Trial Outcomes & Findings for A Fixed Triple Combination Cream for Solar Lentigines Associated to Cryotherapy (NCT NCT01778179)
NCT ID: NCT01778179
Last Updated: 2020-10-14
Results Overview
Solar lentigines count up to 13 weeks
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
up to 13 weeks
Results posted on
2020-10-14
Participant Flow
Participant milestones
| Measure |
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 post inflammatory hyperpigmentation.
|
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 post inflammatory hyperpigmentation.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
23
|
22
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Fixed Triple Combination Cream for Solar Lentigines Associated to Cryotherapy
Baseline characteristics by cohort
| Measure |
Group 1
n=25 Participants
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.
|
Group 2
n=25 Participants
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.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59 years
STANDARD_DEVIATION 4 • n=5 Participants
|
56 years
STANDARD_DEVIATION 6 • n=7 Participants
|
58 years
STANDARD_DEVIATION 5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 13 weeksSolar lentigines count up to 13 weeks
Outcome measures
| Measure |
Group 1
n=23 Participants
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.
|
Group 2
n=22 Participants
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.
|
|---|---|---|
|
Solar Lentigines Count
Baseline
|
25.7 Number of solar lentigines
Standard Deviation 7.0
|
26.0 Number of solar lentigines
Standard Deviation 11.0
|
|
Solar Lentigines Count
Week 13
|
8.0 Number of solar lentigines
Standard Deviation 6.0
|
11.0 Number of solar lentigines
Standard Deviation 6.0
|
SECONDARY outcome
Timeframe: Baseline and up to 13 weeksThis 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.
Outcome measures
| Measure |
Group 1
n=23 Participants
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.
|
Group 2
n=22 Participants
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.
|
|---|---|---|
|
Change From Baseline in Melanin Levels
Baseline
|
297 Arbitrary units
Standard Deviation 69
|
279 Arbitrary units
Standard Deviation 68
|
|
Change From Baseline in Melanin Levels
Change at Week 13
|
-95 Arbitrary units
Standard Deviation 59
|
-41 Arbitrary units
Standard Deviation 65
|
Adverse Events
Group 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Group 2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1
n=25 participants at risk
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.
|
Group 2
n=25 participants at risk
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.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Erythema
|
12.0%
3/25 • Up to 13 weeks
|
8.0%
2/25 • Up to 13 weeks
|
|
Skin and subcutaneous tissue disorders
Residual blisters from cryotherapy
|
4.0%
1/25 • Up to 13 weeks
|
4.0%
1/25 • Up to 13 weeks
|
Additional Information
Dr. Doris Hexsel
Brazilian Center for Studies in Dermatology
Phone: +55 51 30262633
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place