NCT04704245

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 20, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 26, 2018

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 11, 2021

Completed
Last Updated

January 11, 2021

Status Verified

January 1, 2021

Enrollment Period

1.2 years

First QC Date

January 5, 2021

Last Update Submit

January 7, 2021

Conditions

Epidermal Growth FactorNd-yttrium Aluminum Garnet LaserHyperpigmentationPost Inflammatory Hyperpigmentation

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (14)

  • Erythema index

    baseline

  • Erythema index

    2 weeks

  • Erythema index

    4 weeks

  • Erythema index

    8 weeks

  • Melanin index

    baseline

  • +9 more secondary outcomes

Study Arms (2)

epidermal growth factor (EGF) containing ointment group

EXPERIMENTAL

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

Vehicle ointment group

PLACEBO COMPARATOR

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.

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

Interventions

epidermal growth factor (EGF)-containing ointmentDRUG

The subjects applied the epidermal growth factor (EGF) ointment twice daily (morning and evening) to the lesion for 4 weeks after laser treatment.

Also known as: Easyef Saesal ointment, Daewoong Pharmaceutical Co., Ltd., Seoul, Korea
epidermal growth factor (EGF) containing ointment group
Vehicle ointmentDRUG

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.

Also known as: containing petrolatum
Vehicle ointment group
Q-swithced (QS) 532-nm Nd:yttrium aluminum garnet (YAG) laserPROCEDURE

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.

Also known as: Nd:yttrium aluminum garnet laser (Iris, Bluecore Company Co., Ltd., Busan, Korea)
Vehicle ointment groupepidermal growth factor (EGF) containing ointment group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of solar lentigines that occurred after adulthood
  • age of 20 years or older.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kangnam Sacred Heart Hospital

Seoul, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 33668564DERIVED

MeSH Terms

Conditions

Hyperpigmentation

Interventions

Epidermal Growth FactorLong-Term Synaptic DepressionLasersBRCA1 Protein

Condition Hierarchy (Ancestors)

Pigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Gastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsEGF Family of ProteinsIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsNeuronal PlasticityNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaOptical DevicesEquipment and SuppliesRadiation Equipment and SuppliesFanconi Anemia Complementation Group ProteinsTumor Suppressor ProteinsNeoplasm ProteinsNuclear ProteinsPhosphoproteinsTranscription Factors

Study Officials

  • Bo Young Chung, M.D., PhD

    Department of Dermatology, Kangnam Sacred Heart Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

January 5, 2021

First Posted

January 11, 2021

Study Start

July 20, 2017

Primary Completion

September 20, 2018

Study Completion

December 26, 2018

Last Updated

January 11, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)