Trial Outcomes & Findings for A Randomized Comparative Study Evaluating the Tolerability and Efficacy of Two Topical Therapies for the Treatment of Keloids and Hypertrophic Scars (NCT NCT00754247)
NCT ID: NCT00754247
Last Updated: 2019-07-10
Results Overview
Blinded investigator assessed the scar volume by using an alginate impression.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
30 participants
Primary outcome timeframe
Assessed at Baseline visit (week 0) and week 16
Results posted on
2019-07-10
Participant Flow
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.
Participant milestones
| Measure |
0.5% Hydrocortisone, Silicone, Vitamin E Lotion (HSE )
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 (OE)
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 (Placebo)
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 Study
STARTED
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
5
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Randomized Comparative Study Evaluating the Tolerability and Efficacy of Two Topical Therapies for the Treatment of Keloids and Hypertrophic Scars
Baseline characteristics by cohort
| Measure |
0.5% Hydrocortisone, Silicone, Vitamin E Lotion (HSE )
n=5 Participants
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 (OE)
n=5 Participants
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 (Placebo)
n=5 Participants
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
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Assessed at Baseline visit (week 0) and week 16Population: Data only available for participants that completed week 16 visit.
Blinded investigator assessed the scar volume by using an alginate impression.
Outcome measures
| Measure |
0.5% Hydrocortisone, Silicone, Vitamin E Lotion (HSE )
n=5 Participants
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 (OE)
n=5 Participants
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 (Placebo)
n=5 Participants
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.
|
|---|---|---|---|
|
Change in Lesion Volume
|
40 Percent Change
Standard Deviation NA
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.
|
42 Percent Change
Standard Deviation NA
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.
|
32 Percent Change
Standard Deviation NA
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.
|
SECONDARY outcome
Timeframe: Assessed at Baseline visit (week 0) and week 16Population: Data only available for participants that completed week 16 visit.
Blinded investigator assessed the scar length. Measured with ruler, from scar tip to tip.
Outcome measures
| Measure |
0.5% Hydrocortisone, Silicone, Vitamin E Lotion (HSE )
n=5 Participants
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 (OE)
n=5 Participants
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 (Placebo)
n=5 Participants
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.
|
|---|---|---|---|
|
Change in Lesion Length
|
12 Percent change
Standard Deviation NA
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.
|
13 Percent change
Standard Deviation NA
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 Percent change
Standard Deviation NA
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.
|
SECONDARY outcome
Timeframe: Assessed at Baseline visit (week 0) and week 16Population: Data only available for participants that completed week 16 visit.
Blinded investigator assessed the scar width. Measured with a ruler at the visually largest width.
Outcome measures
| Measure |
0.5% Hydrocortisone, Silicone, Vitamin E Lotion (HSE )
n=5 Participants
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 (OE)
n=5 Participants
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 (Placebo)
n=5 Participants
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.
|
|---|---|---|---|
|
Change in Lesion Width
|
0 Percent change
Standard Deviation NA
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.
|
16 Percent change
Standard Deviation NA
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 Percent change
Standard Deviation NA
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.
|
SECONDARY outcome
Timeframe: Assessed at Baseline visit (week 0) and week 16Population: Data only available for participants that completed week 16 visit.
Blinded investigator assessed the scar induration. Measured with a ruler at deepest point.
Outcome measures
| Measure |
0.5% Hydrocortisone, Silicone, Vitamin E Lotion (HSE )
n=5 Participants
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 (OE)
n=5 Participants
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 (Placebo)
n=5 Participants
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.
|
|---|---|---|---|
|
Change in Lesion Induration
|
68 Percent change
Standard Deviation NA
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.
|
50 Percent change
Standard Deviation NA
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 Percent change
Standard Deviation NA
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.
|
SECONDARY outcome
Timeframe: Assessed at Baseline visit (week 0) and week 16Population: Data only available for participants that completed week 16 visit.
Blinded investigator assessed the scar erythema. Measured with a visual analog scale (VAS), ranging from 0-100 (0=best and 100=worst).
Outcome measures
| Measure |
0.5% Hydrocortisone, Silicone, Vitamin E Lotion (HSE )
n=5 Participants
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 (OE)
n=5 Participants
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 (Placebo)
n=5 Participants
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.
|
|---|---|---|---|
|
Change in Lesion Erythema
|
72 Percent change
Standard Deviation NA
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 Percent change
Standard Deviation NA
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.
|
1 Percent change
Standard Deviation NA
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.
|
SECONDARY outcome
Timeframe: Assessed at Baseline visit (week 0) and week 16Population: Data only available for participants that completed week 16 visit.
Blinded investigator assessed the scar pigmentation alteration using a visual analog scale (VAS), ranging from 0-100 (0=best and 100=worst).
Outcome measures
| Measure |
0.5% Hydrocortisone, Silicone, Vitamin E Lotion (HSE )
n=5 Participants
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 (OE)
n=5 Participants
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 (Placebo)
n=5 Participants
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.
|
|---|---|---|---|
|
Change in Lesion Pigmentary Alteration
|
61 Percent change
Standard Deviation NA
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.
|
30 Percent change
Standard Deviation NA
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.
|
0 Percent change
Standard Deviation NA
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.
|
SECONDARY outcome
Timeframe: Assessed at Baseline visit (week 0) and week 16Population: Data only available for participants that completed week 16 visit.
Blinded investigator assessed the scar cosmetic appearance using a visual analog scale (VAS), ranging from 0-100 (0=best and 100=worst).
Outcome measures
| Measure |
0.5% Hydrocortisone, Silicone, Vitamin E Lotion (HSE )
n=5 Participants
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 (OE)
n=5 Participants
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 (Placebo)
n=5 Participants
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.
|
|---|---|---|---|
|
Change in Lesion Cosmetic Appearance
|
68 Percent change
Standard Deviation NA
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.
|
25 Percent change
Standard Deviation NA
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.
|
15 Percent change
Standard Deviation NA
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.
|
SECONDARY outcome
Timeframe: Assessed at Baseline visit (week 0) and week 16Population: Data only available for participants that completed week 16 visit.
Subjects assessed the scar cosmetic appearance with a visual analog scale (VAS), ranging from 0-100 (0=best and 100=worst).
Outcome measures
| Measure |
0.5% Hydrocortisone, Silicone, Vitamin E Lotion (HSE )
n=5 Participants
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 (OE)
n=5 Participants
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 (Placebo)
n=5 Participants
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.
|
|---|---|---|---|
|
Change in Lesion Cosmetic Appearance
|
48 Percent change
Standard Deviation NA
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.
|
20 Percent change
Standard Deviation NA
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.
|
58 Percent change
Standard Deviation NA
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.
|
Adverse Events
0.5% Hydrocortisone, Silicone, Vitamin E Lotion (HSE )
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Onion Extract Gel (OE)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cetearyl Alcohol Lotion (Placebo)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
0.5% Hydrocortisone, Silicone, Vitamin E Lotion (HSE )
n=10 participants at risk
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 (OE)
n=10 participants at risk
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 (Placebo)
n=10 participants at risk
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.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Acneiform-like eruption
|
0.00%
0/10 • Week 16
|
10.0%
1/10 • Week 16
|
0.00%
0/10 • Week 16
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place