A Randomized Comparative Study Evaluating the Tolerability and Efficacy of Two Topical Therapies for the Treatment of Keloids and Hypertrophic Scars

Overview[ - collapse ][ - ]

Purpose 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.
ConditionKeloid
Hypertrophic Scar
Cicatrix, Hypertrophic
InterventionDrug: 0.5% hydrocortisone, silicone, vitamin E lotion
Drug: Onion extract gel
Drug: Cetearyl alcohol lotion
PhasePhase 4
SponsorUniversity of Miami
Responsible PartyUniversity of Miami
ClinicalTrials.gov IdentifierNCT00754247
First ReceivedSeptember 15, 2008
Last UpdatedOctober 18, 2010
Last verifiedSeptember 2008

Tracking Information[ + expand ][ + ]

First Received DateSeptember 15, 2008
Last Updated DateOctober 18, 2010
Start DateMarch 2006
Estimated Primary Completion DateFebruary 2008
Current Primary Outcome MeasuresAssessment of target scar by investigator (size, color, firmness, symptoms such as tenderness, pain, and itching) [Time Frame: Baseline visit (week 0) and weeks 4, 8, 12, 16] [Designated as safety issue: No]
Current Secondary Outcome Measures
  • Volume changes [Time Frame: Baseline visit (week 0) and weeks 4, 8, 12, 16] [Designated as safety issue: No]
  • Color changes [Time Frame: Baseline visit (week 0) and weeks 4, 8, 12, 16] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief TitleA Randomized Comparative Study Evaluating the Tolerability and Efficacy of Two Topical Therapies for the Treatment of Keloids and Hypertrophic Scars
Official TitleA Prospective, Randomized, Investigator-blinded, Placebo-controlled, Comparative Study Evaluating the Tolerability and Efficacy of Two Topical Therapies for the Treatment of Keloids and Hypertrophic Scars
Brief Summary
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.
Detailed Description
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
Study TypeInterventional
Study PhasePhase 4
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Condition
  • Keloid
  • Hypertrophic Scar
  • Cicatrix, Hypertrophic
InterventionDrug: 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.
Other Names:
ScarguardDrug: 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.
Other Names:
MedermaDrug: 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.
Other Names:
Cetaphil lotion
Study Arm (s)
  • Experimental: Regimen A
    0.5% hydrocortisone, silicone, vitamin E lotion
  • Experimental: Regimen B
    Onion extract gel
  • Placebo Comparator: Regimen C
    Cetearyl alcohol lotion

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment30
Estimated Completion DateFebruary 2008
Estimated Primary Completion DateFebruary 2008
Eligibility Criteria
Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to be eligible for enrollment
into the study:

1. Male or female, at least 18 years old in good general health, that have a
hypertrophic and keloid scar. The length of the scar should be between 1-4 cm.
Individuals who are willing and able to follow the requirements for study
participation

2. The investigator believes that the scar could benefit from the study medication.

Exclusion Criteria:

Subjects who meet any of the following criteria should be excluded from the study:

1. Individuals with target scar that is not amenable to the randomized treatment

2. Individuals who are planning pregnancy, or pregnant as determined by urine pregnancy
test during the duration of the study, or breast-feeding an infant

3. Individuals with uncontrolled diabetes or autoimmune disorders

4. Individuals who have received scar treatment within one month of the first day of
study treatment

5. Individuals who plan to receive scar treatment(s) other than study treatment during
the trial

6. Individuals with a known sensitivity to any ingredients in the test products

7. Individuals with any skin conditions or taking any medications that may interfere
with the study medication.
GenderBoth
Ages18 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
ContactsNot Provided
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT00754247
Other Study ID Numbers20060131
Has Data Monitoring CommitteeNo
Information Provided ByUniversity of Miami
Study SponsorUniversity of Miami
CollaboratorsNot Provided
Investigators Principal Investigator: Brian Berman, M.D., Ph.D University of Miami, Department of Dermatology and Cutaneous Surgery
Verification DateSeptember 2008

Locations[ + expand ][ + ]

University of Miami Skin Research Group Office
Miami, Florida, United States, 33136