MelasmaNCT02977507
Split-face Study Comparing the Cosmetic Efficacy and Tolerability of Two Topical Products in Participants With Moderate Facial Melasma
A study testing Lytera 2.0, 4% Hydroquinone Topical Cream and SkinMedica Facial Cleanser in people with Melasma, run by Allergan at 1 site in United States.
Trial summary
The objective of this study is to evaluate the efficacy and tolerability of Lytera 2.0 versus 4% hydroquinone in the improvement of the appearance of moderate facial melasma. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Melasma
- What is being tested?
- Lytera 2.0, 4% Hydroquinone Topical Cream and SkinMedica Facial Cleanser
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2016to 9 Oct 2017
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female or male aged 18+ years with general good health
- Individuals with dark patches on both sides of their face
- Individuals that are willing to provide written informed consent and are able to read, speak, write, and understand English.
- Individuals willing to sign have their photographs taken during the study and are willing to sign a photography release.
- Willing to stop all facial treatments during the course of the study including botulinum toxin, injectable fillers, microdermabrasion, Intense pulsed light (IPL), peels, facials, waxing, laser treatments and tightening treatments. Threading is allowed but not facial laser hair removal.
- Willingness to cooperate follow all study requirements for the duration of the study and to report any changes in health status or medications, adverse event symptoms, or reactions immediately.
- Willingness to not begin using any new cosmetic facial make-up during the study. If you regularly use cosmetic facial make-up, you must have used the product(s) without any issues for at least 2 weeks prior to starting the study.
- Willingness to avoid sun exposure to the face as much as possible, (including tanning beds), especially from 10 AM to 2 PM. Protective clothing (i.e. hats) and the provided sunscreen should be worn prior to and during any exposure.
Who cannot join
- Individuals diagnosed with known allergies to study provided skin care products.
- Individuals who are nursing, pregnant, or planning to become pregnant during the study according to subject self-report.
- Individuals with a history of skin cancer.
- Individuals having a health condition on the face (e.g., psoriasis, rosacea, acne, eczema, seborrheic dermatitis, severe excoriations etc.).
- Individuals with a history of immunosuppression/immune deficiency disorders (including (Human immunodeficiency virus (HIV) infection or Acquired Immune Deficiency Syndrome (AIDS)) or currently using immunosuppressive medications (e.g., azathioprine, belimumab, cyclophosphamide, Enbrel, Imuran, Humira, mycophenolate mofetil, methotrexate, prednisone, Remicade, Stelara.) and/or radiation.
- Individuals with an uncontrolled disease such as asthma, diabetes, hypertension, hyperthyroidism, or hypothyroidism. Individuals having multiple health conditions may be excluded from participation even if the conditions are controlled by diet, medication, etc.
Show all 21Show fewer
- Individuals with any planned surgeries and/or invasive medical procedures during the course of the study.
- Individuals who are currently participating in any other facial usage study or have participated in any clinical trial within 4 weeks prior to inclusion into the study.
- Individuals who have observable suntan, scars, nevi, excessive hair, etc. or other dermal conditions on the face that might influence the test results in the opinion of the Investigator or designee.
- Individuals who started hormone replacement therapies (HRT) or hormones for birth control less than 3 months prior to study entry or who plan on starting, stopping, or changing doses of HRT or hormones for birth control during the study.
