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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
The subjects applied the epidermal growth factor (EGF) ointment twice daily (morning and evening) to the lesion for 4 weeks after laser treatment.
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.
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.
Kangnam Sacred Heart Hospital
Seoul, South Korea
Change of pigmentation by physician's assessment
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
Time frame: Change from baseline pigmentation at 4 weeks
Change of pigmentation by physician's assessment
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
Time frame: Change from baseline pigmentation at 8 weeks
Erythema index
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.
Time frame: baseline
Erythema index
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.
Time frame: 2 weeks
Erythema index
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.
Time frame: 4 weeks
Erythema index
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.
Time frame: 8 weeks
Melanin index
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.
Time frame: baseline
Melanin index
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.
Time frame: 2 weeks
Melanin index
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.
Time frame: 4 weeks
Melanin index
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.
Time frame: 8 weeks
Transepidermal water loss
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
Time frame: baseline
Transepidermal water loss
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
Time frame: 2 weeks
Transepidermal water loss
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
Time frame: 4 weeks
Transepidermal water loss
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
Time frame: 8 weeks
Patient's subjective satisfaction
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
Time frame: 4 weeks
Patient's subjective satisfaction
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
Time frame: 8 weeks
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