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.
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.
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.
- Conditions
- Atopic Dermatitis (AD)
- 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 group | Role | What they receive |
|---|---|---|
| n-acetyl cyteine arm | Experimental | the interventional arm recieves n-acetyl cyteien 10% in cold cream twice daily on the lesion Receives: Drug: n-acetyl cyteien |
| control arm | Placebo comparator | recieve 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.
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
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.
- First posted7 Jan 2026
- Study start30 May 2024
- Primary completion1 Dec 2025
- Study completion10 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic Dermatitis (AD)Studies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manar Saeed Salim, Cairo University
- Investigators
- Samar Ragaie El-tahlawi, Professo, Study director, Cairo University
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07323719
- Acronym / sponsor ID
- MD-224-2024
- Conditions
- Atopic Dermatitis (AD)
- Keywords
- N-acetyl cystiene, Atopic dermatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 May 2024 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 10 Dec 2025 (actual)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| n-acetyl cyteine arm | Experimental | Drug: n-acetyl cyteienthe interventional arm recieves n-acetyl cyteien 10% in cold cream twice daily on the lesion |
| control arm | Placebo comparator | Drug: cold creamrecieve cold cream twice daily on affected lesion |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients with atopic dermatitis defined according to Hanifin and Rajka criteria, with mild to moderate degree according to EASI score
Key exclusion criteria (3 listed)
- -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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| n-acetyl cyteienn-acetyl cyteien 10% in cold cream | Drug | n-acetyl cyteine arm |
| cold creamcold cream is made of vaseline ,bees wax and other emollients as a placebo arm | Drug | control arm |
Primary outcome
microbial improvement
Time frame: 4 weeks from starting treatment
- 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.
clinical improvement
Time frame: 4 weeks from starting treatment
- 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Individual participant dataSharing planned: Undecided. i would ask for participants permission first
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samar Ragaie El-tahlawi, Professo study director
Cairo University
1 site in 1 country: see every site and its status.
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.