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Intramuscular glutathione as a systemic whitening agent

Evaluation of Efficacy and Safety of intramuscular glutathione as a systemic whitening agent: a double blinded randomized controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR201907742980888
Enrollment
30
Registered
2019-07-04
Start date
2019-06-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin and Connective Tissue Diseases

Interventions

Group 1
Group 2

Sponsors

Sohag University Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Healthy female aged between 18 to 50 years old fitzpatric skin type III and V.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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). ;Laboratory investigations: Complete blood picture- liver functions- serum creatinine- Thyroid stimulating hormone (TSH).;Safety evaluation: Any adverse effects noticed by participants and or physician will reported during the treatment and the follow up period.

Secondary

MeasureTime frame
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). ;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).

Countries

Egypt

Contacts

Public ContactAlaa ;Essam A Mostafa;Nada

Resident at Department of Dermatology Albaliana Hospital Sohag;Professor of Dermatology Faculty of Medicine Sohag University

alaa_mostafa_ahmed88@hotmail.com;amradva@yahoo.com00201020486388;00201093330030

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026