- Individuals who used any of the following medications or had any of the listed procedures within the listed time frame prior to the study start date:
- Retin-A®, Retin-A Micro®, Renova®, Avita®, Tazorac®, or Differin® within 3 months
- Had a light-depth chemical peel or microdermabrasion within 1 month
- Had a medium-depth chemical peel, medium-depth microdermabrasion, any systemic steroids, non-ablative laser, light and/or radio frequency or fractional laser resurfacing of the face and neck within 3 months
- Any systemic retinoid (e.g. Soriatane®, Accutane®, Roche Dermatologics) within 12 months
- Any topical or systemic antibiotics, such as minocycline, or any other known medications that can cause photosensitivity, such as hydrochlorothiazide, lasix, amiodarone, within 1 month
- Any topical tretinoin product or derivative, imiquimod, 5-fluorouracil, or diclofenac on their face within 3 months
- Prescription strength skin lightening products (e.g. 4% hydroquinone, tretinoin, alpha hydroxy acid (AHA), beta hydroxy acid (BHA) and polyhydroxy acids, 15% or 20% azelaic acid, 4-hydroxyanisole alone or in combination with tretinoin, etc.) within 3 months
- Any non-prescription cosmetic anti-wrinkle, skin lightening products, or any other product or topical or systemic medication known to affect skin aging or dyshcromia (products containing alpha/beta/poly-hydroxy acids, vitamin C, soy, Q-10, hydroquinone; systemic or licorice extract (topically), Tego® Cosmo C250, gigawhite, lemon juice extract (topically), emblica extract, etc.) within 2 weeks
- Have undergone plastic surgery, Dermabrasion (deep skin peel), a deep chemical peel or ablative laser resurfacing of the face and neck within 12 months
- Had facial treatment with a botulinum toxin base injectable (Botox), injectable fillers, or a fat transfer within 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai St. Luke's Hospital
New York, New York, 10025
About this study
Official title: Randomized, Double-blinded, Split-face Study Comparing the Cosmetic Efficacy and Tolerability of Two Topical Products in Subjects With Moderate Facial Melasma
The objective of this study is to evaluate the efficacy and tolerability of Lytera 2.0 versus 4% hydroquinone in the improvement of the appearance of moderate facial melasma.
- Conditions
- Melasma
- Being tested
- Lytera 2.0, 4% Hydroquinone Topical Cream, SkinMedica Facial Cleanser, SkinMedica Rejuvenative Moisturizer, SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lytera 2.0Other
Lytera 2.0 applied to the affected areas twice a day, in the morning and evening, every day for 12 weeks.
4% Hydroquinone Topical CreamDrug
4% Hydroquinone Topical Cream applied to the affected areas twice a day, in the morning and evening, every day for 12 weeks.
SkinMedica Facial CleanserOther
SkinMedica facial cleanser applied to the face as directed.
SkinMedica Rejuvenative MoisturizerOther
SkinMedica rejuvenative moisturizer applied to the face as directed.
SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 SunscreenOther
SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 sunscreen applied to the face as directed.
| Study group | Role | What they receive |
|---|---|---|
| Lytera 2.0 | Experimental | Lytera 2.0 applied to the affected areas (dark patches) on one side of the face twice a day, in the morning and evening, every day for 12 weeks. SkinMedica Facial Cleanser, SkinMedica Rejuvenative Moisturizer, and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen were also applied to the face as directed. Receives: Other: Lytera 2.0; Other: SkinMedica Facial Cleanser; Other: SkinMedica Rejuvenative Moisturizer; Other: SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen |
| 4% Hydroquinone Topical Cream | Active comparator | 4% hydroquinone topical prescription cream applied to the affected areas (dark patches) on the other side of the face twice a day, in the morning and evening, every day for 12 weeks. SkinMedica Facial Cleanser, SkinMedica Rejuvenative Moisturizer, and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen were also applied to the face as directed. Receives: Drug: 4% Hydroquinone Topical Cream; Other: SkinMedica Facial Cleanser; Other: SkinMedica Rejuvenative Moisturizer; Other: SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Melasma Severity Rating Scale Score to Week 12
The investigator assessed the participant's facial skin for the severity of symmetrical facial melasma on the left and the right side of the face using the Melasma Severity Rating Scale. The score ranges from 0 to 3, where 0=Cleared: color of melasma lesions approximately equivalent to surrounding normal skin or with minimal residual hyperpigmentation, 1=Mild: color slightly darker than the surrounding normal skin, 2=Moderate: color moderately darker than the surrounding normal skin and 3=Severe: color markedly darker than the surrounding normal skin. A negative change from Baseline indicates improvement.
