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Keloids are thought to result from derailments in the typical wound healing process following cutaneous injury. Current treatment options for keloids include intralesional corticosteroids, silicone gel sheeting, compression, surgery and adjuvants to surgery, including radiation and cryotherapy.
0.5% hydrocortisone, silicone, vitamin E lotion (HSE) and onion extract gel (OE) are widely used over-the-counter medications for the treatment of keloids and hypertrophic scars. However, their efficacy and safety have not been compared in a blinded, placebo-controlled, prospective fashion. This study is being undertaken to determine the efficacy and safety of HSE versus OE versus placebo (Cetearyl alcohol; CEA) in subjects with hypertrophic scars and keloids.
This is an investigator-blinded study, which means that the doctor evaluating you will not know if you are receiving the study medication or not. Another doctor will be supplying you with the medication and discussing any problems that you may have with the medication.
You will be assigned to one of the three treatment groups: HSE, OE, or CEA. The group will be assigned by chance and you will have two in three chances of receiving treatment with a study medication, HSE or OE. The no treatment group will receive CEA, a bland lotion, containing no active ingredients such as steroids, silicone, vitamin E, or onion extract.
This study will last up to 16 weeks, with a total of 5 visits to the clinic (Baseline visit, Week 4, 8, 12, and 16 ), excluding the Screening Visit.
Screening Visit/Baseline Visit:
Patients will read and be explained the informed consent. Patients who agree to participate will sign the informed consent and a copy will be given to them. Medical history and exclusion/inclusion criteria will be reviewed; if a patient qualifies he/she will be assigned a randomization number for the treatment.
At the baseline visit, medical history and exclusion/inclusion criteria since the screening visit will be reviewed. Patients randomized to the HSE group will receive one tube and apply the first application to the keloid/hypertrophic scar during the baseline visit. Patients randomized to the OE group will be given a tube of OE gel and will apply the first application to the keloid/hypertrophic scar. Patients in the placebo group will be given a bottle of CEA lotion, the placebo medication, and will apply the first application to the keloid/hypertrophic scar. The medications will be given by the unblinded investigator and the blinded investigator will be evaluating the patients. Photographs of the patient's keloid/hypertrophic scar will be taken, and the keloid/hypertrophic scar will be measured/assessed according to Methods of Study Lesion Assessment (below). A urine pregnancy test will be obtained for all women of child-bearing potential.
Week 4, 8, 12, and 16 Visit:
Patients will be asked about side effects since last visit. Photographs of the patient's keloid/hypertrophic scar will be taken and the keloid/hypertrophic scar will be measured/assessed according to Methods of Study Lesion Assessment (below). A urine pregnancy test will be obtained at for all women of child-bearing potential.
Methods of Study Lesion Assessment
A. Volume B. Linear dimensions
Investigator's Assessments w/ Visual Analog Scale (VAS):
C. Cosmetic assessment D. Induration (hardness) [compared to standardized hard discs with numerical ranking of increased induration] E. Erythema (redness) F. Pigmentary alteration
Patient's Assessments w/ VAS:
G. Cosmetic assessment H. Pain I. Tenderness J. Pruritus (itching) K. Patient satisfaction
L. Digital photographs
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regimen A | Experimental | 0.5% hydrocortisone, silicone, vitamin E lotion |
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| Regimen B | Experimental | Onion extract gel |
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| Regimen C | Placebo Comparator | Cetearyl alcohol lotion |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.5% hydrocortisone, silicone, vitamin E lotion | Drug | 0.5% hydrocortisone, silicone, vitamin E lotion will be applied topically to cover the selected scar twice daily for 16 weeks. The lesion will be cleansed with soap and water and dried thoroughly. The medication will be applied with a brush and allow it to dry for one minute before contact with clothing. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Lesion Volume | Blinded investigator assessed the scar volume by using an alginate impression. | Assessed at Baseline visit (week 0) and week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Lesion Length | Blinded investigator assessed the scar length. Measured with ruler, from scar tip to tip. | Assessed at Baseline visit (week 0) and week 16 |
| Change in Lesion Width | Blinded investigator assessed the scar width. Measured with a ruler at the visually largest width. |
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Inclusion Criteria:
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
Exclusion Criteria:
Subjects who meet any of the following criteria should be excluded from the study:
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| Name | Affiliation | Role |
|---|---|---|
| Brian Berman, M.D., Ph.D | University of Miami, Department of Dermatology and Cutaneous Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Skin Research Group Office | Miami | Florida | 33136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8979497 | Background | Augusti KT. Therapeutic values of onion (Allium cepa L.) and garlic (Allium sativum L.). Indian J Exp Biol. 1996 Jul;34(7):634-40. | |
| 12087249 | Background | Saulis AS, Mogford JH, Mustoe TA. Effect of Mederma on hypertrophic scarring in the rabbit ear model. Plast Reconstr Surg. 2002 Jul;110(1):177-83; discussion 184-6. doi: 10.1097/00006534-200207000-00029. |
| Label | URL |
|---|---|
| Skin Research Group Website | View source |
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Detailed enrollment data for participants is not available for week 4, 8, and 12.
