KeloidPhase 4NCT00754247

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

A Phase 4 study testing 0.5% hydrocortisone, silicone, vitamin E lotion, Onion extract gel and Cetearyl alcohol lotion in people with Keloid and Hypertrophic Scar, run by University of Miami at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Keloid, Hypertrophic Scar, Cicatrix, Hypertrophic
What is being tested?: 0.5% hydrocortisone, silicone, vitamin E lotion, Onion extract gel and Cetearyl alcohol lotion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 30 participants
Where: 1 siteUnited States
Study dates: Mar 2006to Feb 2008
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

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

Other trials in United States

About this study

Official title: A 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

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.

Read the 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

Volume B. Linear dimensions

Investigator's Assessments w/ Visual Analog Scale (VAS):

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:

Cosmetic assessment H. Pain I. Tenderness J. Pruritus (itching) K. Patient satisfaction
Digital photographs

Conditions: Keloid, Hypertrophic Scar, Cicatrix, Hypertrophic
Being tested: 0.5% hydrocortisone, silicone, vitamin E lotion, Onion extract gel, Cetearyl alcohol lotion
Keywords: Keloid, Hypertrophic scar, Hydrocortisone, silicone, vitamin E lotion, HSE, Onion extract gel, OE, Cetearyl alcohol lotion, CEA
Medical subject headings: Keloid, Cicatrix, Hypertrophic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

0.5% hydrocortisone, silicone, vitamin E lotionDrug
Also called Scarguard
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 gelDrug
Also called Mederma
Onion extract gel is applied and massaged into the selected scar 3 to 4 times daily according to product instructions for 16 weeks.
Cetearyl alcohol lotionDrug
Also called Cetaphil 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.

Study groups in NCT00754247
Study group	Role	What they receive
Regimen A	Experimental	0.5% hydrocortisone, silicone, vitamin E lotion Receives: Drug: 0.5% hydrocortisone, silicone, vitamin E lotion
Regimen B	Experimental	Onion extract gel Receives: Drug: Onion extract gel
Regimen C	Placebo comparator	Cetearyl alcohol lotion Receives: Drug: Cetearyl alcohol lotion

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Lesion Volume
Blinded investigator assessed the scar volume by using an alginate impression.
Measured: Assessed at Baseline visit (week 0) and week 16

Secondary outcomes (7)

Change in Lesion Length
Blinded investigator assessed the scar length. Measured with ruler, from scar tip to tip.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Assessed at Baseline visit (week 0) and week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2006Feb 2008

First posted17 Sep 2008 (estimated)
Study startMar 2006
Primary completionFeb 2008
Study completionFeb 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (8)Papers the sponsor has linked to this study.
Other trials for KeloidStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00754247
Sponsor's protocol ID: 20060131
Status last verified: Jun 2019
First submitted: 15 Sep 2008
Last updated: 10 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Augusti KT. Therapeutic values of onion (Allium cepa L.) and garlic (Allium sativum L.). Indian J Exp Biol. 1996 Jul;34(7):634-40.
PubMed 8979497
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.
PubMed 12087249
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.
PubMed 12032371
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.
PubMed 8874525
Eisen D. A pilot study to evaluate the efficacy of scarguard in the prevention of scars. Internet J Dermatol. 2004;5.
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.
PubMed 12753606
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.
PubMed 10417579
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.
PubMed 16442038

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 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
ClinicalTrials.gov ID: NCT00754247
Acronym / sponsor ID: 20060131
Conditions: Keloid, Hypertrophic Scar, Cicatrix, Hypertrophic
Keywords: Keloid, Hypertrophic scar, Hydrocortisone, silicone, vitamin E lotion, HSE, Onion extract gel, OE, Cetearyl alcohol lotion, CEA
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: University of MiamiUniversity, hospital or other
Study start: Mar 2006
Primary completion: Feb 2008 (actual)
Study completion: Feb 2008 (actual)
First posted: 17 Sep 2008 (estimated)
Results: Posted 10 Jul 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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:

Week 4, 8, 12, and 16 Visit:

Methods of Study Lesion Assessment

Volume B. Linear dimensions

Investigator's Assessments w/ Visual Analog Scale (VAS):

