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

Hyperpigmentation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04704245
• Other study ID #: 2017-06-009
• Status: Completed
• Phase: N/A
• Start date: July 20, 2017
• Est. completion date: December 26, 2018

Study information

• Verified date: January 2021
• Source: Hallym University Kangnam Sacred Heart Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 26, 2018
• Est. primary completion date: September 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Epidermal Growth Factor
• Hyperpigmentation
• Lentigo
• Nd-yttrium Aluminum Garnet Laser
• Post Inflammatory Hyperpigmentation

Intervention

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.
• 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.

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.

Locations

Country	Name	City	State
Korea, Republic of	Kangnam Sacred Heart Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hallym University Kangnam Sacred Heart Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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