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Atopic Dermatitis (AD)NCT07323719

Comparison Between Topical N-acetyl Cysteine (NAC) in Cold Cream Versus Cold Cream in Mild and Moderate Atopic Dermatitis: Clinical and Bacteriological Evaluation. A Randomized Control Trial.

A study testing n-acetyl cyteien and cold cream in people with Atopic Dermatitis (AD), run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Atopic dermatitis (AD), or atopic eczema, is a chronic relapsing, inflammatory skin disease, characterized by intense pruritus that leads to considerable burden on patients' quality of life (Sidbury et al., 2023). Read more about this study

Who is it for?
Ages 2 to 18 years
Conditions the study is for
Atopic Dermatitis (AD)
What is being tested?
n-acetyl cyteien and cold cream
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
1 siteEgypt
Study dates
30 May 2024to 10 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Patients with atopic dermatitis defined according to Hanifin and Rajka criteria, with mild to moderate degree according to EASI score

Who cannot join

  • -Severe or erythrodermic patients and those indicated for more aggressive systemic immune suppressive therapy.
  • Patients with oozing or infected lesions
  • Patients receiving systemic treatment within one month or topical treatment within 2 weeks before enrollment into the study

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Cairo Unversity

    Cairo

Other trials in Egypt

About this study

Atopic dermatitis (AD), or atopic eczema, is a chronic relapsing, inflammatory skin disease, characterized by intense pruritus that leads to considerable burden on patients' quality of life (Sidbury et al., 2023). The dramatic rise of AD prevalence in the past half century is well documented, with prevalence reaching 15-30% of children and 2-10% of adults worldwide. Onset of the disease usually starts in childhood and although most cases resolve by adolescence, a fraction remains afflicted in adulthoodThe exact etiopathogenisis of AD is not well understood, being a complex interplay between genetic, environmental and immunological factors (Serra-Baldrich et al., 2017). Cutaneous flora imbalance in AD is well established. In particular, Staph aureus colonization is found in the vast majority of AD patients, especially in the sweat gland ducts (Gonzalez et al., 2017). Some studies found that the prevalence of Staph aureus colonization exceeds 90% of AD patients in comparison to most healthy people. In Staph. aureus- colonized AD patients, the Staph. aureus density in lesional skin was found to be more than in non-lesional skin. Recently, a temporal relationship between Staph. aureus density and clinical severity of AD was found, strongly implicating Staph. aureus in disease pathogenesis (Di Domenico et al., 2019; Ogonowska et al., 2021). Atopic dermatitis-derived Staphylococcus. epidermidis strains elicit higher inflammatory response than healthy strains.it was found that Staph. epidermidis in AD triggers inflammation by activating NF-kappa B, induces pro-inflammatory cytokines, downregulates skin barrier molecules like filaggrin and it is more prevalent in severe cases(Ochlich et al., 2023). After antimicrobial therapies targeting reduction of Staphylococcus colonization, clinical symptoms significantly decline along with resettling of diverse microflora (Brüssow, 2016). However, the propensity of Staph. aureus and Staph. epidermidis to form protective biofilms and rapid emergence of antibiotic resistance pose grave concern and prompt the search for other antimicrobial agents with less risk of resistance such as non-antibiotic antimicrobial agents and phototherapy (Brockow et al., 1999; Gonzalez et al., 2017; Man et al., 2017). Despite advances in systemic therapy for AD, topical therapies remain the mainstay of treatment due to their proven efficacy to alleviate inflammation and pruritus and generally favorable safety profile. They include emollients,corticosteroids, calcineurin inhibitors and antimicrobials (Sidbury et al., 2023).

