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N-Acetyl-Cysteine for Treatment of AGA in Men

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04209803
Recruitment Status : Recruiting
First Posted : December 24, 2019
Last Update Posted : February 20, 2020
Sponsor:
Collaborator:
Ain Shams University
Information provided by (Responsible Party):
Mohamed Abo Shabana Hussein Mohamed, Kafrelsheikh University

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.

Condition or disease Intervention/treatment Phase
Androgenetic Alopecia Drug: Minoxidil 5% topically and oral NAC 600 mg Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Tolerability of N-Acetyl- Cysteine for Treatment of The Early-onset Androgenetic Alopecia in Men
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Minoxidil group
The first group will receive Minoxidil 5% topically twice daily for 4 months.
Drug: Minoxidil 5% topically and oral NAC 600 mg
Topical 5% Minoxidil and N-Acetyl-Cysteine 600 mg orally
Other Name: Hair Back scalp lotion 5% and Acetylcistein 600 mg sachet

Active Comparator: NAC group
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
Topical 5% Minoxidil and N-Acetyl-Cysteine 600 mg orally
Other Name: Hair Back scalp lotion 5% and Acetylcistein 600 mg sachet

Active Comparator: Minoxidil + NAC group
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
Topical 5% Minoxidil and N-Acetyl-Cysteine 600 mg orally
Other Name: Hair Back scalp lotion 5% and Acetylcistein 600 mg sachet

No Intervention: Control group
The fourth group will be the patients who are refusing the treatment and will be followed-up over 4 months.



Primary Outcome Measures :
  1. Assessment by digital images for effectiveness [ Time Frame: 4 months ]
    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.

  2. Trichoscopic assessment for effectiveness [ Time Frame: 4 months ]
    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.

  3. Patient satisfaction towards treatment outcome. [ Time Frame: 4 months ]
    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. Side effects towards treatment used in trial. [ Time Frame: 4 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04209803


Contacts
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Contact: Mohamed S Hussein, Demonstrator 01007981008 dr.mohamedaboshabana@gmail.com
Contact: Marwa Y Soltan, Lecturer

Locations
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Egypt
dermatology clinics in Ain Shams University Hospital and Kafr El Sheik University Hospital. Recruiting
Cairo, Egypt, 11711
Contact: Mohamed Abo Shabana    01007981008    dr.mohamedaboshabana@gmail.com   
Sponsors and Collaborators
Kafrelsheikh University
Ain Shams University
Investigators
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Study Chair: Mahira H El Sayed, Professor Ain Shams University- Faculty of Medicine
Publications:
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Responsible Party: Mohamed Abo Shabana Hussein Mohamed, Teaching Assistant of Dermatology and Venereology Department Kafrelsheikh University, Kafrelsheikh University
ClinicalTrials.gov Identifier: NCT04209803    
Other Study ID Numbers: N-Acetyl- Cysteine for AGA
First Posted: December 24, 2019    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Minoxidil
Antihypertensive Agents
Vasodilator Agents