Reason participants did not complete study are not available for reporting.
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| ID | Title | Description |
|---|---|---|
| FG000 | 0.5% Hydrocortisone, Silicone, Vitamin E Lotion (HSE ) | 0.5% hydrocortisone, silicone, vitamin E lotion 0.5% hydrocortisone, silicone, vitamin E lotion: 0.5% hydrocortisone, silicone, vitamin E lotion will be applied topically to cover the selected scar twice daily for 16 weeks. The lesion will be cleansed with soap and water and dried thoroughly. The medication will be applied with a brush and allow it to dry for one minute before contact with clothing. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Onion extract gel | Drug | Onion extract gel is applied and massaged into the selected scar 3 to 4 times daily according to product instructions for 16 weeks. |
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| Cetearyl alcohol lotion | Drug | Placebo is cetearyl alcohol lotion with no steroids, silicone, vitamin E, or onion extract and will be applied 2 times a day to the lesion. |
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| Assessed at Baseline visit (week 0) and week 16 |
| Change in Lesion Induration | Blinded investigator assessed the scar induration. Measured with a ruler at deepest point. | Assessed at Baseline visit (week 0) and week 16 |
| Change in Lesion Erythema | Blinded investigator assessed the scar erythema. Measured with a visual analog scale (VAS), ranging from 0-100 (0=best and 100=worst). | Assessed at Baseline visit (week 0) and week 16 |
| Change in Lesion Pigmentary Alteration | Blinded investigator assessed the scar pigmentation alteration using a visual analog scale (VAS), ranging from 0-100 (0=best and 100=worst). | Assessed at Baseline visit (week 0) and week 16 |
| Change in Lesion Cosmetic Appearance | Blinded investigator assessed the scar cosmetic appearance using a visual analog scale (VAS), ranging from 0-100 (0=best and 100=worst). | Assessed at Baseline visit (week 0) and week 16 |
| Change in Lesion Cosmetic Appearance | Subjects assessed the scar cosmetic appearance with a visual analog scale (VAS), ranging from 0-100 (0=best and 100=worst). | Assessed at Baseline visit (week 0) and week 16 |
| 12032371 | Background | Musgrave MA, Umraw N, Fish JS, Gomez M, Cartotto RC. The effect of silicone gel sheets on perfusion of hypertrophic burn scars. J Burn Care Rehabil. 2002 May-Jun;23(3):208-14. doi: 10.1097/00004630-200205000-00010. |
| 8874525 | Background | Phillips TJ, Gerstein AD, Lordan V. A randomized controlled trial of hydrocolloid dressing in the treatment of hypertrophic scars and keloids. Dermatol Surg. 1996 Sep;22(9):775-8. doi: 10.1111/j.1524-4725.1996.tb00728.x. |
| Background | Eisen D. A pilot study to evaluate the efficacy of scarguard in the prevention of scars. Internet J Dermatol. 2004;5. |
| 12753606 | Background | Gilman TH. Silicone sheet for treatment and prevention of hypertrophic scar: a new proposal for the mechanism of efficacy. Wound Repair Regen. 2003 May-Jun;11(3):235-6. doi: 10.1046/j.1524-475x.2003.11313.x. No abstract available. |
| 10417579 | Background | Jackson BA, Shelton AJ. Pilot study evaluating topical onion extract as treatment for postsurgical scars. Dermatol Surg. 1999 Apr;25(4):267-9. doi: 10.1046/j.1524-4725.1999.08240.x. |
| 16442038 | Background | Chung VQ, Kelley L, Marra D, Jiang SB. Onion extract gel versus petrolatum emollient on new surgical scars: prospective double-blinded study. Dermatol Surg. 2006 Feb;32(2):193-7. doi: 10.1111/j.1524-4725.2006.32045.x. |
| FG001 | Onion Extract Gel (OE) | Onion extract gel Onion extract gel: Onion extract gel is applied and massaged into the selected scar 3 to 4 times daily according to product instructions for 16 weeks. |
| FG002 | Cetearyl Alcohol Lotion (Placebo) | Cetearyl alcohol lotion Cetearyl alcohol lotion: Placebo is cetearyl alcohol lotion with no steroids, silicone, vitamin E, or onion extract and will be applied 2 times a day to the lesion. |
| COMPLETED |
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| NOT COMPLETED |
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Baseline characteristics are available for the 15 participants that completed the week 16 visit.
