Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate safety and efficacy of Tri-Luma® cream as an adjunctive treatment to cryotherapy when used in the pre- and post-procedure phases for the treatment of solar lentigines on the back of the hands and in the prevention of post-inflammatory hyperpigmentation after cryotherapy.
To evaluate safety and efficacy of Tri-Luma® cream as an adjunctive treatment to cryotherapy when used in the pre- and post-procedure phases for the treatment of solar lentigines on the back of the hands and in the prevention of post-inflammatory hyperpigmentation after cryotherapy.
The study has 13 weeks for each subject. Five visits will take place: at Baseline, week 2, 5, 9 and 13 after the cryotherapy.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | Subjects (group 1) will be treated daily for their solar lentigines with the investigational drug (Tri-Luma® cream) plus sunscreen for 2 weeks. At week 2, all the subjects will have the solar lentigines treated by cryotherapy (CRY-AC3® device). Post-procedure phase (From Week 2 up to Week 13)
The investigational drug (Tri-Luma® cream) plus sunscreen will be applied again (group 1) for a minimum of 4 weeks and up to 8 weeks, according to the Global Improvement of solar lentigines and absence of PIH. |
|
| Group 2 | Placebo Comparator | Subjects (group 2) will be treated daily for their solar lentigines with sunscreen alone for 2 weeks. At week 2, all the subjects will have the solar lentigines will treated by cryotherapy (CRY-AC3® device). Post-procedure phase (Week 2 up to Week 13)
Sunscreen alone will be applied again (group 1) for a minimum of 4 weeks and up to 8 weeks, according to the Global Improvement of solar lentigines and absence of PIH. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tri-luma | Drug | Pre-procedure phase (From Baseline up to Week 2) treated daily for their solar lentigines with the investigational drug (Tri-Luma® cream) for 2 weeks. Post-procedure phase (From week 2 up to Week 13 - Visit ) - Tri-Luma® cream treatment phase (from week 5 up to week 13 - visit 3 up to visit 5):The investigational drug (Tri-Luma® cream) will be applied again (group 1) for a minimum of 4 weeks and up to 8 weeks, according to the Global Improvement of solar lentigines and absence of PIH. |
| Measure | Description | Time Frame |
|---|---|---|
| Solar Lentigines Count | Solar lentigines count up to 13 weeks | up to 13 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Melanin Levels | This assessment was made using a narrowband reflectance spectrophotometer (Mexameter MX18®, Courage-Khazaka, Germany). The measurement is based on absorption/reflection. The probe of the Mexameter® MX 18 emits three specific light wavelengths. A receiver measures the light reflected by the skin. As the quantity of emitted light is defined, the quantity of light absorbed by the skin can be calculated. The melanin is measured by two specific wavelengths (red: 660 nm and near infrared: 880 nm) chosen to correspond to different absorption rates by the pigments. The quantification of melanin is presented as a value that varies from 0-999. The higher the value, the larger is the amount of melanin on the skin. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Doris Hexsel, MD | Brazilian Center for Studies in Dermatology | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 | Subjects treated daily for their solar lentigines with the triple combination (hydroquinone 4% tretinoin 0.05% fluocinolone acetonide 0.01%; Tri-Luma® cream) plus sunscreen for 2 weeks. At week 2, all the subjects had the solar lentigines treated by cryotherapy (CRY-AC3® device). Post-procedure phase (Week 2 up to Week 13)
Subjects of group 1 applied Tri-Luma® cream plus sunscreen again for a minimum of 4 weeks and up to 8 weeks, depending on the Global Improvement of solar lentigines score and absence of post inflammatory hyperpigmentation. |
| FG001 | Group 2 | Subjects treated daily for their solar lentigines with sunscreen only for 2 weeks. At week 2, all the subjects had the solar lentigines treated by cryotherapy (CRY-AC3® device). Post-procedure phase (Week 2 up to Week 13)
