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

Not Applicable

Completed

• Conditions: Nd-yttrium Aluminum Garnet Laser; Post Inflammatory Hyperpigmentation; Epidermal Growth Factor; Hyperpigmentation
• Interventions: Drug: epidermal growth factor (EGF)-containing ointment; Drug: Vehicle ointment

• Registration Number: NCT04704245
• Lead Sponsor: Hallym University Kangnam Sacred Heart Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-20
• Primary Completion: 2018-09-20
• Study Completion: 2018-12-26
• Status Verified: 2021-01
• Study First Submitted: 2021-01-05
• Study First Submitted QC: 2021-01-07
• Last Update Submitted: 2021-01-07
• Study First Posted: 2021-01-11
• Last Update Posted: 2021-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
epidermal growth factor (EGF) containing ointment group	epidermal growth factor (EGF)-containing ointment	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.
Vehicle ointment group	Vehicle ointment	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.

Primary Outcome Measures

Name	Time	Method
Change of pigmentation by physician's assessment	Change from baseline pigmentation at 8 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 Outcome Measures

Name	Time	Method
Erythema index	8 weeks	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.
Transepidermal water loss	8 weeks	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	8 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
Melanin index	8 weeks	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.

Trial Locations

Locations (1)

Kangnam Sacred Heart Hospital; 🇰🇷 Seoul, Korea, Republic of