A Phase 4 interventional study of 0.5% hydrocortisone, silicone, vitamin E lotion and Onion extract gel in Keloid, Hypertrophic Scar and Cicatrix, Hypertrophic, sponsored by University of Miami. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-10.
Sponsored by University of Miami · Phase 4, Interventional, and Treatment
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
123 studies on the registry are indexed under Keloid; 23 are open to participants now.
This study's enrollment of 30 is close to the median of 30 across 97 interventional studies indexed under Keloid.
Browse Keloid studies →University of Miami is the lead sponsor of 821 studies on the registry; 162 are open to participants now.
Of its 111 completed or terminated interventional studies of FDA-regulated products, 93 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
0.5% hydrocortisone, silicone, vitamin E lotion
Drug: 0.5% hydrocortisone, silicone, vitamin E lotion
Onion extract gel
Drug: Onion extract gel
Cetearyl alcohol lotion
Drug: Cetearyl alcohol 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.
Also known as: Scarguard
Onion extract gel is applied and massaged into the selected scar 3 to 4 times daily according to product instructions for 16 weeks.
Also known as: Mederma
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.
Also known as: Cetaphil lotion
Change in Lesion Volume
Blinded investigator assessed the scar volume by using an alginate impression.
Time frame: Assessed at Baseline visit (week 0) and week 16
Change in Lesion Length
Blinded investigator assessed the scar length. Measured with ruler, from scar tip to tip.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Assessed at Baseline visit (week 0) and week 16
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.
| Milestone | 0.5% Hydrocortisone, Silicone, Vitamin E Lotion (HSE ) | Onion Extract Gel (OE) | Cetearyl Alcohol Lotion (Placebo) |
|---|---|---|---|
| Started | 10 | 10 | 10 |
| Completed | 5 | 5 | 5 |
| Not completed | 5 | 5 | 5 |
Blinded investigator assessed the scar volume by using an alginate impression.
| Percent Change | 0.5% Hydrocortisone, Silicone, Vitamin E Lotion (HSE ) | Onion Extract Gel (OE) | Cetearyl Alcohol Lotion (Placebo) |
|---|---|---|---|
| Change in Lesion Volume | 40 ± NA | 42 ± NA | 32 ± NA |
Blinded investigator assessed the scar length. Measured with ruler, from scar tip to tip.
| Percent change | 0.5% Hydrocortisone, Silicone, Vitamin E Lotion (HSE ) | Onion Extract Gel (OE) | Cetearyl Alcohol Lotion (Placebo) |
|---|---|---|---|
| Change in Lesion Length | 12 ± NA | 13 ± NA | 3 ± NA |
Blinded investigator assessed the scar width. Measured with a ruler at the visually largest width.
| Percent change | 0.5% Hydrocortisone, Silicone, Vitamin E Lotion (HSE ) | Onion Extract Gel (OE) | Cetearyl Alcohol Lotion (Placebo) |
|---|---|---|---|
| Change in Lesion Width | 0 ± NA | 16 ± NA | 5 ± NA |
Blinded investigator assessed the scar induration. Measured with a ruler at deepest point.
| Percent change | 0.5% Hydrocortisone, Silicone, Vitamin E Lotion (HSE ) | Onion Extract Gel (OE) | Cetearyl Alcohol Lotion (Placebo) |
|---|---|---|---|
| Change in Lesion Induration | 68 ± NA | 50 ± NA | 2 ± NA |
Blinded investigator assessed the scar erythema. Measured with a visual analog scale (VAS), ranging from 0-100 (0=best and 100=worst).
| Percent change | 0.5% Hydrocortisone, Silicone, Vitamin E Lotion (HSE ) | Onion Extract Gel (OE) | Cetearyl Alcohol Lotion (Placebo) |
|---|---|---|---|
| Change in Lesion Erythema | 72 ± NA | 8 ± NA | 1 ± NA |
Blinded investigator assessed the scar pigmentation alteration using a visual analog scale (VAS), ranging from 0-100 (0=best and 100=worst).
| Percent change | 0.5% Hydrocortisone, Silicone, Vitamin E Lotion (HSE ) | Onion Extract Gel (OE) | Cetearyl Alcohol Lotion (Placebo) |
|---|---|---|---|
| Change in Lesion Pigmentary Alteration | 61 ± NA | 30 ± NA | 0 ± NA |
Blinded investigator assessed the scar cosmetic appearance using a visual analog scale (VAS), ranging from 0-100 (0=best and 100=worst).
| Percent change | 0.5% Hydrocortisone, Silicone, Vitamin E Lotion (HSE ) | Onion Extract Gel (OE) | Cetearyl Alcohol Lotion (Placebo) |
|---|---|---|---|
| Change in Lesion Cosmetic Appearance | 68 ± NA | 25 ± NA | 15 ± NA |
Subjects assessed the scar cosmetic appearance with a visual analog scale (VAS), ranging from 0-100 (0=best and 100=worst).
| Percent change | 0.5% Hydrocortisone, Silicone, Vitamin E Lotion (HSE ) | Onion Extract Gel (OE) | Cetearyl Alcohol Lotion (Placebo) |
|---|---|---|---|
| Change in Lesion Cosmetic Appearance | 48 ± NA | 20 ± NA | 58 ± NA |
Collected over Week 16. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 0.5% Hydrocortisone, Silicone, Vitamin E Lotion (HSE ) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Onion Extract Gel (OE) | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) |
| Cetearyl Alcohol Lotion (Placebo) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Event | 0.5% Hydrocortisone, Silicone, Vitamin E Lotion (HSE ) | Onion Extract Gel (OE) | Cetearyl Alcohol Lotion (Placebo) |
|---|---|---|---|
| Acneiform-like eruptionSkin and subcutaneous tissue disorders | 0/10 | 1/10 | 0/10 |
Baseline characteristics are available for the 15 participants that completed the week 16 visit.
| Age, Categorical(Participants) | 0.5% Hydrocortisone, Silicone, Vitamin E Lotion (HSE ) | Onion Extract Gel (OE) | Cetearyl Alcohol Lotion (Placebo) | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 5 | 5 | 5 | 15 |
| >=65 years | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | 0.5% Hydrocortisone, Silicone, Vitamin E Lotion (HSE ) | Onion Extract Gel (OE) | Cetearyl Alcohol Lotion (Placebo) | Total |
|---|---|---|---|---|
| Female | 4 | 3 | 3 | 10 |
| Male | 1 | 2 | 2 | 5 |
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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