Epidermal Growth Factor, Nd-yttrium Aluminum Garnet Laser, Hyperpigmentation, Post Inflammatory Hyperpigmentation
Conditions
Brief summary
Subjects were randomly assigned to groups for treatment with either an EGF-containing ointment (the study group) or the vehicle alone (petrolatum; the control group). The EGF ointment included recombinant human EGF (1 μg/g). Random numbers used for assignment to groups were provided by the randomization function of SAS. The subjects received one session of laser treatment with a Q-switched (QS) 532-nm Nd:yttrium aluminum garnet (YAG) laser of their solar lentigines after enrollment. . The end point of laser treatment for lentigines was immediate whitening. The subjects then applied the EGF ointment or vehicle twice daily (morning and evening) to the lesion for 4 weeks after laser treatment.
Interventions
DRUGepidermal growth factor (EGF)-containing ointment
The subjects applied the epidermal growth factor (EGF) ointment twice daily (morning and evening) to the lesion for 4 weeks after laser treatment.
DRUGVehicle ointment
To compare the effect of epidermal growth factor (EGF) ointment, the control subjects applied the vehicle ointment twice daily (morning and evening) to the lesion for 4 weeks after laser treatment.
PROCEDUREQ-swithced (QS) 532-nm Nd:yttrium aluminum garnet (YAG) laser
The subjects received one session of laser treatment with a Q-swithced (QS) 532-nm Nd:yttrium aluminum garnet (YAG) laser of their solar lentigines after enrollment. The procedure parameters were as follows: 5-10-ns pulse duration, 3.5-mm spot size, 0.9-1.1-J/cm2 fluence, and 2-Hz frequency. The end point of laser treatment for lentigines was immediate whitening.
Sponsors
Hallym University Kangnam Sacred Heart Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Clinical diagnosis of solar lentigines that occurred after adulthood * age of 20 years or older.
Exclusion criteria
* uncontrolled systemic or chronic disease * hypersensitivity to the ingredients of the ointment * current use of skin whitening agents * a history of other laser treatments within the past 6 months * pregnancy * lactation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of pigmentation by physician's assessment | Change from baseline pigmentation at 4 weeks | The pigment clearance was assessed using a 5-grade percentage improvement scale grade 1, \<0% \[worse\]; grade 2, 0%-25% improvement; grade 3, 26%-50% improvement; grade 4, 51%-75% improvement; grade 5, 76%-100% improvement -\> higher score means better outcomes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Erythema index | baseline | A spectrophotometer was used to assess the lesion in a room at constant temperature (20-24 °C) and humidity (28%-38%). Skin measurements were performed to determine erythema. |
| Melanin index | baseline | A spectrophotometer was used to assess the lesion in a room at constant temperature (20-24 °C) and humidity (28%-38%). Skin measurements were performed to determine pigmentation. |
| Transepidermal water loss | baseline | A VapoMeter®(Delfin Technologies Ltd., Kuopio, Finland) was used to assess the lesion in a room at constant temperature (20-24 °C) and humidity (28%-38%). Skin measurements were performed to determine transepidermal water loss |
| Patient's subjective satisfaction | 4 weeks | The patient's subjective satisfaction was assessed by questionnaire according to the following: 1, worse; 2, no change; 3, mild improvement; 4, moderate improvement; or 5, significant improvement. higher score means better outcome |
Countries
South Korea
Outcome results
None listed