Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201907742980888 Date of Approval: 04/07/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Intramuscular glutathione as a systemic whitening agent
Official scientific title Evaluation of Efficacy and Safety of intramuscular glutathione as a systemic whitening agent: a double blinded randomized controlled clinical trial
Brief summary describing the background and objectives of the trial Getting a lighter skin tone always draws a lot of interest, especially for women. Women in some cases, their marriage prospects or career opportunities are dominated by the hue of their skin. There are limited studies about the glutathione as a systemic withering agent. The intravenous Glutathione is limited in use because of complications and the oral form is less effected. Therefore, we conduct this trial to demonstrate the efficacy and safety of IM glutathione as a systemic whitening agent.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Skin and Connective Tissue Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/06/2019
Actual trial start date
Anticipated date of last follow up 31/10/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Group 1 1 ml saline Injection will be every week for 2 months Intra-muscular injection of saline 15 Placebo
Experimental Group Group 2 600 mg of Glutathione in 1 ml Glutathione injection will be done every week for 2 months Intra-muscular injection of glutathione 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Healthy female aged between 18 to 50 years old fitzpatric skin type III and V. Personal or family history of skin cancer, especially melanoma. Consumption of any preparations containing glutathione within 1month of enrollment. Pigmentary disorders or any dermatoses, which may affect the measurement within the study areas. Known hypersensitivity to glutathione. Current pregnancy and lactation. Current use of oral contraceptive pills or current receipt of hormone replacement therapy. Regular participation in vigorous activities (e.g. sports) that includes exercise; occupational or leisure activities that involve daily sun exposure between 10.00 hours and 15.00 hours A history of autoimmune disease, or immunodeficiency. Major surgery, active or recent systemic infection within the previous four weeks. History of liver diseases. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 50 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 01/05/2019 Sohag University Faculty of Medicine ethical committee
Ethics Committee Address
Street address City Postal code Country
Nasr city district Sohag 82524 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome High-resolution photographs will be taken using smart phone, before treatment, at the end of treatment, 3 months after end of treatment to : Sun exposed areas: Face (left and right sides)- extensor surface of forearm. Sun protected areas: mid-sternum, upper & inner arms (left and right). Using a physician visual analog scoring system, 2 independent dermatologists will rate the patient’s overall aesthetic improvement from 0-10 based on a comparison between the baseline, end of therapy and 3 months follow up visit photographs (Barikbin et al., 2017). 0, 1, 2, 5 months
Secondary Outcome Patients satisfaction Participant will be asked to grade the over all response using a 4 point rating scale: as follows, 4-very satisfactory; 3-moderately satisfactory; 2-minimally satisfactory; 1-not satisfactory (Arjinpathana and Asawanonda, 2012). 0, 1, 2, 5 months
Secondary Outcome The Dermatology Life Quality Index (DLQI): The DLQI consists of 10 questions concerning symptoms and feelings, daily activities, leisure, work, and school, personal relationships and treatment. Each question is answered by a tick box: ‘‘not at all’’, ‘‘a little’’, ‘‘a lot’’ or ‘‘very much’’. Each question is scored from0 to 3 and the scores summed, giving a range from 0 (no impairment of life quality) to 30 (maximum impairment). All questions relate ‘‘to the last week’’. The DLQI was designed to be used in adults over the age of 18 years (Finlay and Khan, 1994). 0, 1, 2, 5 months
Primary Outcome Laboratory investigations: Complete blood picture- liver functions- serum creatinine- Thyroid stimulating hormone (TSH). 0, 1, 2, 5 months
Primary Outcome Safety evaluation: Any adverse effects noticed by participants and or physician will reported during the treatment and the follow up period. 0, 1, 2, 5 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Sohag University Hospitals Nasr city district Sohag 82524 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Amr Abdelhamed Nasr city district Sohag Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Sohag University Hospital Nasr city district Sohag 82524 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Essam A Nada Nasr city district Sohag Egypt
Alaa Mostafa Nasr city district Nasr Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amr Abdelhamed dramr80@yahoo.com 00201005825574 Nasr city district
City Postal code Country Position/Affiliation
Sohag 82524 Egypt Lecturer and consultant of Dermatology Faculty of Medicine Sohag University
Role Name Email Phone Street address
Public Enquiries Alaa Mostafa alaa_mostafa_ahmed88@hotmail.com 00201020486388 Nasr city district
City Postal code Country Position/Affiliation
Sohag Egypt Resident at Department of Dermatology Albaliana Hospital Sohag
Role Name Email Phone Street address
Scientific Enquiries Amr Abdelhamed dramr80@yahoo.com 00201005825574 Nasr city district
City Postal code Country Position/Affiliation
Sohag 82524 Egypt Lecturer and consultant of Dermatology Faculty of Medicine Sohag University
Role Name Email Phone Street address
Public Enquiries Essam A Nada amradva@yahoo.com 00201093330030 Nasr city district
City Postal code Country Position/Affiliation
Sohag Egypt Professor of Dermatology Faculty of Medicine Sohag University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will include socio demographic, laboratory, and clinical participant data. Also, the IPD will include the different primary and secondary outcomes of the study. Informed Consent Form,Statistical Analysis Plan,Study Protocol 1, 2, 5 months Laboratory and clinical outcomes
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information