MelasmaPhase 2NCT02730819
Topical Composition Therapy (2013-MCN-333) for the Treatment of Melasma
A Phase 2 study testing Illuminate Cream in people with Melasma, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this research study is to gather information on the effectiveness and tolerability of a novel composition of existing U.S. Food and Drug Administration (FDA) approved topical medications for the treatment of moderate to severe melasma. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Melasma
- What is being tested?
- Illuminate Cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2016to 30 Dec 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed subject consent will be obtained from those patients meeting the following inclusion criteria:
- Male and female patients 18 to 65 years age
- Moderate to severe melasma, as measured by the Melasma Area Severity Index score greater than or equal to 16
- No prior use of topical skin-lightening agents for 1 month prior to study entry
- Good general health as confirmed by medical history
- Female patients of child-bearing potential with a negative urine pregnancy test who agree to use effective methods of birth control or remain abstinent during treatment. Participants must use birth control for the entire study and for at least 1 week after the last application of the study formulation. Acceptable methods of birth control include ongoing hormonal contraception methods, (such as birth control pills, patches, injections, vaginal ring, or implants), barrier methods (such as a condom or diaphragm used with a spermicide), intrauterine devices, tubal ligation, or abstinence
- Patients who are willing and capable of cooperating to the extent and degree required by the protocol; and
- Patients who read and sign an approved informed consent for this study
Who cannot join
- Vulnerable study population
- Exposure to topical skin-lightening agents within 1 month of study entry, including:
- Topical corticosteroids
- Topical bleaching products
- Topical retinoids
- Use of systemic preparations within 1 month of study entry, including:
Show all 15Show fewer
- Systemic corticosteroids
- Systemic cyclosporine, interferon
- Systemic acitretin, etretinate, isotretinoin
- Systemic methotrexate
- Systemic photoallergic, phototoxic and/or photosensitizing drugs
- UV light therapy and sunbathing
- Inability to communicate or cooperate with the Principal Investigator and/or Investigators due to language problems, poor mental development or impaired cerebral function
- Pregnant or nursing women
- Women planning a pregnancy within the study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label Pilot Study Evaluating the Effectiveness and Tolerability of a Topical Composition Therapy (2013-MCN-333) for the Treatment of Melasma
The purpose of this research study is to gather information on the effectiveness and tolerability of a novel composition of existing U.S. Food and Drug Administration (FDA) approved topical medications for the treatment of moderate to severe melasma.
Read the detailed description
Subjects with moderate to severe melasma will apply 0.5 grams (pea-sized) amount of Illuminate Cream topically to affected areas for 20 weeks. The change in Melasma Area and Severity Index (MASI) score will be evaluated a baseline and Weeks 4, 12, and 20.
The MASI score is a validated test, calculated by subjective assessment of 3 factors: Area (A) of involvement, Darkness (D), and Homogeneity (H), with the forehead, right malar region, left malar region, and chin, corresponding to 30%, 30%, 30% and 10% of the total face, respectively. The area of involvement in each of these 4 areas is given a numeric value of 0 to 6 (0 = no involvement; 1 = <10%; 2 = 10%-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; and 6 = 90-100%).
Darkness and homogeneity are rated on a scale from 0 to 4 (0 = absent; 1 = slight; 2 = mild; 3 = marked; and 4 = maximum). The score is calculated by adding the sum of the severity ratings for darkness and homogeneity, multiplied by the value of the area of involvement, for each of the 4 facial areas.
- Conditions
- Melasma
- Being tested
- Illuminate Cream
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Illuminate CreamDrug
Also called 2013-MCN-333
Topical compound applied daily
| Study group | Role | What they receive |
|---|---|---|
| Illuminate Cream | Experimental | Illuminate Cream is a skin-lightening formulation containing multiple drugs, including a retinoid, calcineurin inhibitor, anti-tyrosinase agent and sunscreen microfine zinc oxide. Approximately 0.5 grams to be applied topically to affected areas of skin once per day for 20 weeks. Receives: Drug: Illuminate Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Melasma Area and Severity Index (MASI) Score
Severity of melasma in each of the four regions (forehead, right malar region, left malar region and chin) is assessed on % of the total area involved (A), darkness (D), and homogeneity (H).
Scoring for % area involved: 0=none; 1=<10%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; and 6=90-100%. Darkness scoring (hyperpigmentation): 0=normal skin; 1=barely visible; 2=mild; 3=moderate; 4=severe. Homogeneity scoring: 0=normal skin color; 1=specks of involvement; 2=small patchy areas of involvement <1.5 cm diameter; 3=patches of involvement >2 cm diameter; 4=uniform skin involvement without any clear areas).
To calculate the MASI score, the sum of the severity grade for darkness (D) and homogeneity (H) is multiplied by the numerical value of the areas (A) involved and by the percentages of the four facial areas (10-30%). Total MASI score: Forehead 0.3 (D+H)A + right malar 0.3 (D+H)A + left malar 0.3 (D+H)A + chin 0.1 (D+H)A. The total score can range from 0 (normal) to 48 (severe).
Measured: Baseline, 20 weeks
Secondary outcomes (2)
Change in Melasma Quality of Life Scale (MELASQOL)
The Melasma Quality of Life Scale has 10 items, with responses ranging from 0 (no response) to 7 (bothered all the time. The range of possible scores is 0-70, with a higher score indicating a worse melasma-related quality of life.
