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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Erythema index |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bo Young Chung, M.D., PhD | Department of Dermatology, Kangnam Sacred Heart Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kangnam Sacred Heart Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33668564 | Derived | 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. |
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|
| 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. |
|
|
| 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. |
|
|
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| ID | Term |
|---|---|
| D017495 | Hyperpigmentation |
| ID | Term |
|---|---|
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D004815 | Epidermal Growth Factor |
| D036881 | Long-Term Synaptic Depression |
| D007834 | Lasers |
| D019313 | BRCA1 Protein |
| ID | Term |
|---|---|
| D005768 | Gastrointestinal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D066255 | EGF Family of Proteins |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D009473 | Neuronal Plasticity |
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
| D051856 | Fanconi Anemia Complementation Group Proteins |
| D025521 | Tumor Suppressor Proteins |
| D009363 | Neoplasm Proteins |
| D009687 | Nuclear Proteins |
| D010750 | Phosphoproteins |
| D014157 | Transcription Factors |
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