Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00283

2 Trial Registration Date

2011-03-04

i Registration Status

Prospective

3 Secondary IDs

None

4 Source(s) of Funding

Shen Wei, USA, Inc

5 Primary Sponsor

Shen Wei, USA, Inc

6 Secondary Sponsor

Nil

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Hon KL

ii Address

Dept of Paediatrics

iii Phone

26322859

iv Email

ehon@hotmail.com

v Affiliation

CUHK

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Hon KL

ii Address

Dept of Paediatrics

iii Phone

26322859

iv Email

ehon@hotmail.com

v Affiliation

CUHK

vi Country

9 Official Scientific Title of the Study

A randomised, double-blind, controlled study to evaluate the effect of Aloe Vera Examination Gloves, compared to Standard Powder Free Nitrite Examination Gloves, on trans-epidermal water loss and hand dermatitis among health care workers

10 Public Title

A randomised, double-blind, controlled study to evaluate the effect of Aloe Vera Examination Gloves, compared to Standard Powder Free Nitrite Examination Gloves, on trans-epidermal water loss and hand dermatitis among health care workers

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

Nil

12 Countries of Recruitment

Hong Kong, China

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2011-02-09

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Hand condition

15 Intervention

i Types of intervention

Other

Please specify

RCT

ii Description/ name of Intervention/article

Gloves with aloe vera

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

4 weeks

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Gloves without aloe vera

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

A total of 20 subjects, who fulfil the following inclusion criteria, will be recruited:
1. Female or male health care workers (nurses, nursing students or laboratory personnel) working in a hospital setting
2. Age 18-60 years (inclusive)
3. Subjects with history of or current dry skin condition or irritant contact dermatitis of hands
4. Subjects otherwise healthy and free from other sickness and diseases
5. Female subjects of childbearing potential, who agree to use physician-approved contraceptive regimen during the whole study period
6. Subjects giving free consent to comply with the scheduled study procedures and clinical evaluations

ii Exclusion Criteria

1. Subjects with known allergy to latex
2. Subjects with known allergy to aloe vera
3. Subjects suffering from severe contact dermatitis or atopic dermatitis
4. Subjects suffering from severe allergic skin conditions, psoriasis, urticaria or having skin fissures, excoriations etc. that would, in the opinion of the investigator, not be suitable to participate
5. Subjects suffering from any active fungal or bacterial infection
6. Subjects taking oral steroid for any condition or using topical steroid preparations for their hands
7. Female subjects who are pregnant or lactating
8. Any criteria which in the opinion of the investigator, suggests that the subjects would not be compliant with the study protocol

iii Age Minimum

18

iv Age Maximum

60

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Placebo

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Single group

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2011-03-11

21 Target Sample Size

20-22

22 Recruitment Status

Unknown

23 Primary Outcome

Reduction in TEWL from baseline to Day 14, Day 28 and Day 30

24 Secondary Outcome

Reduction of Physician assessed contact dermatitis scores from baseline to Day 14, Day 28 and Day 30
2. Improvement in Subjects assessed skin condition scores from baseline to Day 14, Day 28 and Day 30

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2012-05-16

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-11001267

28 Date of Registration in Primary Registry

2011-04-15

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

Nil

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Trial History Detail on 2013-09-11