Effectiveness of Epidermal Growth Factor-containing Ointment on the Solar Lentigines

Hallym University Kangnam Sacred Heart Hospital

Status: Completed

Conditions: Nd-yttrium Aluminum Garnet Laser; Post Inflammatory Hyperpigmentation; Hyperpigmentation; Epidermal Growth Factor

Treatments: Drug: epidermal growth factor (EGF)-containing ointment; Drug: Vehicle ointment; Procedure: Q-swithced (QS) 532-nm Nd:yttrium aluminum garnet (YAG) laser

Study type: Interventional

Funder types: Other

Identifiers

NCT04704245

2017-06-009

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups, including a placebo group

epidermal growth factor (EGF) containing ointment group

Experimental group

Description:

The subjects received one session of laser treatment with a Q-swithced (QS) 532-nm Nd:yttrium aluminum garnet (YAG) laser 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. The subjects then applied the epidermal growth factor (EGF) ointment twice daily (morning and evening) to the lesion for 4 weeks after laser treatment.

Treatment:

Procedure: Q-swithced (QS) 532-nm Nd:yttrium aluminum garnet (YAG) laser

Drug: epidermal growth factor (EGF)-containing ointment

Vehicle ointment group

Placebo Comparator group

Description:

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. The subjects then applied the vehicle ointment twice daily (morning and evening) to the lesion for 4 weeks after laser treatment.

Treatment:

Procedure: Q-swithced (QS) 532-nm Nd:yttrium aluminum garnet (YAG) laser

Drug: Vehicle ointment