Measured: Baseline (Day 1) to Week 12
Change From Baseline in Overall Hyperpigmentation Scale Score to Week 12
The investigator assessed the participant's left and right facial sides for overall hyperpigmentation using the Overall Hyperpigmentation ten-point scale ranging from 0 to 9, where Score 0=None, skin is normal in color with no evidence of hyperpigmentation; Score 1, 2 or 3=Mild, several brown spots with increased pigmentation, they are small in size and slightly darker than surrounding skin; Score 4, 5 or 6=Moderate, many brown spots with increased pigmentation, they are medium in size and much darker than surrounding skin; Score of 7, 8 or 9=Severe, many large brown spots with increased pigmentation, they are large in size and markedly darker than surrounding skin. A negative change from Baseline indicates improvement.
Measured: Baseline (Day 1) to Week 12
Change From Baseline in Melasma Area and Severity Index (MASI) Score to Week 12
The investigator assigned a grade for the left and right facial sides for each of the following: A=Total Area Involved (0=No involvement to 6=90 to 100% involvement); D=Darkness of Pigment (0=Normal skin color to 4=Severe hyperpigmentation); and H=Homogeneity (0=Normal skin color without evidence of hyperpigmentation to 4=Uniform skin involvement without any clear areas). Total Half-Face MASI score was calculated as: Half Forehead 0.15(D+H)A + One Malar Side 0.3 (D+H)A + Half Chin 0.05(D+H)A. A negative change from Baseline indicates improvement.
Measured: Baseline (Day1) to Week 12
Secondary outcomes (6)
Number of Participants by Responses for Self-Assessment Questionnaire: Overall Improvement in Skin Condition
Using the Subject Self-Assessment Questionnaire: Overall Improvement, the participant selected a response that best represented their feelings on the overall improvement in their skin condition compared to the beginning of the study. Responses were categorized as: 0=No change or a worsening in my skin condition (dark areas of color on skin), 1=I see a slight improvement in my skin condition (approximately 25% overall improvement), 2=I see a moderate improvement in my skin condition (approximately 50% overall improvement), 3=I see a marked improvement in my skin condition (approximately 75% overall improvement), 4=I see a complete clearing of my skin condition (approximately 95% or better overall improvement).
Measured: Baseline (Day 1) to Weeks 4, 8 and 12
Number of Participants by Responses for Self-Assessment Questionnaire: Overall Satisfaction With the Test Product
Using the Subject Self-Assessment Questionnaire: Satisfaction with Treatment, the participant selected a response that best represented their overall satisfaction with the test product. Responses were categorized as: 1=Excellent (very satisfied), 2=Good (moderately satisfied), 3=Fair (slightly satisfied) and 4=Poor (not satisfied at all).
Measured: Weeks 4, 8 and 12
Number of Participants by Responses for Self-Assessment Questionnaire: Test Product Preference
Using the Subject Self-Assessment Questionnaire: Facial Side Preference, the participant selected based on their experience, the Test Product they preferred to use.
Measured: Weeks 4, 8 and 12
Change From Baseline in Melasma Quality of Life (MELASQOL) Scale Total Score to Week 12
The Melasma Quality of Life Scale assesses the effect melasma has on the quality of life of sufferers on a scale of 1 (not bothered at all) to 7 (bothered all of the time), rating the following questions: 1.The appearance of your skin condition 2.Frustration about your skin condition. 3.Embarrassment about your skin condition. 4.Feeling depressed about your skin condition. 5.The effects of your skin condition on your interactions with other people. 6.The effects of your skin condition on your desire to be with people. 7.Your skin condition making it hard to show affection. 8.Skin discoloration making you feel unattractive to others. 9.Skin discoloration making you feel less vital or productive. 10.Skin discoloration affecting your sense of freedom. The MELASQOL is scored from 7 to 70, with a higher score indicating worse melasma-related health-related quality of life. A negative change from Baseline indicates improvement.
Measured: Baseline (Day 1) to Week 12
Investigator's Global Improvement Assessment for Overall Hyperpigmentation Score to Week 12
Investigator's global improvement assessment score was used for assessment of overall hyperpigmentation on the left and right facial sides. The score ranged from 0 to 4 where, 0=No change or worsening, 1=Mild improvement (approximately 25% overall improvement), 2=Moderate improvement (approximately 50% overall improvement), 3=Marked improvement (approximately 75% overall improvement), 4=Complete clearing/Dramatic improvement (approximately 95% plus overall improvement). The mean score for overall hyperpigmentation was reported.
