Early Urine Alkalinization and N-Acetylcysteine Administration in the Management of Hair Dye (Paraphenylene Diamine) Intoxication

NCT ID: NCT07080190

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2023-06-30

Brief Summary

This study aimed to determine the role of early urine alkalinization and N-acetylcysteine administration for the prevention of renal damage following hair dye intoxication

Detailed Description

Paraphenylenediamine (PPD) is an organic compound with the formula C6H4(NH2). It is the derivative of aniline, which is a white substance that turns black on oxidation, called paraphenylaniline, which is soluble in hydrogen peroxide.

Intoxication with hair dye (PPD) has become a standard method of intentional self-harm in some parts of Africa and Asia because it is cheap and readily available in the market(5).

It can cause contact dermatitis in susceptible individuals. The glutathione (GSH) levels are depleted in PPD poisoning. The antioxidant GSH plays a vital role in the maintenance of cell viability, DNA replication, and the regulation of immune cell functions. N-acetylcysteine (NAC) acts as an antioxidant both directly as a glutathione substitute and indirectly as a precursor for glutathione.

Conditions

Urine Alkalinization; N-Acetylcysteine; Hair Dye; Paraphenylene Diamine; Intoxication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study group

Patients received early N-Acetylcysteine.

Group Type: EXPERIMENTAL

Early N-Acetylcysteine

Intervention Type: DRUG

Patients received N-acetyl cysteine early (at admission) in the course of treatment of acute hair dye poisoning.

Control group

Patients received late N-Acetylcysteine.

Group Type: ACTIVE_COMPARATOR

Late N-Acetylcysteine

Intervention Type: DRUG

Patients received the standard treatment of N-acetyl cysteine after starting organ affection in the course of treatment of acute hair dye poisoning.

Interventions

Early N-Acetylcysteine

Patients received N-acetyl cysteine early (at admission) in the course of treatment of acute hair dye poisoning.

Intervention Type: DRUG

Late N-Acetylcysteine

Patients received the standard treatment of N-acetyl cysteine after starting organ affection in the course of treatment of acute hair dye poisoning.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Both sexes.
• Patients presented acutely to the emergency department with an evident history and clinical features of hair dye intoxication

Exclusion Criteria

• Renal disease.
• Hepatic disease.
• Diabetes mellitus.
• Hypertension.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

South Valley University

OTHER

Sponsor Role: lead

Responsible Party

Om koulthoum Mahmoud Abozeid Soliman

Assistant Lecturer of Forensic Medicine and Clinical Toxicology, Faculty of Medicine, South Valley University, Qena, Egypt.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

South Valley university

Qina, , Egypt

Countries

Egypt

Other Identifiers

SVU/MED/FMT010/2/22/6/412

Identifier Type: -

Identifier Source: org_study_id