Clinical trial NCT04704245: Effectiveness of Epidermal Growth Factor-containing Ointment on the Solar Lentigines
Official title: A Randomized Controlled Trial on the Effectiveness of Epidermal Growth Factor-containing Ointment on the Treatment of Solar Lentigines as Adjuvant Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epidermal Growth Factor
Nd-yttrium Aluminum Garnet Laser
Hyperpigmentation
Post Inflammatory Hyperpigmentation
Lead sponsor: Hallym University Kangnam Sacred Heart Hospital
Sponsor class: OTHER
First posted: 2021-01-11
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change of pigmentation by physician's assessment
timeFrame: Change from baseline pigmentation at 4 weeks
measure: Change of pigmentation by physician's assessment
timeFrame: Change from baseline pigmentation at 8 weeks
Secondary outcomes:
measure: Erythema index
timeFrame: baseline
measure: Erythema index
timeFrame: 2 weeks
measure: Erythema index
timeFrame: 4 weeks
measure: Erythema index
timeFrame: 8 weeks
measure: Melanin index
timeFrame: baseline
measure: Melanin index
timeFrame: 2 weeks
measure: Melanin index
timeFrame: 4 weeks
measure: Melanin index
timeFrame: 8 weeks
measure: Transepidermal water loss
timeFrame: baseline
measure: Transepidermal water loss
timeFrame: 2 weeks
measure: Transepidermal water loss
timeFrame: 4 weeks
measure: Transepidermal water loss
timeFrame: 8 weeks
measure: Patient's subjective satisfaction
timeFrame: 4 weeks
measure: Patient's subjective satisfaction
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangnam Sacred Heart Hospital
Study officials:
affiliation: Department of Dermatology, Kangnam Sacred Heart Hospital
name: Bo Young Chung, M.D., PhD
role: STUDY_CHAIR
References:
citation: Kim HO, Kim HR, Kim JC, Kang SY, Jung MJ, Chang SE, Park CW, Chung BY. A Randomized Controlled Trial on the Effectiveness of Epidermal Growth Factor-Containing Ointment on the Treatment of Solar Lentigines as Adjuvant Therapy. Medicina (Kaunas). 2021 Feb 13;57(2):166. doi: 10.3390/medicina57020166.