Trial Outcomes & Findings for Skin Camouflage for Women Prisoners With Self-Harm Scarring (NCT NCT02638974)
NCT ID: NCT02638974
Last Updated: 2019-10-18
Results Overview
WEMWBS, Minimum: 14 Maximum: 70. Higher scores represent higher mental wellbeing
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
51 participants
Primary outcome timeframe
6 weeks
Results posted on
2019-10-18
Participant Flow
Participant milestones
| Measure |
Medical Skin Camouflage
This arm will use medical skin camouflage for 6 weeks
Medical Skin Camouflage: Medical skin camouflage is a prescription preparation designed to cover scars and other skin conditions
|
Wait List Control
This arm will receive medical skin camouflage at the end of the study
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
25
|
|
Overall Study
COMPLETED
|
23
|
22
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Participants withdrew from the research
Baseline characteristics by cohort
| Measure |
Medical Skin Camouflage
n=26 Participants
This arm will use medical skin camouflage for 6 weeks
Medical Skin Camouflage: Medical skin camouflage is a prescription preparation designed to cover scars and other skin conditions
|
Wait List Control
n=25 Participants
This arm will receive medical skin camouflage at the end of the study
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31 years
n=23 Participants • Participants withdrew from the research
|
29 years
n=23 Participants • Participants withdrew from the research
|
30 years
n=46 Participants • Participants withdrew from the research
|
|
Sex: Female, Male
Female
|
23 Participants
n=23 Participants • Participants withdrew from the research
|
23 Participants
n=23 Participants • Participants withdrew from the research
|
46 Participants
n=46 Participants • Participants withdrew from the research
|
|
Sex: Female, Male
Male
|
0 Participants
n=23 Participants • Participants withdrew from the research
|
0 Participants
n=23 Participants • Participants withdrew from the research
|
0 Participants
n=46 Participants • Participants withdrew from the research
|
|
Race/Ethnicity, Customized
Ethnicity · White
|
22 Participants
n=23 Participants • Participants withdrew from the research
|
22 Participants
n=23 Participants • Participants withdrew from the research
|
44 Participants
n=46 Participants • Participants withdrew from the research
|
|
Race/Ethnicity, Customized
Ethnicity · Non-white
|
1 Participants
n=23 Participants • Participants withdrew from the research
|
1 Participants
n=23 Participants • Participants withdrew from the research
|
2 Participants
n=46 Participants • Participants withdrew from the research
|
|
Adapted-Dermatology Quality of Life Index
|
12.6957 score on a scale
STANDARD_DEVIATION 3.95928 • n=23 Participants • Participants withdrew from the study so their data was not analysed
|
12.2609 score on a scale
STANDARD_DEVIATION 6.51723 • n=23 Participants • Participants withdrew from the study so their data was not analysed
|
12.4783 score on a scale
STANDARD_DEVIATION 5.33641 • n=46 Participants • Participants withdrew from the study so their data was not analysed
|
|
Beck's Depression Inventory
|
33.6957 score on a scale
STANDARD_DEVIATION 11.39950 • n=23 Participants • Participants withdrew from the research
|
38.9565 score on a scale
STANDARD_DEVIATION 6.99011 • n=23 Participants • Participants withdrew from the research
|
36.3261 score on a scale
STANDARD_DEVIATION 9.72066 • n=46 Participants • Participants withdrew from the research
|
|
Beck's Hopelessness Scale
|
10.0000 score on a scale
STANDARD_DEVIATION 5.86980 • n=23 Participants • Participants withdrew from the research.
|
14.6957 score on a scale
STANDARD_DEVIATION 4.43575 • n=23 Participants • Participants withdrew from the research.
|
12.3478 score on a scale
STANDARD_DEVIATION 5.66556 • n=46 Participants • Participants withdrew from the research.
|
|
Beck's Scale for Suicide Ideation
|
6.2273 score on a scale
STANDARD_DEVIATION 7.75783 • n=22 Participants • Participants withdrew from the research or decline to answer this scale
|
8.8636 score on a scale
STANDARD_DEVIATION 8.66463 • n=22 Participants • Participants withdrew from the research or decline to answer this scale
|
7.5455 score on a scale
STANDARD_DEVIATION 8.23621 • n=44 Participants • Participants withdrew from the research or decline to answer this scale
|
|
Warwick-Edinburgh Mental Wellbeing Scale
|
36.0435 score on a scale
STANDARD_DEVIATION 11.17008 • n=23 Participants • Participants withdrew from the research.
|
30.2609 score on a scale
STANDARD_DEVIATION 9.12647 • n=23 Participants • Participants withdrew from the research.
|
33.1522 score on a scale
STANDARD_DEVIATION 10.50072 • n=46 Participants • Participants withdrew from the research.
