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

NCT04704245 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-01-11

No results posted yet for this study

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.

Conditions

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

Interventions

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.

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.

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.

Sponsors & Collaborators

  • Hallym University Kangnam Sacred Heart Hospital

    lead OTHER

Principal Investigators

  • Bo Young Chung, M.D., PhD · Department of Dermatology, Kangnam Sacred Heart Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-20
Primary Completion
2018-09-20
Completion
2018-12-26

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04704245 on ClinicalTrials.gov