Epidermal Growth FactorNCT04704245
Effectiveness of Epidermal Growth Factor-containing Ointment on the Solar Lentigines
A study testing epidermal growth factor (EGF)-containing ointment and Q-swithced (QS) 532-nm Nd:yttrium aluminum garnet (YAG) laser in people with Epidermal Growth Factor and Nd-yttrium Aluminum Garnet Laser, run by Hallym University Kangnam Sacred Heart Hospital at 1 site in South Korea.
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). Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Epidermal Growth Factor, Nd-yttrium Aluminum Garnet Laser, Hyperpigmentation
- What is being tested?
- epidermal growth factor (EGF)-containing ointment and Q-swithced (QS) 532-nm Nd:yttrium aluminum garnet (YAG) laser
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Jul 2017to 26 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of solar lentigines that occurred after adulthood
- age of 20 years or older.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial on the Effectiveness of Epidermal Growth Factor-containing Ointment on the Treatment of Solar Lentigines as Adjuvant Therapy
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
- Being tested
- epidermal growth factor (EGF)-containing ointment, Vehicle ointment, Q-swithced (QS) 532-nm Nd:yttrium aluminum garnet (YAG) laser
- Medical subject headings
- Hyperpigmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epidermal growth factor (EGF)-containing ointmentDrug
Also called Easyef Saesal ointment, Daewoong Pharmaceutical Co., Ltd., Seoul, Korea
The subjects applied the epidermal growth factor (EGF) ointment twice daily (morning and evening) to the lesion for 4 weeks after laser treatment.
Vehicle ointmentDrug
Also called containing petrolatum
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.
Q-swithced (QS) 532-nm Nd:yttrium aluminum garnet (YAG) laserProcedure or surgery
Also called Nd:yttrium aluminum garnet laser (Iris, Bluecore Company Co., Ltd., Busan, Korea)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: epidermal growth factor (EGF)-containing ointment; Procedure: 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. Receives: Drug: Vehicle ointment; Procedure: Q-swithced (QS) 532-nm Nd:yttrium aluminum garnet (YAG) laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Change from baseline pigmentation at 8 weeks
Secondary outcomes (14)
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.
Measured: baseline
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.
Measured: 2 weeks
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.
Measured: 4 weeks
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.
Measured: 8 weeks
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.
Measured: baseline
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.
Measured: 2 weeks
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.
Measured: 4 weeks
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.
Measured: 8 weeks
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
Measured: baseline
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
Measured: 2 weeks
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
Measured: 4 weeks
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
Measured: 8 weeks
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
Measured: 4 weeks
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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start20 Jul 2017
- Primary completion20 Sep 2018
- Study completion26 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Epidermal Growth FactorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hallym University Kangnam Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bo Young Chung, Hallym University Kangnam Sacred Heart Hospital
- Investigators
- Bo Young Chung, M.D., PhD, Study chair, Department of Dermatology, Kangnam Sacred Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04704245
- Sponsor's protocol ID
- 2017-06-009
- Status last verified
- Jan 2021
- First submitted
- 5 Jan 2021
- Last updated
- 11 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33668564
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial on the Effectiveness of Epidermal Growth Factor-containing Ointment on the Treatment of Solar Lentigines as Adjuvant Therapy
- ClinicalTrials.gov ID
- NCT04704245
- Acronym / sponsor ID
- 2017-06-009
- Conditions
- Epidermal Growth Factor, Nd-yttrium Aluminum Garnet Laser, Hyperpigmentation, Post Inflammatory Hyperpigmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hallym University Kangnam Sacred Heart HospitalUniversity, hospital or other
- Study start
- 20 Jul 2017 (actual)
- Primary completion
- 20 Sep 2018 (actual)
- Study completion
- 26 Dec 2018 (actual)
- First posted
- 11 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| epidermal growth factor (EGF) containing ointment group | Experimental | Drug: epidermal growth factor (EGF)-containing ointment, Procedure: Q-swithced (QS) 532-nm Nd:yttrium aluminum garnet (YAG) laserThe 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. |
| Vehicle ointment group | Placebo comparator | Drug: Vehicle ointment, Procedure: Q-swithced (QS) 532-nm Nd:yttrium aluminum garnet (YAG) laserThe 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of solar lentigines that occurred after adulthood
- age of 20 years or older.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| epidermal growth factor (EGF)-containing ointmentAlso: Easyef Saesal ointment, Daewoong Pharmaceutical Co., Ltd., Seoul, KoreaThe subjects 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 ointment group |
| Vehicle ointmentAlso: containing petrolatumTo 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. | Drug | Vehicle ointment group |
| Q-swithced (QS) 532-nm Nd:yttrium aluminum garnet (YAG) laserAlso: Nd:yttrium aluminum garnet laser (Iris, Bluecore Company Co., Ltd., Busan, Korea)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. | Procedure or surgery | Vehicle ointment group, epidermal growth factor (EGF) containing ointment group |
Primary outcome
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
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
14 secondary outcomes
Erythema index
Time frame: baseline
Erythema index
Time frame: 2 weeks
Erythema index
Time frame: 4 weeks
Erythema index
Time frame: 8 weeks
Melanin index
Time frame: baseline
Melanin index
Time frame: 2 weeks
Melanin index
Time frame: 4 weeks
Melanin index
Time frame: 8 weeks
Transepidermal water loss
Time frame: baseline
Transepidermal water loss
Time frame: 2 weeks
Transepidermal water loss
Time frame: 4 weeks
Transepidermal water loss
Time frame: 8 weeks
Patient's subjective satisfaction
Time frame: 4 weeks
Patient's subjective satisfaction
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2021.
- Derived from this study: PubMed 33668564Kim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bo Young Chung, M.D., PhD study chair
Department of Dermatology, Kangnam Sacred Heart Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing epidermal growth factor (EGF)-containing ointment and Q-swithced (QS) 532-nm Nd:yttrium aluminum garnet (YAG) laser in people with Epidermal Growth Factor and Nd-yttrium Aluminum Garnet Laser, run by Hallym University Kangnam Sacred Heart Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of pigmentation by physician's assessment (time frame: Change from baseline pigmentation at 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04704245, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2021.