N-acetyl cysteine (NAC) is a widely used drug in human clinical practices. It has been systemically used in the treatment of acetaminophen toxicity and as a mucolytic agent in the treatment of lower respiratory tract diseases, and its uses is recently increasing. (Janeczek et al., 2019). Regarding dermatological applications; Efficacy of N-acetyl cysteine was shown in excoriation disorder, onychophagia disorder, trichotillomania, acne vulgaris, Type I lamellar ichthyosis, bullous morphea, systemic sclerosis, toxic epidermal necrolysis, atopic dermatitis, xeroderma pigmentosum, and pseudoporphyria. Studies also show benefits in wound healing and photoprotection (Janeczek et al., 2019). N-acetyl cysteine also has antioxidant, cytoprotective, anti-inflammatory and antimicrobial properties. Oxidative stress contributes to barrier dysfunction in AD. NAC is a precursor of glutathione, a potent antioxidant which improves the barrier function. NAC also modulates cytokine production: tumor necrosis factor-alpha (TNF-α) and interleukins (IL-6 and IL-1β) by suppressing the activity of nuclear factor kappa B (NF-κB), potentially reducing the inflammatory response associated with Staph. aureus colonization. (Tenório et al., 2021) In addition, the published literature shows that NAC has an adverse effect on biofilm formation and impedes its formation at various stages. N-acetyl cysteine, as an acidic compound, applied at high concentrations, was able to penetrate the biofilm and bacterial membrane and increase the intracellular oxidative status and halt protein synthesis, in this way killing the bacterial cells (Li et al., 2020).Regarding skin hydration; NAC solution (20 w/v%) was applied to the forearm skin twice a day for 4 weeks resulted in increased skin hydration in 9/11 AD patients and decreased TEWL in 9/10 AD patients (Nakai et al., 2015). N-acetyl cysteine restored the expression of some cell adhesion molecules that contribute to forming the skin barrier in a mouse model of AD by reducing oxidative stress. Therefore, the topical application of NAC may have increased skin hydration and decreased Trans-epidermal water loss (TEWL) by strengthening the function of this barrier (Nakai et al., 2017).

Read the detailed description

Despite NAC relevant therapeutic potential, in several experimental studies, its effectiveness in clinical trials, addressing different pathological conditions, is still limited. Only one cohort study was done on humans using 20% NAC solution but 10% NAC in cold cream was the maximum concentration feasible for manufacture for our study. We first conducted a pilot study on 7 patients and it showed clinical improvement together with reduction in the colony count of Staph. aureus, therefore we decided to test this concentration on a larger scale. To the best of our knowledge, this is the first RCT conducted on atopic dermatitis patients using 10% NAC in cold cream.

Being tested
n-acetyl cyteien, cold cream
Keywords
N-acetyl cystiene, Atopic dermatitis
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • n-acetyl cyteienDrug

    n-acetyl cyteien 10% in cold cream

  • cold creamDrug

    cold cream is made of vaseline ,bees wax and other emollients as a placebo arm

Study groups in NCT07323719
Study groupRoleWhat they receive
n-acetyl cyteine armExperimentalthe interventional arm recieves n-acetyl cyteien 10% in cold cream twice daily on the lesion
Receives: Drug: n-acetyl cyteien
control armPlacebo comparatorrecieve cold cream twice daily on affected lesion
Receives: Drug: cold cream

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. microbial improvement

    • Percentage of reduction of Staphylococcus aureus and Staphylococcus epidermidis load on the skin of treated patients at EOT or EOS whichever earlier, as assessed quantitatively by Colony Forming Units (CFU) and comparing percentage of reduction between the two groups.

    Measured: 4 weeks from starting treatment

  2. clinical improvement

    • Percentage of clinical improvement using local EASI score for the chosen lesion at EOT (70% improvement or more) and comparing percentage of clinical improvement between the two groups.

    Measured: 4 weeks from starting treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2026
  2. Study start30 May 2024
  3. Primary completion1 Dec 2025
  4. Study completion10 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07323719
Sponsor's protocol ID
MD-224-2024
Status last verified
Dec 2025
First submitted
23 Dec 2025
Last updated
7 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: i would ask for participants permission first

Questions about this trial

What is this clinical trial studying?

A study testing n-acetyl cyteien and cold cream in people with Atopic Dermatitis (AD), run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

microbial improvement (time frame: 4 weeks from starting treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.

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