Group CYSAlso: Cysteamine 5%Application short contact, of thin layer once daily at bedtime for 4 months | Drug | Group CYS: Cysteamine 5% |
Primary outcome
change in mMASI scoring
Time frame: from baseline to Day112
the mMASI is calculated using 3 components: four regions of the face (forehead, right malar, left malar and chin); area of involvement for each region (using a scale from 0 to 6): darkness compared to the surrounding normal skin for each area (evaluated using a scale from 0 to 4).
change in Investigator's Global Assessment (IGA)
Time frame: from baseline to Day112
The investigator evaluates the severity of melasma using a 4-point scale (from 0 (cleared, almost cleared) to 3 (severe (markedly darker than the surrounding normal skin)).
1 secondary outcome
change in Subject Global Assessment of Improvement (SGAI)
Time frame: from Day28 to Day112
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
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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.
Mukta Sachdev principal investigator
MS Clinical Research Pvt. Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group TP and Group CYS in people with Melasma, run by Cosmetique Active International at 1 site in India.
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 2 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: status not confirmed, as of the sponsor's last update on 26 Feb 2024. 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 India. 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?
Contact Mukta Sachdev (+91 8041125934, mukta.sachdev@msclinical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in mMASI scoring (time frame: from baseline to Day112). 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 26 Feb 2024.