N-Acetyl-Cysteine for Treatment of AGA in Men

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Brief Title

N-Acetyl-Cysteine for Treatment of AGA in Men

Official Title

Efficacy and Tolerability of N-Acetyl- Cysteine for Treatment of The Early-onset Androgenetic Alopecia in Men

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.
    

Detailed Description

      Androgenetic alopecia (AGA) is a non-scarring disease with a progressive thinning of the
      scalp hair that follows a characteristic pattern. AGA, the most common form of hair loss in
      men, involves the progressive loss of visible pigmented terminal hair on the scalp in
      response to circulating androgens. AGA is an autosomal disorder that begins in puberty in
      genetically predisposed individuals. Thinning usually begins between the age of 12 and 40
      years in both sexes, and at least 50% of the men by the age of 50 and 50% of women by 60
      years are more affected. The pathogenesis of androgenetic alopecia involves both genetic and
      hormonal factors. The hair follicles are genetically targeted for androgen stimulation
      leading to follicular miniaturization and replacement of large pigmented hairs (terminal
      hairs) with shorter, thinner depigmented hairs (vellus hairs) in affected areas.
      Environmental factors, the nutritional influences, metabolic syndrome, smoking, and UV
      radiation, also play a role in the pathogenesis of AGA. Recent histological studies
      illustrated perifollicular inflammation in the upper third of the hair follicles, suggesting
      that inflammation plays a pathogenic role in AGA, although clinically, AGA is considered a
      non-inflammatory disease. Oxidative stress and inflammation are closely linked in biological
      systems. The enhanced hair loss in androgenetic alopecia was linked to several factors that
      increase cellular oxidative stress, including metabolic syndrome, alcohol consumption,
      smoking, and UV radiation. AGA patients were found to suffer from oxidative stress as
      evidenced by the decreased total antioxidant activity as well as increased malondialdehyde
      levels. Erdogan et al.investigated the oxidative stress in early-onset androgenetic alopecia
      and found that the total oxidant levels and oxidative stress index are higher in younger
      patients with early-onset AGA. Molecular studies of the paracrine mediators around the dermal
      papilla cells have shed light on the role played by ROS in bald scalp. Prostaglandin D2
      (PGD2) was found to be elevated in the bald scalp of AGA patients and negatively affected the
      growth of human hair. PGD2 was found to enhance the capacity of human keratinocytes to
      convert the weak androgen, androstenedione, to testosterone through the involvement of the
      ROS cellular signaling axis. The ROS scavenger, N-acetyl-cysteine, blocked the enhanced
      testosterone production by PGD2. Transforming growth factor-beta (TGF-β) is another key
      promotor of hair follicle apoptosis. TGF-β was found to be androgen-inducible via the
      induction of ROS and its induction was significantly suppressed by the ROS-scavenger,
      N-acetyl cysteine in the hair follicle dermal papilla cells. Treatment of cases of
      androgenetic alopecia comprises a therapeutic challenge. AGA is neither life-threatening nor
      does it lead to pain; however, it leads to a significant emotional burden and is considered
      as a therapeutically frustrating disorder to the patients. The therapeutic approach to the
      patient with androgenetic alopecia should be global: combined treatments may obtain
      improvements in hair density, reduction of miniaturization and hair loss. Minoxidil 2% or 5%
      solution is the most frequently used drug for topical application. In men with AGA, 5%
      topical minoxidil was clearly superior to 2% topical minoxidil in increasing hair regrowth.

      Men who used 5% topical minoxidil also had an earlier response to treatment than those who
      used 2% topical minoxidil. Psychosocial perceptions of hair loss in men with AGA were also
      improved. Finasteride, a selective inhibitor of 5α- reductase of type II reduces the
      conversion of testosterone into DHT, was approved by FDA in 1997 in a dosage of 1 mg/day as a
      systemic therapy in adult men with mild to moderate AGA. N-acetylcysteine (NAC) has been
      widely used as an antioxidant in vivo and in vitro. N-Acetylcysteine may act as a precursor
      of glutathione facilitating its biosynthesis. Glutathione will then serve as a protective
      agent and detoxify reactive species both enzymatically and non-enzymatically. It is possible
      that N-acetylcysteine could scavenge the active oxygen species directly by non-enzymatic
      reduction. By replenishing glutathione, NAC can prevent paracetamol toxicity. NAC is
      traditionally used as a hepatoprotective agent for the treatment of paracetamol toxicity. Its
      mucolytic and anti-inflammatory actions allow its successful use in chronic bronchopulmonary
      disease. Dermatologically, NAC in a dose ranging from 1200 mg/day up to 2400 mg/day
      constitutes an effective treatment of trichotillomania owing to its glutamate modulating
      action via the reduction of oxidative stress and normalization of glutaminergic transmission.
      It is generally well tolerated with a high safety profile, mild gastrointestinal symptoms
      like vomiting and diarrhea are the most common side effects. Given that oxidative stress
      emerges as a new component in the multifactorial milieu of the aetiopathogenesis of AGA; the
      proved high oxidative stress index in patients with early-onset androgenetic alopecia; the
      established in vitro efficacy of ROSscavenger, N-acetyl cysteine, in blocking ROS and
      subsequently the inhibitory paracrine mediators (PGD2 & TGF-β) of the hair follicle dermal
      papilla in the bald scalp; together with the high safety profile and tolerability of NAC, the
      investigators thought to investigate the efficacy and tolerability of NAC as a single therapy
      and in combination with minoxidil for treatment of the early-onset androgenetic alopecia in
      men.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Assessment by digital images for effectiveness


Condition

Androgenetic Alopecia

Intervention

Minoxidil 5% topically and oral NAC 600 mg

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

100

Start Date

December 1, 2018

Completion Date

October 2020

Primary Completion Date

September 2020

Eligibility 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.
      

Gender

Male

Ages

18 Years - 30 Years

Accepts Healthy Volunteers

No

Contacts

Mahira H El Sayed, Professor, 01007981008, [email protected]

Location Countries

Egypt

Location Countries

Egypt

Administrative Informations


NCT ID

NCT04209803

Organization ID

N-Acetyl- Cysteine for AGA


Responsible Party

Principal Investigator

Study Sponsor

Kafrelsheikh University

Collaborators

 Ain Shams University

Study Sponsor

Mahira H El Sayed, Professor, Study Chair, Ain Shams University- Faculty of Medicine


Verification Date

February 2020