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Completed

NCT Number: NCT04704245

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

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.

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Key information

Conditions

Epidermal Growth Factor Hyperpigmentation Nd-yttrium Aluminum Garnet Laser Pigmentation Disorders Post Inflammatory Hyperpigmentation Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kangnam Sacred Heart Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

epidermal growth factor (EGF)-containing ointment

Drug

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

Vehicle ointment

Drug

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

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

Procedure

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)

Primary outcomes

  1. Change of pigmentation by physician's assessment

    Time frame: Change from baseline pigmentation at 4 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

  2. Change of pigmentation by physician's assessment

    Time frame: 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 outcomes

  1. Erythema index

    Time frame: baseline

    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. Erythema index

    Time frame: 2 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.

  3. Erythema index

    Time frame: 4 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.

  4. Erythema index

    Time frame: 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.

  5. Melanin index

    Time frame: baseline

    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.

  6. Melanin index

    Time frame: 2 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.

  7. Melanin index

    Time frame: 4 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.

  8. Melanin index

    Time frame: 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.

  9. Transepidermal water loss

    Time frame: baseline

    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

  10. Transepidermal water loss

    Time frame: 2 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

  11. Transepidermal water loss

    Time frame: 4 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

  12. Transepidermal water loss

    Time frame: 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

  13. Patient's subjective satisfaction

    Time frame: 4 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

  14. Patient's subjective satisfaction

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Hallym University Kangnam Sacred Heart Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 11, 2021
Registry last updated
Jan 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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