Measured: Week 12
Change From Baseline in Mexameter Measurement of Target Hyperpigmentation Lesion to Week 12
Two target hyperpigmented lesions were selected from the left and the right malar facial areas and were measured by the mexameter, an instrument that measures melanin content. One target "normal" measurement was also taken from an unaffected skin area on the face representing normal skin. The values from the target hyperpigmented lesions were compared to the normal lesion value. The range of melamin index and erythema is 0 to 999 Arbitrary Units (AU). A negative change from Baseline indicates improvement.
Measured: Baseline (Day 1) to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2016 (estimated)
- Study start13 Dec 2016
- Primary completion9 Oct 2017
- Study completion9 Oct 2017
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.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elizabeth Makino, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02977507
- Sponsor's protocol ID
- SKM16-LYT-MEL
- Status last verified
- Nov 2018
- First submitted
- 28 Nov 2016
- Last updated
- 19 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blinded, Split-face Study Comparing the Cosmetic Efficacy and Tolerability of Two Topical Products in Subjects With Moderate Facial Melasma
- ClinicalTrials.gov ID
- NCT02977507
- Acronym / sponsor ID
- SKM16-LYT-MEL
- Conditions
- Melasma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 13 Dec 2016 (actual)
- Primary completion
- 9 Oct 2017 (actual)
- Study completion
- 9 Oct 2017 (actual)
- First posted
- 30 Nov 2016 (estimated)
- Results
- Posted 7 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the efficacy and tolerability of Lytera 2.0 versus 4% hydroquinone in the improvement of the appearance of moderate facial melasma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lytera 2.0 | Experimental | Other: Lytera 2.0, Other: SkinMedica Facial Cleanser, Other: SkinMedica Rejuvenative Moisturizer, Other: SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 SunscreenLytera 2.0 applied to the affected areas (dark patches) on one side of the face twice a day, in the morning and evening, every day for 12 weeks. SkinMedica Facial Cleanser, SkinMedica Rejuvenative Moisturizer, and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen were also applied to the face as directed. |
| 4% Hydroquinone Topical Cream | Active comparator | Drug: 4% Hydroquinone Topical Cream, Other: SkinMedica Facial Cleanser, Other: SkinMedica Rejuvenative Moisturizer, Other: SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen4% hydroquinone topical prescription cream applied to the affected areas (dark patches) on the other side of the face twice a day, in the morning and evening, every day for 12 weeks. SkinMedica Facial Cleanser, SkinMedica Rejuvenative Moisturizer, and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen were also applied to the face as directed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female or male aged 18+ years with general good health
- Individuals with dark patches on both sides of their face
- Individuals that are willing to provide written informed consent and are able to read, speak, write, and understand English.
- Individuals willing to sign have their photographs taken during the study and are willing to sign a photography release.
- Willing to stop all facial treatments during the course of the study including botulinum toxin, injectable fillers, microdermabrasion, Intense pulsed light (IPL), peels, facials, waxing, laser treatments and tightening treatments. Threading is allowed but not facial laser hair removal.
Key exclusion criteria (21 listed)
- Individuals diagnosed with known allergies to study provided skin care products.
- Individuals who are nursing, pregnant, or planning to become pregnant during the study according to subject self-report.
- Individuals with a history of skin cancer.
- Individuals having a health condition on the face (e.g., psoriasis, rosacea, acne, eczema, seborrheic dermatitis, severe excoriations etc.).
- Individuals with a history of immunosuppression/immune deficiency disorders (including (Human immunodeficiency virus (HIV) infection or Acquired Immune Deficiency Syndrome (AIDS)) or currently using immunosuppressive medications (e.g., azathioprine, belimumab, cyclophosphamide, Enbrel, Imuran, Humira, mycophenolate mofetil, methotrexate, prednisone, Remicade, Stelara.) and/or radiation.
