N-Acetyl-Cysteine for Treatment of AGA in Men

NCT04209803 | Completed Phase 4

• 1 other identifier: N-Acetyl- Cysteine for AGA
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

To study the effectiveness and safety of the reactive oxygen species scavenger N-acetyl-cysteine (NAC) as a single therapy and in combination with the topically applied minoxidil for the treatment of the early-onset androgenetic alopecia in men.

Conditions

Androgenetic Alopecia

Outcome Measures

Primary Outcomes (4)

• Assessment by digital images for effectiveness

  A photographic review of the scalp for each patient. Photos were standardized as to subject, area, distance, illumination, angle of exposure and background so that there were no major differences between any of the series of photographs. Photographs were taken using Nikon D3300 AF-P 18-55 VR 24.2 Megapixels® digital camera, based on the grading suggested by Olsen et al.,(2002) graded the photographs on a 7-point scale from dense, moderate, minimal growth, no change, minimal, moderate or dense loss. This was shown at baseline and 16 weeks of the trial.

  4 months

• Trichoscopic assessment for effectiveness

  Images were taken from fixed points in the scalp using the Dermlite П PRO HR® dermoscopy for each patient when they first presented and every month for four months. Digital images of the dermoscopic features were taken by digital camera Nikon D3300 AF-P 18-55 VR 24.2 Megapixels®. The reference points are set to the top of the vertex and a landmark for each frontal region was the intersecting point between lines passing through the ipsilateral tragus and lateral point of eyebrows. Each point was analyzed before and after follow up period by single-blinded expert in trichoscopy looking for the following parameters; total hair count, terminal hair count, vellus hair count, triple or more follicular unit, double follicular unit, single follicular unit, number of perifollicular halo (peripilar sign), thick terminal hair and thin terminal (intermediate) hair. Parameters recorded numerically then statistically analyzed for comparison between different groups of trial.

  4 months

• Patient satisfaction towards treatment outcome.

  Patient satisfaction scaled from 0 if unsatisfied, 1 is mild satisfied and 2 if satisfied and compliance with treatment was documented through a patient-filled questionnaire.

  4 months

• Side effects towards treatment used in trial.

  Side effects of the drugs (irritation, dandruff, and hypertrichosis for minoxidil plus nausea for NAC) were documented and statistically analyzed for comparison between groups of trial.

  4 months

Study Arms (4)

Minoxidil group

ACTIVE COMPARATOR

The first group will receive Minoxidil 5% topically twice daily for 4 months.

Drug: Minoxidil 5% topically and oral NAC 600 mg

NAC group

ACTIVE COMPARATOR

The second group will receive NAC orally 600 mg 3 times a day for 4 months.

Drug: Minoxidil 5% topically and oral NAC 600 mg

Minoxidil + NAC group

ACTIVE COMPARATOR

The third group will receive combined treatment of Minoxidil 5% twice daily and oral NAC 600 mg 3 times a day for 4 months.

Drug: Minoxidil 5% topically and oral NAC 600 mg

Control group

NO INTERVENTION

The fourth group will be the patients who are refusing the treatment and will be followed-up over 4 months.

Interventions

Minoxidil 5% topically and oral NAC 600 mg DRUG

Topical 5% Minoxidil and N-Acetyl-Cysteine 600 mg orally

Also known as: Hair Back scalp lotion 5% and Acetylcistein 600 mg sachet

Minoxidil + NAC group; Minoxidil group; NAC group

Eligibility Criteria

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

You may qualify if:

• Male patients between 18-30 years old affected by mild to moderate AGA up to grade IV on the Norwood-Hamilton scale.

You may not qualify if:

• Patients with contraindication to intake of NAC like patients on nitrates.
• Patients with AGA who were on systemic treatment (Finasteride, Dutasteride) in the previous 12 months.
• Patients with AGA who received topical treatment for AGA in the last 6 months.
• Patients with AGA taking any antioxidants, food and vitamin supplements within the last 3 months.
• Patients with pathological systemic diseases or environmental factors which provide a high oxidative stress state including heavy smoking, alcohol consumption, diagnosis of metabolic syndrome, and prolonged exposure to ultraviolet.

Sponsors & Collaborators

• Kafrelsheikh University: lead
• Ain Shams University: collaborator

Study Sites (1)

dermatology clinics in Ain Shams University Hospital and Kafr El Sheik University Hospital.

Cairo, 11711, Egypt

Location

Related Publications (3)

• Kaya Erdogan H, Bulur I, Kocaturk E, Yildiz B, Saracoglu ZN, Alatas O. The role of oxidative stress in early-onset androgenetic alopecia. J Cosmet Dermatol. 2017 Dec;16(4):527-530. doi: 10.1111/jocd.12300. Epub 2016 Dec 16.

  PMID: 27987270 BACKGROUND

• Mantel A, McDonald JT, Goldsborough K, Harvey VM, Chan J. Prostaglandin D2 Uses Components of ROS Signaling to Enhance Testosterone Production in Keratinocytes. J Investig Dermatol Symp Proc. 2017 Oct;18(2):S81-S84. doi: 10.1016/j.jisp.2017.01.003.

  PMID: 28941500 BACKGROUND

• Barroso LAL, Sternberg F, Souza MNIFE, Nunes GJB. Trichotillomania: a good response to treatment with N-acetylcysteine. An Bras Dermatol. 2017 Jul-Aug;92(4):537-539. doi: 10.1590/abd1806-4841.20175435.

  PMID: 28954106 BACKGROUND

MeSH Terms

Conditions

Alopecia

Interventions

Minoxidil

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Mahira H El Sayed, Professor

  Ain Shams University- Faculty of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Assistant of Dermatology and Venereology Department Kafrelsheikh University

Study Record Dates

• First Submitted: December 12, 2019
• First Posted: December 24, 2019
• Study Start: December 1, 2018
• Primary Completion: September 2, 2020
• Study Completion: October 1, 2020
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)