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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00754247
Recruitment Status : Completed
First Posted : September 17, 2008
Results First Posted : July 10, 2019
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Robert S. Kirsner, University of Miami

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Conditions Keloid
Hypertrophic Scar
Cicatrix, Hypertrophic
Interventions Drug: 0.5% hydrocortisone, silicone, vitamin E lotion
Drug: Onion extract gel
Drug: Cetearyl alcohol lotion
Enrollment 30
Recruitment Details

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.

Pre-assignment Details  
Arm/Group Title 0.5% Hydrocortisone, Silicone, Vitamin E Lotion (HSE ) Onion Extract Gel (OE) Cetearyl Alcohol Lotion (Placebo)
Hide Arm/Group Description

0.5% hydrocortisone, silicone, vitamin E lotion

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.

Onion extract gel

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.

Cetearyl alcohol lotion

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.

Period Title: Overall Study
Started 10 10 10
Completed 5 5 5
Not Completed 5 5 5
Arm/Group Title 0.5% Hydrocortisone, Silicone, Vitamin E Lotion (HSE ) Onion Extract Gel (OE) Cetearyl Alcohol Lotion (Placebo) Total
Hide Arm/Group Description

0.5% hydrocortisone, silicone, vitamin E lotion

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.

Onion extract gel

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.

Cetearyl alcohol lotion

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.

Total of all reporting groups
Overall Number of Baseline Participants 5 5 5 15
Hide Baseline Analysis Population Description
Baseline characteristics are available for the 15 participants that completed the week 16 visit.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 5 participants 15 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
 100.0%
5
 100.0%
5
 100.0%
15
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 5 participants 15 participants
Female
4
  80.0%
3
  60.0%
3
  60.0%
10
  66.7%
Male
1
  20.0%
2
  40.0%
2
  40.0%
5
  33.3%
1.Primary Outcome
Title Change in Lesion Volume
Hide Description Blinded investigator assessed the scar volume by using an alginate impression.
Time Frame Assessed at Baseline visit (week 0) and week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Data only available for participants that completed week 16 visit.
Arm/Group Title 0.5% Hydrocortisone, Silicone, Vitamin E Lotion (HSE ) Onion Extract Gel (OE) Cetearyl Alcohol Lotion (Placebo)
Hide Arm/Group Description:

0.5% hydrocortisone, silicone, vitamin E lotion

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.

Onion extract gel

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.

Cetearyl alcohol lotion

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.

Overall Number of Participants Analyzed 5 5 5
Mean (Standard Deviation)
Unit of Measure: Percent Change
40 [1]   (NA) 42 [1]   (NA) 32 [1]   (NA)
[1]
Sincere efforts were made to obtain the data from the original PI that left the organization, however, no raw data is available for this outcome. The mean data is available in publication, but the SD was not reported.
2.Secondary Outcome
Title Change in Lesion Length
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Data only available for participants that completed week 16 visit.
Arm/Group Title 0.5% Hydrocortisone, Silicone, Vitamin E Lotion (HSE ) Onion Extract Gel (OE) Cetearyl Alcohol Lotion (Placebo)
Hide Arm/Group Description:

0.5% hydrocortisone, silicone, vitamin E lotion

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.

Onion extract gel

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.

Cetearyl alcohol lotion

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.

Overall Number of Participants Analyzed 5 5 5
Mean (Standard Deviation)
Unit of Measure: Percent change
12 [1]   (NA) 13 [1]   (NA) 3 [1]   (NA)
[1]
Sincere efforts were made to obtain the data from the original PI that left the organization, however, no raw data is available for this outcome. The mean data is available in publication, but the SD was not reported.
3.Secondary Outcome
Title Change in Lesion Width
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Data only available for participants that completed week 16 visit.
Arm/Group Title 0.5% Hydrocortisone, Silicone, Vitamin E Lotion (HSE ) Onion Extract Gel (OE) Cetearyl Alcohol Lotion (Placebo)
Hide Arm/Group Description:

0.5% hydrocortisone, silicone, vitamin E lotion

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.

Onion extract gel

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.

Cetearyl alcohol lotion

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.

Overall Number of Participants Analyzed 5 5 5
Mean (Standard Deviation)
Unit of Measure: Percent change
0 [1]   (NA) 16 [1]   (NA) 5 [1]   (NA)
[1]
Sincere efforts were made to obtain the data from the original PI that left the organization, however, no raw data is available for this outcome. The mean data is available in publication, but the SD was not reported.
4.Secondary Outcome
Title Change in Lesion Induration
Hide Description Blinded investigator assessed the scar induration. Measured with a ruler at deepest point.
Time Frame Assessed at Baseline visit (week 0) and week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Data only available for participants that completed week 16 visit.
Arm/Group Title 0.5% Hydrocortisone, Silicone, Vitamin E Lotion (HSE ) Onion Extract Gel (OE) Cetearyl Alcohol Lotion (Placebo)
Hide Arm/Group Description:

0.5% hydrocortisone, silicone, vitamin E lotion

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.

Onion extract gel

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.

Cetearyl alcohol lotion

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.