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| ID | Title | Description |
|---|---|---|
| BG000 | 0.5% Hydrocortisone, Silicone, Vitamin E Lotion (HSE ) | 0.5% hydrocortisone, silicone, vitamin E lotion 0.5% hydrocortisone, silicone, vitamin E lotion: 0.5% hydrocortisone, silicone, vitamin E lotion will be applied topically to cover the selected scar twice daily for 16 weeks. The lesion will be cleansed with soap and water and dried thoroughly. The medication will be applied with a brush and allow it to dry for one minute before contact with clothing. |
| BG001 | Onion Extract Gel (OE) | Onion extract gel Onion extract gel: Onion extract gel is applied and massaged into the selected scar 3 to 4 times daily according to product instructions for 16 weeks. |
| BG002 | Cetearyl Alcohol Lotion (Placebo) | Cetearyl alcohol lotion Cetearyl alcohol lotion: Placebo is cetearyl alcohol lotion with no steroids, silicone, vitamin E, or onion extract and will be applied 2 times a day to the lesion. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Lesion Volume | Blinded investigator assessed the scar volume by using an alginate impression. | Data only available for participants that completed week 16 visit. | Posted | Mean | Standard Deviation | Percent Change | Assessed at Baseline visit (week 0) and week 16 |
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| Secondary | Change in Lesion Length | Blinded investigator assessed the scar length. Measured with ruler, from scar tip to tip. | Data only available for participants that completed week 16 visit. | Posted | Mean | Standard Deviation | Percent change | Assessed at Baseline visit (week 0) and week 16 |
| |||||||||||||||||||||||||||||||||
| Secondary | Change in Lesion Width | Blinded investigator assessed the scar width. Measured with a ruler at the visually largest width. | Data only available for participants that completed week 16 visit. | Posted | Mean | Standard Deviation | Percent change | Assessed at Baseline visit (week 0) and week 16 |
| |||||||||||||||||||||||||||||||||
| Secondary | Change in Lesion Induration | Blinded investigator assessed the scar induration. Measured with a ruler at deepest point. | Data only available for participants that completed week 16 visit. | Posted | Mean | Standard Deviation | Percent change | Assessed at Baseline visit (week 0) and week 16 |
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| Secondary | Change in Lesion Erythema | Blinded investigator assessed the scar erythema. Measured with a visual analog scale (VAS), ranging from 0-100 (0=best and 100=worst). | Data only available for participants that completed week 16 visit. | Posted | Mean | Standard Deviation | Percent change | Assessed at Baseline visit (week 0) and week 16 |
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| Secondary | Change in Lesion Pigmentary Alteration | Blinded investigator assessed the scar pigmentation alteration using a visual analog scale (VAS), ranging from 0-100 (0=best and 100=worst). | Data only available for participants that completed week 16 visit. | Posted | Mean | Standard Deviation | Percent change | Assessed at Baseline visit (week 0) and week 16 |
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| Secondary | Change in Lesion Cosmetic Appearance | Blinded investigator assessed the scar cosmetic appearance using a visual analog scale (VAS), ranging from 0-100 (0=best and 100=worst). | Data only available for participants that completed week 16 visit. | Posted | Mean | Standard Deviation | Percent change | Assessed at Baseline visit (week 0) and week 16 |
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| Secondary | Change in Lesion Cosmetic Appearance | Subjects assessed the scar cosmetic appearance with a visual analog scale (VAS), ranging from 0-100 (0=best and 100=worst). | Data only available for participants that completed week 16 visit. | Posted | Mean | Standard Deviation | Percent change | Assessed at Baseline visit (week 0) and week 16 |
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Week 16
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 0.5% Hydrocortisone, Silicone, Vitamin E Lotion (HSE ) | 0.5% hydrocortisone, silicone, vitamin E lotion 0.5% hydrocortisone, silicone, vitamin E lotion: 0.5% hydrocortisone, silicone, vitamin E lotion will be applied topically to cover the selected scar twice daily for 16 weeks. The lesion will be cleansed with soap and water and dried thoroughly. The medication will be applied with a brush and allow it to dry for one minute before contact with clothing. | 0 | 10 | 0 | 10 | 0 | 10 |
| EG001 | Onion Extract Gel (OE) | Onion extract gel Onion extract gel: Onion extract gel is applied and massaged into the selected scar 3 to 4 times daily according to product instructions for 16 weeks. | 0 | 10 | 0 | 10 | 1 | 10 |
| EG002 | Cetearyl Alcohol Lotion (Placebo) | Cetearyl alcohol lotion Cetearyl alcohol lotion: Placebo is cetearyl alcohol lotion with no steroids, silicone, vitamin E, or onion extract and will be applied 2 times a day to the lesion. | 0 | 10 | 0 | 10 | 0 | 10 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acneiform-like eruption | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Kirsner | University of Miami | 305-243-4472 | RKirsner@med.miami.edu |
| ID | Term |
|---|---|
| D007627 | Keloid |
| D017439 | Cicatrix, Hypertrophic |
| ID | Term |
|---|---|
| D003095 | Collagen Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002921 | Cicatrix |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D006854 | Hydrocortisone |
| D012828 | Silicones |
| D000431 | Ethanol |
| C011189 | cetyl alcohol, propylene glycol, sodium lauryl sulfate non-lipid cleansing lotion |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D015062 | 11-Hydroxycorticosteroids |
| D006889 | Hydroxycorticosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D015065 | 17-Hydroxycorticosteroids |
| D012833 | Siloxanes |
| D017646 | Organosilicon Compounds |
| D009930 | Organic Chemicals |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D000438 | Alcohols |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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