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

A Randomized Controlled Trial on the Effectiveness of Epidermal Growth Factor-containing Ointment on the Treatment of Solar Lentigines as Adjuvant Therapy

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 Overview

• Status: Completed
• Conditions: Hyperpigmentation; Epidermal Growth Factor; Post Inflammatory Hyperpigmentation; Nd-yttrium Aluminum Garnet Laser
• Intervention / Treatment: Drug: epidermal growth factor (EGF)-containing ointment; Procedure: Q-swithced (QS) 532-nm Nd:yttrium aluminum garnet (YAG) laser; Drug: Vehicle ointment

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • KangNam Sacred Heart Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: epidermal growth factor (EGF) containing ointment group; 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.	Drug: epidermal 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.; Other Names: Easyef Saesal ointment, Daewoong Pharmaceutical Co., Ltd., Seoul, Korea; Procedure: Q-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.; Other Names: Nd:yttrium aluminum garnet laser (Iris, Bluecore Company Co., Ltd., Busan, Korea)
Placebo Comparator: Vehicle ointment group; 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.	Procedure: Q-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.; Other Names: Nd:yttrium aluminum garnet laser (Iris, Bluecore Company Co., Ltd., Busan, Korea); Drug: Vehicle 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.; Other Names: containing petrolatum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Change from baseline pigmentation at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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	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	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	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	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	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	8 weeks

Collaborators and Investigators

• Sponsor: Hallym University Kangnam Sacred Heart Hospital
• Investigators: Study Chair: Bo Young Chung, M.D., PhD, Department of Dermatology, Kangnam Sacred Heart Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2017
• Primary Completion (Actual): September 20, 2018
• Study Completion (Actual): December 26, 2018

Study Registration Dates

• First Submitted: January 5, 2021
• First Submitted That Met QC Criteria: January 7, 2021
• First Posted (Actual): January 11, 2021

Study Record Updates

• Last Update Posted (Actual): January 11, 2021
• Last Update Submitted That Met QC Criteria: January 7, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Melanosis; Lentigo; Hyperpigmentation; Molecular Mechanisms of Pharmacological Action; Mitosis Modulators; Dermatologic Agents; Emollients; Mitogens; Petrolatum
• Other Study ID Numbers: 2017-06-009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No