Measured: baseline, 20 weeks
Investigator Assessment of Global Improvement From Baseline
The investigator compared the extent of melasma at 20 weeks to a full-face photograph obtained in a standardized manner at baseline. It is a dynamic 7-point scale (0=completely clear to 7=worse).
Measured: baseline, 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2016 (estimated)
- Study start15 May 2016
- Primary completion30 Dec 2016
- Study completion30 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MelasmaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Sluzevich, Mayo Clinic
- Investigators
- Jason C Sluzevich, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02730819
- Sponsor's protocol ID
- 15-005615
- Status last verified
- Sep 2017
- First submitted
- 29 Mar 2016
- Last updated
- 20 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Pilot Study Evaluating the Effectiveness and Tolerability of a Topical Composition Therapy (2013-MCN-333) for the Treatment of Melasma
- ClinicalTrials.gov ID
- NCT02730819
- Acronym / sponsor ID
- 15-005615
- Conditions
- Melasma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 15 May 2016 (actual)
- Primary completion
- 30 Dec 2016 (actual)
- Study completion
- 30 Dec 2016 (actual)
- First posted
- 7 Apr 2016 (estimated)
- Results
- Posted 20 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to gather information on the effectiveness and tolerability of a novel composition of existing U.S. Food and Drug Administration (FDA) approved topical medications for the treatment of moderate to severe melasma.
Detailed description
Subjects with moderate to severe melasma will apply 0.5 grams (pea-sized) amount of Illuminate Cream topically to affected areas for 20 weeks. The change in Melasma Area and Severity Index (MASI) score will be evaluated a baseline and Weeks 4, 12, and 20.
The MASI score is a validated test, calculated by subjective assessment of 3 factors: Area (A) of involvement, Darkness (D), and Homogeneity (H), with the forehead, right malar region, left malar region, and chin, corresponding to 30%, 30%, 30% and 10% of the total face, respectively. The area of involvement in each of these 4 areas is given a numeric value of 0 to 6 (0 = no involvement; 1 = <10%; 2 = 10%-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; and 6 = 90-100%).
Darkness and homogeneity are rated on a scale from 0 to 4 (0 = absent; 1 = slight; 2 = mild; 3 = marked; and 4 = maximum). The score is calculated by adding the sum of the severity ratings for darkness and homogeneity, multiplied by the value of the area of involvement, for each of the 4 facial areas.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Illuminate Cream | Experimental | Drug: Illuminate CreamIlluminate Cream is a skin-lightening formulation containing multiple drugs, including a retinoid, calcineurin inhibitor, anti-tyrosinase agent and sunscreen microfine zinc oxide. Approximately 0.5 grams to be applied topically to affected areas of skin once per day for 20 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Informed subject consent will be obtained from those patients meeting the following inclusion criteria:
- Male and female patients 18 to 65 years age
- Moderate to severe melasma, as measured by the Melasma Area Severity Index score greater than or equal to 16
- No prior use of topical skin-lightening agents for 1 month prior to study entry
- Good general health as confirmed by medical history
Key exclusion criteria (15 listed)
- Vulnerable study population
- Exposure to topical skin-lightening agents within 1 month of study entry, including:
- Use of systemic preparations within 1 month of study entry, including:
- UV light therapy and sunbathing
- Inability to communicate or cooperate with the Principal Investigator and/or Investigators due to language problems, poor mental development or impaired cerebral function
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 |
|---|---|---|
| Illuminate CreamAlso: 2013-MCN-333Topical compound applied daily | Drug | Illuminate Cream |
Primary outcome
Change in Melasma Area and Severity Index (MASI) Score
Time frame: Baseline, 20 weeks
Severity of melasma in each of the four regions (forehead, right malar region, left malar region and chin) is assessed on % of the total area involved (A), darkness (D), and homogeneity (H). Scoring for % area involved: 0=none; 1=<10%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; and 6=90-100%. Darkness scoring (hyperpigmentation): 0=normal skin; 1=barely visible; 2=mild; 3=moderate; 4=severe. Homogeneity scoring: 0=normal skin color; 1=specks of involvement; 2=small patchy areas of involvement <1.5 cm diameter; 3=patches of involvement >2 cm diameter; 4=uniform skin involvement without any clear areas). To calculate the MASI score, the sum of the severity grade for darkness (D) and homogeneity (H) is multiplied by the numerical value of the areas (A) involved and by the percentages of the four facial areas (10-30%). Total MASI score: Forehead 0.3 (D+H)A + right malar 0.3 (D+H)A + left malar 0.3 (D+H)A + chin 0.1 (D+H)A. The total score can range from 0 (normal) to 48 (severe).
2 secondary outcomes
Change in Melasma Quality of Life Scale (MELASQOL)
Time frame: baseline, 20 weeks
Investigator Assessment of Global Improvement From Baseline
Time frame: baseline, 20 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Jason C Sluzevich, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Illuminate Cream in people with Melasma, run by Mayo Clinic at 1 site in United States.
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 8 inclusion and 15 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 20 Oct 2017. 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Melasma Area and Severity Index (MASI) Score (time frame: Baseline, 20 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 20 Oct 2017.