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

Primary Purpose

Epidermal Growth Factor, Nd-yttrium Aluminum Garnet Laser, Hyperpigmentation

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
epidermal growth factor (EGF)-containing ointment
Vehicle ointment
Q-swithced (QS) 532-nm Nd:yttrium aluminum garnet (YAG) laser
Sponsored by
Hallym University Kangnam Sacred Heart Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epidermal Growth Factor

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Kangnam Sacred Heart Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

epidermal growth factor (EGF) containing ointment group

Vehicle ointment group

Arm 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.

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.

Outcomes

Primary Outcome Measures

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 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

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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
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
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
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
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
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

Full Information

First Posted
January 5, 2021
Last Updated
January 7, 2021
Sponsor
Hallym University Kangnam Sacred Heart Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04704245
Brief Title
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

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
July 20, 2017 (Actual)
Primary Completion Date
September 20, 2018 (Actual)
Study Completion Date
December 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hallym University Kangnam Sacred Heart Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epidermal Growth Factor, Nd-yttrium Aluminum Garnet Laser, Hyperpigmentation, Post Inflammatory Hyperpigmentation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
epidermal growth factor (EGF) containing ointment group
Arm Type
Experimental
Arm 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.
Arm Title
Vehicle ointment group
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
epidermal growth factor (EGF)-containing ointment
Other Intervention Name(s)
Easyef Saesal ointment, Daewoong Pharmaceutical Co., Ltd., Seoul, Korea
Intervention Description
The subjects applied the epidermal growth factor (EGF) ointment twice daily (morning and evening) to the lesion for 4 weeks after laser treatment.
Intervention Type
Drug
Intervention Name(s)
Vehicle ointment
Other Intervention Name(s)
containing petrolatum
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Q-swithced (QS) 532-nm Nd:yttrium aluminum garnet (YAG) laser
Other Intervention Name(s)
Nd:yttrium aluminum garnet laser (Iris, Bluecore Company Co., Ltd., Busan, Korea)
Intervention 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.
Primary Outcome Measure Information:
Title
Change of pigmentation by physician's assessment
Description
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
Title
Change of pigmentation by physician's assessment
Description
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
Secondary Outcome Measure Information:
Title
Erythema index
Description
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
Title
Erythema index
Description
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
Title
Erythema index
Description
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
Title
Erythema index
Description
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
Title
Melanin index
Description
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
Title
Melanin index
Description
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
Title
Melanin index
Description
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
Title
Melanin index
Description
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
Title
Transepidermal water loss
Description
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
Title
Transepidermal water loss
Description
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
Title
Transepidermal water loss
Description
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
Title
Transepidermal water loss
Description
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
Title
Patient's subjective satisfaction
Description
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
Title
Patient's subjective satisfaction
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bo Young Chung, M.D., PhD
Organizational Affiliation
Department of Dermatology, Kangnam Sacred Heart Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Kangnam Sacred Heart Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33668564
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.
Results Reference
derived

Learn more about this trial

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

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