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:

Cosmetic assessment H. Pain I. Tenderness J. Pruritus (itching) K. Patient satisfaction
Digital photographs

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 3

Arm	Type	Receives
Regimen A	Experimental	Drug: 0.5% hydrocortisone, silicone, vitamin E lotion0.5% hydrocortisone, silicone, vitamin E lotion
Regimen B	Experimental	Drug: Onion extract gelOnion extract gel
Regimen C	Placebo comparator	Drug: Cetearyl alcohol lotionCetearyl alcohol lotion

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
0.5% hydrocortisone, silicone, vitamin E lotionAlso: Scarguard0.5% 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.	Drug	Regimen A
Onion extract gelAlso: MedermaOnion extract gel is applied and massaged into the selected scar 3 to 4 times daily according to product instructions for 16 weeks.	Drug	Regimen B
Cetearyl alcohol lotionAlso: Cetaphil lotionPlacebo is cetearyl alcohol lotion with no steroids, silicone, vitamin E, or onion extract and will be applied 2 times a day to the lesion.	Drug	Regimen C

Primary outcome

Change in Lesion Volume
Time frame: Assessed at Baseline visit (week 0) and week 16
Blinded investigator assessed the scar volume by using an alginate impression.

7 secondary outcomes

Change in Lesion Length
Time frame: Assessed at Baseline visit (week 0) and week 16
Change in Lesion Width
Time frame: Assessed at Baseline visit (week 0) and week 16
Change in Lesion Induration
Time frame: Assessed at Baseline visit (week 0) and week 16
Change in Lesion Erythema
Time frame: Assessed at Baseline visit (week 0) and week 16
Change in Lesion Pigmentary Alteration
Time frame: Assessed at Baseline visit (week 0) and week 16
Change in Lesion Cosmetic Appearance
Time frame: Assessed at Baseline visit (week 0) and week 16
Change in Lesion Cosmetic Appearance
Time frame: Assessed at Baseline visit (week 0) and week 16

Results and safety

Results posted to the registry on 10 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
0.5% Hydrocortisone, Silicone, Vitamin E Lotion (HSE )	10	5
Onion Extract Gel (OE)	10	5
Cetearyl Alcohol Lotion (Placebo)	10	5

Primary outcome: Change in Lesion Volume

Time frame: Assessed at Baseline visit (week 0) and week 16. Mean (Standard Deviation). Unit: Percent Change

Measure	0.5% Hydrocortisone, Silicone, Vitamin E Lotion (HSE ) n = 5	Onion Extract Gel (OE) n = 5	Cetearyl Alcohol Lotion (Placebo) n = 5
Value	40 (NA)	42 (NA)	32 (NA)

Population analysed: Data only available for participants that completed week 16 visit.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Week 16. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
0.5% Hydrocortisone, Silicone, Vitamin E Lotion (HSE )	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Onion Extract Gel (OE)	0 of 10 (0%)	1 of 10 (10%)	0 of 10
Cetearyl Alcohol Lotion (Placebo)	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 8979497Augusti KT. Therapeutic values of onion (Allium cepa L.) and garlic (Allium sativum L.). Indian J Exp Biol. 1996 Jul;34(7):634-40.
Background: PubMed 12087249Saulis 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.
Background: PubMed 12032371Musgrave 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.
Background: PubMed 8874525Phillips 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.
BackgroundEisen D. A pilot study to evaluate the efficacy of scarguard in the prevention of scars. Internet J Dermatol. 2004;5.
Background: PubMed 12753606Gilman 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.
Background: PubMed 10417579Jackson 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.
Background: PubMed 16442038Chung 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.
Skin Research Group WebsiteLink provided by the sponsor.

Related trials for Keloid

Active, not recruiting
Transdermal Versus Intralesional Betamethasone for Keloids
Keloid
RecruitingPhase 2
Ritlecitinib in Patients With Keloids or Those Undergoing Keloidectomy
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Brian Berman, M.D., Ph.D principal investigator

University of Miami, Department of Dermatology and Cutaneous Surgery

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Lesion Volume (time frame: Assessed at Baseline visit (week 0) and week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00754247, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2019.