Solar Lentigines
Conditions
Keywords
Lentigines, Cryotherapy, hyperpigmentation
Brief summary
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.
Detailed description
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.
Interventions
DRUGTri-luma
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.
PROCEDURECryotherapy (CRY-AC3® device)
Procedure performed at week 2.
Sponsors
Hexsel Dermatology Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol; * Female and male subjects; * Phototype II to IV; * Subjects aged between 40 and 65 years; * Subjects presenting at least 5 lesions of solar lentigines at the back hands with al least 3mm of diameter * History of post-inflammatory hyperpigmentation on body or face * Medical history and physical examination which, based on the investigator's opinion, do not prevent the subject from taking part in the study or from making use of the products under investigation; * Subjects of childbearing age should present a negative urine pregnancy test at baseline and should be using a highly effective contraceptive method during all study; * Availability of the subject throughout the study; * Subject agreeing not to undergo other cosmetic or dermatological procedures during the participation in the study; * Subjects with sufficient schooling and knowledge to enable them to cooperate to the degree required by the protocol.
Exclusion criteria
* Pregnant women or women intending to become pregnant in the following 5 months after screening; * Lactation period; * Subjects participating in other clinical trials; * Any prior cosmetic procedures, including fillers, or scars that may interfere with the study results; * Subjects with neoplastic, muscular or neurological diseases; * Subjects with inflammation or active infection in the area to be studied; * Subjects with a history of adverse effects, such as sensitivity to the components of any of the study drug formula, * Subjects with a history of non-adherence to medical treatment or showing unwillingness to adhere to the study protocol; * Any condition that, in the opinion of the investigator, can compromise the evaluation of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Solar Lentigines Count | up to 13 weeks | Solar lentigines count up to 13 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Melanin Levels | Baseline and up to 13 weeks | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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)
* Topical antibiotic treatment (Week 2 to Week 5): All the subjects applied a topical antibiotic (Neomycin/Nebacetin® ointment) for the following 3 weeks.
* Second treatment phase (Week 5 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. | 25 |
| 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)
* Topical antibiotic treatment phase (Week 2 to Week 5): All the subjects applied a topical antibiotic (Neomycin/Nebacetin® ointment) for the next 3 weeks.
* Second treatment phase (Week 5 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. | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | Total | Group 1 | Group 2 |
|---|---|---|---|
| Age, Continuous | 58 years STANDARD_DEVIATION 5 | 59 years STANDARD_DEVIATION 4 | 56 years STANDARD_DEVIATION 6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 49 Participants | 25 Participants | 24 Participants |
| Region of Enrollment Brazil | 50 Participants | 25 Participants | 25 Participants |
| Sex: Female, Male Female | 47 Participants | 23 Participants | 24 Participants |
| Sex: Female, Male Male | 3 Participants | 2 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 3 / 25 | 2 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Solar Lentigines Count
Solar lentigines count up to 13 weeks
Time frame: up to 13 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 | Solar Lentigines Count | Baseline | 25.7 Number of solar lentigines | Standard Deviation 7 |
| Group 1 | Solar Lentigines Count | Week 13 | 8.0 Number of solar lentigines | Standard Deviation 6 |
| Group 2 | Solar Lentigines Count | Baseline | 26.0 Number of solar lentigines | Standard Deviation 11 |
| Group 2 | Solar Lentigines Count | Week 13 | 11.0 Number of solar lentigines | Standard Deviation 6 |
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.
Time frame: Baseline and up to 13 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 | Change From Baseline in Melanin Levels | Baseline | 297 Arbitrary units | Standard Deviation 69 |
| Group 1 | Change From Baseline in Melanin Levels | Change at Week 13 | -95 Arbitrary units | Standard Deviation 59 |
| Group 2 | Change From Baseline in Melanin Levels | Baseline | 279 Arbitrary units | Standard Deviation 68 |
| Group 2 | Change From Baseline in Melanin Levels | Change at Week 13 | -41 Arbitrary units | Standard Deviation 65 |