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Completed

NCT Number: NCT07080190

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

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

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Key information

Conditions

Urine Alkalinization Hair Dye Intoxication N-Acetylcysteine Paraphenylene Diamine

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

South Valley university

Qina, 83523, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Early N-Acetylcysteine

Drug

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

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.

Primary outcomes

  1. Mean difference of the serum creatinine

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

    Mean difference of the serum creatinine was recorded.

Sponsors and collaborators

Lead sponsor

South Valley University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 23, 2025
Registry last updated
Jul 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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