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

South Valley University

Status: Completed

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

Treatments: Drug: Early N-Acetylcysteine; Drug: Late N-Acetylcysteine

Study type: Interventional

Funder types: Other

Identifiers

NCT07080190

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

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 30 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Study group

Experimental group

Description:

Patients received early N-Acetylcysteine.

Treatment:

Drug: Early N-Acetylcysteine

Control group

Active Comparator group

Description:

Patients received late N-Acetylcysteine.

Treatment:

Drug: Late N-Acetylcysteine