Subjects of group 2 applied sunscreen only again for a minimum of 4 weeks and up to 8 weeks, depending on the Global Improvement of solar lentigines score and absence of post inflammatory hyperpigmentation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | Subjects treated daily for their solar lentigines with the triple combination (hydroquinone 4% tretinoin 0.05% fluocinolone acetonide 0.01%; Tri-Luma® cream) plus sunscreen for 2 weeks. At week 2, all the subjects had the solar lentigines treated by cryotherapy (CRY-AC3® device). Post-procedure phase (Week 2 up to Week 13)
Subjects of group 1 applied Tri-Luma® cream plus sunscreen again for a minimum of 4 weeks and up to 8 weeks, depending on the Global Improvement of solar lentigines score and absence of PIH. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Solar Lentigines Count | Solar lentigines count up to 13 weeks | Posted | Mean | Standard Deviation | Number of solar lentigines | up to 13 weeks |
|
Up to 13 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 | Subjects treated daily for their solar lentigines with the triple combination (hydroquinone 4% tretinoin 0.05% fluocinolone acetonide 0.01%; Tri-Luma® cream) plus sunscreen for 2 weeks. At week 2, all the subjects had the solar lentigines treated by cryotherapy (CRY-AC3® device). Post-procedure phase (Week 2 up to Week 13)
Subjects of group 1 applied Tri-Luma® cream plus sunscreen again for a minimum of 4 weeks and up to 8 weeks, depending on the Global Improvement of solar lentigines score and absence of PIH. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Doris Hexsel | Brazilian Center for Studies in Dermatology | +55 51 30262633 | doris@hexsel.com.br |
Not provided
| ID | Term |
|---|---|
| D007911 | Lentigo |
| D017495 | Hyperpigmentation |
| ID | Term |
|---|---|
| D008548 | Melanosis |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D017679 | Cryotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Cryotherapy (CRY-AC3® device) | Procedure | Procedure performed at week 2. |
|
| Baseline and up to 13 weeks |
| BG001 | Group 2 | Subjects treated daily for their solar lentigines with sunscreen only for 2 weeks. At week 2, all the subjects had the solar lentigines treated by cryotherapy (CRY-AC3® device). Post-procedure phase (Week 2 up to Week 13)
Subjects of group 2 applied sunscreen only again for a minimum of 4 weeks and up to 8 weeks, depending on the Global Improvement of solar lentigines score and absence of PIH. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 |
| Group 2 |
Subjects treated daily for their solar lentigines with sunscreen only for 2 weeks. At week 2, all the subjects had the solar lentigines treated by cryotherapy (CRY-AC3® device). Post-procedure phase (Week 2 up to Week 13)
Subjects of group 2 applied sunscreen only again for a minimum of 4 weeks and up to 8 weeks, depending on the Global Improvement of solar lentigines score and absence of PIH. |
|
|
| Secondary | Change From Baseline in Melanin Levels | This assessment was made using a narrowband reflectance spectrophotometer (Mexameter MX18®, Courage-Khazaka, Germany). The measurement is based on absorption/reflection. The probe of the Mexameter® MX 18 emits three specific light wavelengths. A receiver measures the light reflected by the skin. As the quantity of emitted light is defined, the quantity of light absorbed by the skin can be calculated. The melanin is measured by two specific wavelengths (red: 660 nm and near infrared: 880 nm) chosen to correspond to different absorption rates by the pigments. The quantification of melanin is presented as a value that varies from 0-999. The higher the value, the larger is the amount of melanin on the skin. | Posted | Mean | Standard Deviation | Arbitrary units | Baseline and up to 13 weeks |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 3 |
| 25 |
| EG001 | Group 2 | Subjects treated daily for their solar lentigines with sunscreen only for 2 weeks. At week 2, all the subjects had the solar lentigines treated by cryotherapy (CRY-AC3® device). Post-procedure phase (Week 2 up to Week 13)
Subjects of group 2 applied sunscreen only again for a minimum of 4 weeks and up to 8 weeks, depending on the Global Improvement of solar lentigines score and absence of PIH. | 0 | 25 | 0 | 25 | 2 | 25 |
| Residual blisters from cryotherapy | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
Not provided
Not provided