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Skin Camouflage for Women Prisoners With Self-Harm Scarring (COVER)

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ClinicalTrials.gov Identifier: NCT02638974
Recruitment Status : Completed
First Posted : December 23, 2015
Results First Posted : October 18, 2019
Last Update Posted : October 18, 2019
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
Kerry Gutridge, University of Manchester

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Self Injurious Behaviour
Intervention Other: Medical Skin Camouflage
Enrollment 51
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Medical Skin Camouflage Wait List Control
Hide Arm/Group Description

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

This arm will receive medical skin camouflage at the end of the study
Period Title: Overall Study
Started 26 25
Completed 23 22
Not Completed 3 3
Arm/Group Title Medical Skin Camouflage Wait List Control Total
Hide Arm/Group Description

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

This arm will receive medical skin camouflage at the end of the study Total of all reporting groups
Overall Number of Baseline Participants 26 25 51
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 23 participants 23 participants 46 participants
31
(21 to 47)
29
(19 to 51)
30
(19 to 51)
[1]
Measure Analysis Population Description: Participants withdrew from the research
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 23 participants 46 participants
Female
23
 100.0%
23
 100.0%
46
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Analysis Population Description: Participants withdrew from the research
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Ethnicity Number Analyzed 23 participants 23 participants 46 participants
White
22
  95.7%
22
  95.7%
44
  95.7%
Non-white
1
   4.3%
1
   4.3%
2
   4.3%
[1]
Measure Analysis Population Description: Participants withdrew from the research
Adapted-Dermatology Quality of Life Index   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 23 participants 23 participants 46 participants
12.6957  (3.95928) 12.2609  (6.51723) 12.4783  (5.33641)
[1]
Measure Description: Adapted DQLI Minimum 0, Maxium 24. The higher the score ont he DQLI, the more impaired the quality of life.
[2]
Measure Analysis Population Description: Participants withdrew from the study so their data was not analysed
Beck's Depression Inventory   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 23 participants 23 participants 46 participants
33.6957  (11.39950) 38.9565  (6.99011) 36.3261  (9.72066)
[1]
Measure Description: BDI-II Minimum 0 Maximum 63. 0-13 indicates minimal depression, 14-19 mild depression, 20-28 moderate depression, 29-63 severe depression
[2]
Measure Analysis Population Description: Participants withdrew from the research
Beck's Hopelessness Scale   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 23 participants 23 participants 46 participants
10.0000  (5.86980) 14.6957  (4.43575) 12.3478  (5.66556)
[1]
Measure Description: BHS Minimum 0 Maximum 20. 0-3 indicates no or minimal hopelessness, 4-8 is mild, 9-14 is moderate and 15+ is severe
[2]
Measure Analysis Population Description: Participants withdrew from the research.
Beck's Scale for Suicide Ideation   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 22 participants 22 participants 44 participants
6.2273  (7.75783) 8.8636  (8.66463) 7.5455  (8.23621)
[1]
Measure Description: BSS Minimum 0 Maximum 28. The higher the score the greater the suicidal ideation.
[2]
Measure Analysis Population Description: Participants withdrew from the research or decline to answer this scale
Warwick-Edinburgh Mental Wellbeing Scale   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 23 participants 23 participants 46 participants
36.0435  (11.17008) 30.2609  (9.12647) 33.1522  (10.50072)
[1]
Measure Description: WEMWBS Minimum 14 Maximum 70. Higher scores represent higher wellbeing
[2]
Measure Analysis Population Description: Participants withdrew from the research.
Rosenberg Self Esteem Scale   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 23 participants 23 participants 46 participants
11.6522  (4.68662) 9.6087  (3.38095) 10.6304  (4.17058)
[1]
Measure Description: RSE Minimum 0 Maximum 30. Higher scores represent higher self esteem.
[2]
Measure Analysis Population Description: Participants withdrew from the research
1.Primary Outcome
Title Warwick-Edinburgh Mental Well-being Scale
Hide Description WEMWBS, Minimum: 14 Maximum: 70. Higher scores represent higher mental wellbeing
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Medical Skin Camouflage Wait List Control
Hide Arm/Group Description:

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

This arm will receive medical skin camouflage at the end of the study
Overall Number of Participants Analyzed 23 22
Mean (Standard Deviation)
Unit of Measure: score on a scale
40.1739  (8.97295) 30.8182  (8.46076)
2.Secondary Outcome
Title Becks Scale for Suicidal Ideation
Hide Description BSS MInimum: 0 Maximum: 28. The higher the score the greater the suicidal ideation.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Medical Skin Camouflage Wait List Control
Hide Arm/Group Description:

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

This arm will receive medical skin camouflage at the end of the study
Overall Number of Participants Analyzed 23 22
Mean (Standard Deviation)
Unit of Measure: score on a scale
5.0435  (10.20463) 4.9412  (6.76822)
3.Secondary Outcome
Title Becks Depression Inventory
Hide Description BDI-II Minimum: 0 Maximum: 63. 0-13 indicates minimal depression; 14-19 mild depression; 20-28 moderate depression and 29-63 severe depression
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Medical Skin Camouflage Wait List Control
Hide Arm/Group Description:

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

This arm will receive medical skin camouflage at the end of the study
Overall Number of Participants Analyzed 23 22
Mean (Standard Deviation)
Unit of Measure: score on a scale
25.6957  (16.93687) 35.1364  (8.45884)
4.Secondary Outcome
Title Becks Hopelessness Scale
Hide Description BHS, Minimum: 0 Maximum: 20. 0-3 indicates No or minimal hopelessness; 4-8 is mild; 9-14 is moderate and 15+ is severe
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Medical Skin Camouflage Wait List Control
Hide Arm/Group Description:

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

This arm will receive medical skin camouflage at the end of the study
Overall Number of Participants Analyzed 23 22
Mean (Standard Deviation)
Unit of Measure: score on a scale
7.3636  (5.57670) 12.0000  (6.11010)
5.Secondary Outcome
Title Rosenberg Self-Esteem Scale
Hide Description RSE Minimum: 0 Maximum: 30 Higher scores represent higher self-esteem
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Medical Skin Camouflage Wait List Control
Hide Arm/Group Description:

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

This arm will receive medical skin camouflage at the end of the study
Overall Number of Participants Analyzed 23 22
Mean (Standard Deviation)
Unit of Measure: score on a scale
14.8696  (4.21366) 12.1818  (4.39303)
6.Secondary Outcome
Title Adapted-DQLI
Hide Description Adapted-DQLI Minimum: 0 Maximum: 24 The higher the score on the Dermatology Quality of Life Index the more impaired the quality of life
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Medical Skin Camouflage Wait List Control
Hide Arm/Group Description:

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

This arm will receive medical skin camouflage at the end of the study
Overall Number of Participants Analyzed 23 22
Mean (Standard Deviation)
Unit of Measure: score on a scale
6.7391  (5.42902) 11.9091  (6.11718)
Time Frame 9 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Medical Skin Camouflage Wait List Control
Hide Arm/Group Description

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

This arm will receive medical skin camouflage at the end of the study
All-Cause Mortality
Medical Skin Camouflage Wait List Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)   0/25 (0.00%) 
Hide Serious Adverse Events
Medical Skin Camouflage Wait List Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)   0/25 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Medical Skin Camouflage Wait List Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)   0/25 (0.00%) 
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 Kerry Gutridge, Trial Manager
Organization: University of Manchester
Phone: 0161-306-7931
EMail: kerry.gutridge@manchester.ac.uk
Layout table for additonal information
Responsible Party: Kerry Gutridge, University of Manchester
ClinicalTrials.gov Identifier: NCT02638974    
Other Study ID Numbers: 15438
First Submitted: November 18, 2015
First Posted: December 23, 2015
Results First Submitted: May 30, 2019
Results First Posted: October 18, 2019
Last Update Posted: October 18, 2019