Overall Number of Participants Analyzed 5 5 5
Mean (Standard Deviation)
Unit of Measure: Percent change
68 [1]   (NA) 50 [1]   (NA) 2 [1]   (NA)
[1]
Sincere efforts were made to obtain the data from the original PI that left the organization, however, no raw data is available for this outcome. The mean data is available in publication, but the SD was not reported.
5.Secondary Outcome
Title Change in Lesion Erythema
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Data only available for participants that completed week 16 visit.
Arm/Group Title 0.5% Hydrocortisone, Silicone, Vitamin E Lotion (HSE ) Onion Extract Gel (OE) Cetearyl Alcohol Lotion (Placebo)
Hide Arm/Group Description:

0.5% hydrocortisone, silicone, vitamin E lotion

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.

Onion extract gel

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.

Cetearyl alcohol lotion

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.

Overall Number of Participants Analyzed 5 5 5
Mean (Standard Deviation)
Unit of Measure: Percent change
72 [1]   (NA) 8 [1]   (NA) 1 [1]   (NA)
[1]
Sincere efforts were made to obtain the data from the original PI that left the organization, however, no raw data is available for this outcome. The mean data is available in publication, but the SD was not reported.
6.Secondary Outcome
Title Change in Lesion Pigmentary Alteration
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Data only available for participants that completed week 16 visit.
Arm/Group Title 0.5% Hydrocortisone, Silicone, Vitamin E Lotion (HSE ) Onion Extract Gel (OE) Cetearyl Alcohol Lotion (Placebo)
Hide Arm/Group Description:

0.5% hydrocortisone, silicone, vitamin E lotion

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.

Onion extract gel

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.

Cetearyl alcohol lotion

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.

Overall Number of Participants Analyzed 5 5 5
Mean (Standard Deviation)
Unit of Measure: Percent change
61 [1]   (NA) 30 [1]   (NA) 0 [1]   (NA)
[1]
Sincere efforts were made to obtain the data from the original PI that left the organization, however, no raw data is available for this outcome. The mean data is available in publication, but the SD was not reported.
7.Secondary Outcome
Title Change in Lesion Cosmetic Appearance
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Data only available for participants that completed week 16 visit.
Arm/Group Title 0.5% Hydrocortisone, Silicone, Vitamin E Lotion (HSE ) Onion Extract Gel (OE) Cetearyl Alcohol Lotion (Placebo)
Hide Arm/Group Description:

0.5% hydrocortisone, silicone, vitamin E lotion

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.

Onion extract gel

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.

Cetearyl alcohol lotion

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.

Overall Number of Participants Analyzed 5 5 5
Mean (Standard Deviation)
Unit of Measure: Percent change
68 [1]   (NA) 25 [1]   (NA) 15 [1]   (NA)
[1]
Sincere efforts were made to obtain the data from the original PI that left the organization, however, no raw data is available for this outcome. The mean data is available in publication, but the SD was not reported.
8.Secondary Outcome
Title Change in Lesion Cosmetic Appearance
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Data only available for participants that completed week 16 visit.
Arm/Group Title 0.5% Hydrocortisone, Silicone, Vitamin E Lotion (HSE ) Onion Extract Gel (OE) Cetearyl Alcohol Lotion (Placebo)
Hide Arm/Group Description:

0.5% hydrocortisone, silicone, vitamin E lotion

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.

Onion extract gel

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.

Cetearyl alcohol lotion

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.

Overall Number of Participants Analyzed 5 5 5
Mean (Standard Deviation)
Unit of Measure: Percent change
48 [1]   (NA) 20 [1]   (NA) 58 [1]   (NA)
[1]
Sincere efforts were made to obtain the data from the original PI that left the organization, however, no raw data is available for this outcome. The mean data is available in publication, but the SD was not reported.
Time Frame Week 16
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 0.5% Hydrocortisone, Silicone, Vitamin E Lotion (HSE ) Onion Extract Gel (OE) Cetearyl Alcohol Lotion (Placebo)
Hide Arm/Group Description

0.5% hydrocortisone, silicone, vitamin E lotion

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.

Onion extract gel

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.

Cetearyl alcohol lotion

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.

All-Cause Mortality
0.5% Hydrocortisone, Silicone, Vitamin E Lotion (HSE ) Onion Extract Gel (OE) Cetearyl Alcohol Lotion (Placebo)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%)   0/10 (0.00%) 
Hide Serious Adverse Events
0.5% Hydrocortisone, Silicone, Vitamin E Lotion (HSE ) Onion Extract Gel (OE) Cetearyl Alcohol Lotion (Placebo)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%)   0/10 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
0.5% Hydrocortisone, Silicone, Vitamin E Lotion (HSE ) Onion Extract Gel (OE) Cetearyl Alcohol Lotion (Placebo)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   1/10 (10.00%)   0/10 (0.00%) 
Skin and subcutaneous tissue disorders       
Acneiform-like eruption   0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Robert Kirsner
Organization: University of Miami
Phone: 305-243-4472
EMail: RKirsner@med.miami.edu
Layout table for additonal information
Responsible Party: Robert S. Kirsner, University of Miami
ClinicalTrials.gov Identifier: NCT00754247    
Other Study ID Numbers: 20060131
First Submitted: September 15, 2008
First Posted: September 17, 2008
Results First Submitted: February 18, 2019
Results First Posted: July 10, 2019
Last Update Posted: July 10, 2019