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

NCT00754247 | Completed Phase 4 Results

• 1 other identifier: 20060131
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Keloid; Hypertrophic Scar; Cicatrix, Hypertrophic

Keywords

Keloid; Hypertrophic scar; Hydrocortisone, silicone, vitamin E lotion; HSE; Onion extract gel; OE; Cetearyl alcohol lotion; CEA

Outcome Measures

Primary Outcomes (1)

• Change in Lesion Volume

  Blinded investigator assessed the scar volume by using an alginate impression.

  Assessed at Baseline visit (week 0) and week 16

Secondary Outcomes (7)

• Change in Lesion Length

  Assessed at Baseline visit (week 0) and week 16

• Change in Lesion Width

  Assessed at Baseline visit (week 0) and week 16

• Change in Lesion Induration

  Assessed at Baseline visit (week 0) and week 16

• Change in Lesion Erythema

  Assessed at Baseline visit (week 0) and week 16

• Change in Lesion Pigmentary Alteration

  Assessed at Baseline visit (week 0) and week 16

Study Arms (3)

Regimen A

EXPERIMENTAL

0.5% hydrocortisone, silicone, vitamin E lotion

Drug: 0.5% hydrocortisone, silicone, vitamin E lotion

Regimen B

EXPERIMENTAL

Onion extract gel

Drug: Onion extract gel

Regimen C

PLACEBO COMPARATOR

Cetearyl alcohol lotion

Drug: Cetearyl alcohol lotion

Interventions

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.

Also known as: Scarguard

Regimen A

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.

Also known as: Mederma

Regimen B

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.

Also known as: Cetaphil lotion

Regimen C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Subjects who meet any of the following criteria should be excluded from the study:
• Individuals with target scar that is not amenable to the randomized treatment
• Individuals who are planning pregnancy, or pregnant as determined by urine pregnancy test during the duration of the study, or breast-feeding an infant
• Individuals with uncontrolled diabetes or autoimmune disorders
• Individuals who have received scar treatment within one month of the first day of study treatment
• Individuals who plan to receive scar treatment(s) other than study treatment during the trial
• Individuals with a known sensitivity to any ingredients in the test products
• Individuals with any skin conditions or taking any medications that may interfere with the study medication.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami Skin Research Group Office

Miami, Florida, 33136, United States

Location

Related Publications (8)

• Augusti KT. Therapeutic values of onion (Allium cepa L.) and garlic (Allium sativum L.). Indian J Exp Biol. 1996 Jul;34(7):634-40.

  PMID: 8979497 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.

  PMID: 12087249 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.

  PMID: 12032371 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.

  PMID: 8874525 BACKGROUND

• Eisen D. A pilot study to evaluate the efficacy of scarguard in the prevention of scars. Internet J Dermatol. 2004;5.

  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.

  PMID: 12753606 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.

  PMID: 10417579 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.

  PMID: 16442038 BACKGROUND

Related Links

• Skin Research Group Website

MeSH Terms

Conditions

Keloid; Cicatrix, Hypertrophic

Interventions

Hydrocortisone; Silicones; Ethanol; cetyl alcohol, propylene glycol, sodium lauryl sulfate non-lipid cleansing lotion

Condition Hierarchy (Ancestors)

Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids; Siloxanes; Organosilicon Compounds; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Alcohols

Results Point of Contact

• Title: Dr. Robert Kirsner
• Organization: University of Miami

RKirsner@med.miami.edu

305-243-4472

Study Officials

• Brian Berman, M.D., Ph.D

  University of Miami, Department of Dermatology and Cutaneous Surgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 15, 2008
• First Posted: September 17, 2008
• Study Start: March 1, 2006
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: July 10, 2019
• Results First Posted: July 10, 2019

Record last verified: 2019-06

Locations

US (1)