|
|
Rosenberg Self Esteem Scale
|
11.6522 score on a scale
STANDARD_DEVIATION 4.68662 • n=23 Participants • Participants withdrew from the research
|
9.6087 score on a scale
STANDARD_DEVIATION 3.38095 • n=23 Participants • Participants withdrew from the research
|
10.6304 score on a scale
STANDARD_DEVIATION 4.17058 • n=46 Participants • Participants withdrew from the research
|
PRIMARY outcome
Timeframe: 6 weeksWEMWBS, Minimum: 14 Maximum: 70. Higher scores represent higher mental wellbeing
Outcome measures
| Measure |
Medical Skin Camouflage
n=23 Participants
This arm will use medical skin camouflage for 6 weeks
Medical Skin Camouflage: Medical skin camouflage is a prescription preparation designed to cover scars and other skin conditions
|
Wait List Control
n=22 Participants
This arm will receive medical skin camouflage at the end of the study
|
|---|---|---|
|
Warwick-Edinburgh Mental Well-being Scale
|
40.1739 score on a scale
Standard Deviation 8.97295
|
30.8182 score on a scale
Standard Deviation 8.46076
|
SECONDARY outcome
Timeframe: 6 weeksBSS MInimum: 0 Maximum: 28. The higher the score the greater the suicidal ideation.
Outcome measures
| Measure |
Medical Skin Camouflage
n=23 Participants
This arm will use medical skin camouflage for 6 weeks
Medical Skin Camouflage: Medical skin camouflage is a prescription preparation designed to cover scars and other skin conditions
|
Wait List Control
n=22 Participants
This arm will receive medical skin camouflage at the end of the study
|
|---|---|---|
|
Becks Scale for Suicidal Ideation
|
5.0435 score on a scale
Standard Deviation 10.20463
|
4.9412 score on a scale
Standard Deviation 6.76822
|
SECONDARY outcome
Timeframe: 6 weeksBDI-II Minimum: 0 Maximum: 63. 0-13 indicates minimal depression; 14-19 mild depression; 20-28 moderate depression and 29-63 severe depression
Outcome measures
| Measure |
Medical Skin Camouflage
n=23 Participants
This arm will use medical skin camouflage for 6 weeks
Medical Skin Camouflage: Medical skin camouflage is a prescription preparation designed to cover scars and other skin conditions
|
Wait List Control
n=22 Participants
This arm will receive medical skin camouflage at the end of the study
|
|---|---|---|
|
Becks Depression Inventory
|
25.6957 score on a scale
Standard Deviation 16.93687
|
35.1364 score on a scale
Standard Deviation 8.45884
|
SECONDARY outcome
Timeframe: 6 weeksBHS, Minimum: 0 Maximum: 20. 0-3 indicates No or minimal hopelessness; 4-8 is mild; 9-14 is moderate and 15+ is severe
Outcome measures
| Measure |
Medical Skin Camouflage
n=23 Participants
This arm will use medical skin camouflage for 6 weeks
Medical Skin Camouflage: Medical skin camouflage is a prescription preparation designed to cover scars and other skin conditions
|
Wait List Control
n=22 Participants
This arm will receive medical skin camouflage at the end of the study
|
|---|---|---|
|
Becks Hopelessness Scale
|
7.3636 score on a scale
Standard Deviation 5.57670
|
12.0000 score on a scale
Standard Deviation 6.11010
|
SECONDARY outcome
Timeframe: 6 weeksRSE Minimum: 0 Maximum: 30 Higher scores represent higher self-esteem
Outcome measures
| Measure |
Medical Skin Camouflage
n=23 Participants
This arm will use medical skin camouflage for 6 weeks
Medical Skin Camouflage: Medical skin camouflage is a prescription preparation designed to cover scars and other skin conditions
|
Wait List Control
n=22 Participants
This arm will receive medical skin camouflage at the end of the study
|
|---|---|---|
|
Rosenberg Self-Esteem Scale
|
14.8696 score on a scale
Standard Deviation 4.21366
|
12.1818 score on a scale
Standard Deviation 4.39303
|
SECONDARY outcome
Timeframe: 6 weeksAdapted-DQLI Minimum: 0 Maximum: 24 The higher the score on the Dermatology Quality of Life Index the more impaired the quality of life
Outcome measures
| Measure |
Medical Skin Camouflage
n=23 Participants
This arm will use medical skin camouflage for 6 weeks
Medical Skin Camouflage: Medical skin camouflage is a prescription preparation designed to cover scars and other skin conditions
|
Wait List Control
n=22 Participants
This arm will receive medical skin camouflage at the end of the study
|
|---|---|---|
|
Adapted-DQLI
|
6.7391 score on a scale
Standard Deviation 5.42902
|
11.9091 score on a scale
Standard Deviation 6.11718
|
Adverse Events
Medical Skin Camouflage
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Wait List Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Kerry Gutridge, Trial Manager
University of Manchester
Phone: 0161-306-7931
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place