A Randomized Comparative Study Evaluating the Tolerability and Efficacy of Two Topical Therapies for the Treatment of Keloids and Hypertrophic Scars
Condition: Keloid; Hypertrophic Scar; Cicatrix, Hypertrophic
MeSH terms: Keloid; Cicatrix; Hypertrophy; Cicatrix, Hypertrophic
Intervention: 0.5% hydrocortisone, silicone, vitamin E lotion; Onion extract gel; Cetearyl alcohol lotion
Intervention description: 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.; Onion extract gel is applied and massaged into the selected scar 3 to 4 times daily according to product instructions for 16 weeks.; 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.
Intervention MeSH terms: Vitamin E; Hydrocortisone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Keloid; Hypertrophic scar; Hydrocortisone, silicone, vitamin E lotion; HSE; Onion extract gel; OE; Cetearyl alcohol lotion; CEA

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.
    

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.