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 |
|---|---|---|
| Lytera 2.0Lytera 2.0 applied to the affected areas twice a day, in the morning and evening, every day for 12 weeks. | Other | Lytera 2.0 |
| 4% Hydroquinone Topical Cream4% Hydroquinone Topical Cream applied to the affected areas twice a day, in the morning and evening, every day for 12 weeks. | Drug | 4% Hydroquinone Topical Cream |
| SkinMedica Facial CleanserSkinMedica facial cleanser applied to the face as directed. | Other | 4% Hydroquinone Topical Cream, Lytera 2.0 |
| SkinMedica Rejuvenative MoisturizerSkinMedica rejuvenative moisturizer applied to the face as directed. | Other | 4% Hydroquinone Topical Cream, Lytera 2.0 |
| SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 SunscreenSkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 sunscreen applied to the face as directed. | Other | 4% Hydroquinone Topical Cream, Lytera 2.0 |
Primary outcome
Change From Baseline in Melasma Severity Rating Scale Score to Week 12
Time frame: Baseline (Day 1) to Week 12
The investigator assessed the participant's facial skin for the severity of symmetrical facial melasma on the left and the right side of the face using the Melasma Severity Rating Scale. The score ranges from 0 to 3, where 0=Cleared: color of melasma lesions approximately equivalent to surrounding normal skin or with minimal residual hyperpigmentation, 1=Mild: color slightly darker than the surrounding normal skin, 2=Moderate: color moderately darker than the surrounding normal skin and 3=Severe: color markedly darker than the surrounding normal skin. A negative change from Baseline indicates improvement.
Change From Baseline in Overall Hyperpigmentation Scale Score to Week 12
Time frame: Baseline (Day 1) to Week 12
The investigator assessed the participant's left and right facial sides for overall hyperpigmentation using the Overall Hyperpigmentation ten-point scale ranging from 0 to 9, where Score 0=None, skin is normal in color with no evidence of hyperpigmentation; Score 1, 2 or 3=Mild, several brown spots with increased pigmentation, they are small in size and slightly darker than surrounding skin; Score 4, 5 or 6=Moderate, many brown spots with increased pigmentation, they are medium in size and much darker than surrounding skin; Score of 7, 8 or 9=Severe, many large brown spots with increased pigmentation, they are large in size and markedly darker than surrounding skin. A negative change from Baseline indicates improvement.
Change From Baseline in Melasma Area and Severity Index (MASI) Score to Week 12
Time frame: Baseline (Day1) to Week 12
The investigator assigned a grade for the left and right facial sides for each of the following: A=Total Area Involved (0=No involvement to 6=90 to 100% involvement); D=Darkness of Pigment (0=Normal skin color to 4=Severe hyperpigmentation); and H=Homogeneity (0=Normal skin color without evidence of hyperpigmentation to 4=Uniform skin involvement without any clear areas). Total Half-Face MASI score was calculated as: Half Forehead 0.15(D+H)A + One Malar Side 0.3 (D+H)A + Half Chin 0.05(D+H)A. A negative change from Baseline indicates improvement.
6 secondary outcomes
Number of Participants by Responses for Self-Assessment Questionnaire: Overall Improvement in Skin Condition
Time frame: Baseline (Day 1) to Weeks 4, 8 and 12
Number of Participants by Responses for Self-Assessment Questionnaire: Overall Satisfaction With the Test Product
Time frame: Weeks 4, 8 and 12
Number of Participants by Responses for Self-Assessment Questionnaire: Test Product Preference
Time frame: Weeks 4, 8 and 12
Change From Baseline in Melasma Quality of Life (MELASQOL) Scale Total Score to Week 12
Time frame: Baseline (Day 1) to Week 12
Investigator's Global Improvement Assessment for Overall Hyperpigmentation Score to Week 12
Time frame: Week 12
Change From Baseline in Mexameter Measurement of Target Hyperpigmentation Lesion to Week 12
Time frame: Baseline (Day 1) to Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Elizabeth Makino study director
Allergan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lytera 2.0, 4% Hydroquinone Topical Cream and SkinMedica Facial Cleanser in people with Melasma, run by Allergan 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 21 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 19 Dec 2018. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Nov 2018). 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 From Baseline in Melasma Severity Rating Scale Score to Week 12 (time frame: Baseline (Day 1) to Week 12). The study lists 3 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 19 Dec 2018.