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

NCT07080190 | Completed

• 1 other identifier: SVU/MED/FMT010/2/22/6/412
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Mean difference of the serum creatinine

  Mean difference of the serum creatinine was recorded.

  Immediately after N-Acetylcysteine Administration (Up to 1 hour)

Study Arms (2)

Study group

EXPERIMENTAL

Patients received early N-Acetylcysteine.

Drug: Early N-Acetylcysteine

Control group

ACTIVE COMPARATOR

Patients received late N-Acetylcysteine.

Drug: Late N-Acetylcysteine

Interventions

Early N-Acetylcysteine DRUG

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

Study group

Late N-Acetylcysteine DRUG

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

Control group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• South Valley University: lead

Study Sites (1)

South Valley university

Qina, 83523, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Forensic Medicine and Clinical Toxicology, Faculty of Medicine, South Valley University, Qena, Egypt.

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: July 23, 2025
• Study Start: July 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)