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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07080190

Enrollment

120

Registered

2025-07-23

Start date

2022-07-01

Completion date

2023-06-30

Last updated

2025-07-23

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

Conditions

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

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.

Interventions

DRUGEarly N-Acetylcysteine

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

DRUGLate 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 30 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Mean difference of the serum creatinine	Immediately after N-Acetylcysteine Administration (Up to 1 hour)	Mean difference of the serum creatinine was recorded.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026