Disinfectant Causing Toxic EffectNCT05937412
A Comparative Study Between Honey and Alcohol as Topical Skin Disinfectant
A study testing Alcohol sterilization and Honey sterilization in people with Disinfectant Causing Toxic Effect, run by Ain Shams University at 1 site in Egypt.
Trial summary
Skin antisepsis is essential in every healthcare environment. Alcohol/chlorhexidine use might disrupt skin microbiota and lead to antibiotic resistance. This study investigates honey (being natural product with many beneficial therapeutic effects) as topical skin anti-septic agent and compares it with alcohol, in… Read more about this study
- Who is it for?
- Ages 2 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Disinfectant Causing Toxic Effect
- What is being tested?
- Alcohol sterilization and Honey sterilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Aug 2023to 28 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- - Children aged from 2 to 12 years, of both sexes, and with apparently healthy skin.
- Children, who did not receive any form of antimicrobial agent for at least one-week prior study.
Who cannot join
- - Immuno-compromised due to diseases or drugs.
- - Children having any skin disease as eczema or others
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University, Cairo
Cairo, Cairo Governorate, 1181
About this study
Skin antisepsis is essential in every healthcare environment. Alcohol/chlorhexidine use might disrupt skin microbiota and lead to antibiotic resistance.
This study investigates honey (being natural product with many beneficial therapeutic effects) as topical skin anti-septic agent and compares it with alcohol, in terms of effectiveness and safety.
Read the detailed description
Recent years' investigations of the co-evolution and functional integration of the human body and its commensal microbiota have disclosed that the microbiome has a major impact on physiological functions including protection against infections.
Invasive procedures such as injections, punctures or surgeries penetrate the skin's natural protective barrier, which may allow pathogenic microorganisms to enter deeper skin layers and cavities and trigger infections there.
Alcohols usually in the form of 70% isopropyl alcohol or 60 to 80% ethyl alcohol, are commonly used topical disinfectants.
Despite being efficiently broad-spectrum antiseptic, Alcohol shows some local hazards affecting skin integrity and microbiome.
Honey has been used in wound care since ancient. It has many beneficial therapeutic effects, including anti-microbia, antioxidant, immune-modulator, wound healing and synbiotic effects .
Antimicrobial agents are important in reducing the burden of infectious diseases.
- Conditions
- Disinfectant Causing Toxic Effect
- Being tested
- Alcohol sterilization, Honey sterilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol sterilizationOther
Sterilizing skin using alcohol
Honey sterilizationOther
Sterilizing skin using honey
| Study group | Role | What they receive |
|---|---|---|
| alcohol group | Active comparator | 70% isopropyl alcohol will be topically applied and spread uniformly on a prespecified area of at least 3 cm x 3cm on the dorsum of the hand. A skin swab will be obtained from the selected skin area just before and 20 seconds after topical application of alcohol and honey. Receives: Other: Alcohol sterilization |
| honey group | Active comparator | honey will be topically applied and spread uniformly on a prespecified area of at least 3 cm x 3cm on the dorsum of the hand. A skin swab will be obtained from the selected skin area just before and 20 seconds after topical application of alcohol and honey. Receives: Other: Honey sterilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess efficacy of honey as a disinfectant in comparison to the standard disinfectant which is alcohol
taking a swab from skin for culture of organisms after application of either alcohol or honey and compare type of organisms and number of colony forming units
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start30 Aug 2023
- Primary completion15 Jul 2025 (estimated)
- Study completion28 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Disinfectant Causing Toxic EffectStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- mamdouh abdelmaksoud, Study director, Ain Shams Universityyosra awad, Study director, Ain Shams Universitymaha ahmad, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05937412
- Sponsor's protocol ID
- MS 312/2022
- Status last verified
- Apr 2025
- First submitted
- 10 Dec 2022
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Breasted JH. (1930): The Edwin Smith papyrus: published in facsimile and hieroglyphic transliteration. Chicago: University of Chicago Press.
Wiemken TL. Skin antiseptics in healthcare facilities: is a targeted approach necessary? BMC Public Health. 2019 Aug 22;19(1):1158. doi: 10.1186/s12889-019-7507-5.
PubMed 31438910Gheldof N, Engeseth NJ. Antioxidant capacity of honeys from various floral sources based on the determination of oxygen radical absorbance capacity and inhibition of in vitro lipoprotein oxidation in human serum samples. J Agric Food Chem. 2002 May 8;50(10):3050-5. doi: 10.1021/jf0114637.
PubMed 11982440Hasyimi W, Widanarni W, Yuhana M. Growth Performance and Intestinal Microbiota Diversity in Pacific White Shrimp Litopenaeus vannamei Fed with a Probiotic Bacterium, Honey Prebiotic, and Synbiotic. Curr Microbiol. 2020 Oct;77(10):2982-2990. doi: 10.1007/s00284-020-02117-w. Epub 2020 Jul 18.
PubMed 32683466Held E, Mygind K, Wolff C, Gyntelberg F, Agner T. Prevention of work related skin problems: an intervention study in wet work employees. Occup Environ Med. 2002 Aug;59(8):556-61. doi: 10.1136/oem.59.8.556.
PubMed 12151613Jull AB, Cullum N, Dumville JC, Westby MJ, Deshpande S, Walker N. Honey as a topical treatment for wounds. Cochrane Database Syst Rev. 2015 Mar 6;2015(3):CD005083. doi: 10.1002/14651858.CD005083.pub4.
PubMed 25742878Majtan J. Honey: an immunomodulator in wound healing. Wound Repair Regen. 2014 Mar-Apr;22(2):187-92. doi: 10.1111/wrr.12117. Epub 2014 Feb 24.
PubMed 24612472Mandal MD, Mandal S. Honey: its medicinal property and antibacterial activity. Asian Pac J Trop Biomed. 2011 Apr;1(2):154-60. doi: 10.1016/S2221-1691(11)60016-6.
PubMed 23569748Christensen GJ, Bruggemann H. Bacterial skin commensals and their role as host guardians. Benef Microbes. 2014 Jun 1;5(2):201-15. doi: 10.3920/BM2012.0062.
PubMed 24322878Sato T, Miyata G. The nutraceutical benefit, part iii: honey. Nutrition. 2000 Jun;16(6):468-9. doi: 10.1016/s0899-9007(00)00271-9. No abstract available.
PubMed 10869910Trevisanato SI. Treatments for burns in the London Medical Papyrus show the first seven biblical plagues of Egypt are coherent with Santorini's volcanic fallout. Med Hypotheses. 2006;66(1):193-6. doi: 10.1016/j.mehy.2005.08.052. Epub 2005 Oct 14.
PubMed 16226847
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between Honey and Alcohol as Topical Skin Disinfectant
- ClinicalTrials.gov ID
- NCT05937412
- Acronym / sponsor ID
- MS 312/2022
- Conditions
- Disinfectant Causing Toxic Effect
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 30 Aug 2023 (actual)
- Primary completion
- 15 Jul 2025 (estimated)
- Study completion
- 28 Aug 2025 (estimated)
- First posted
- 10 Jul 2023 (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.
Skin antisepsis is essential in every healthcare environment. Alcohol/chlorhexidine use might disrupt skin microbiota and lead to antibiotic resistance.
This study investigates honey (being natural product with many beneficial therapeutic effects) as topical skin anti-septic agent and compares it with alcohol, in terms of effectiveness and safety.
Detailed description
Recent years' investigations of the co-evolution and functional integration of the human body and its commensal microbiota have disclosed that the microbiome has a major impact on physiological functions including protection against infections.
Invasive procedures such as injections, punctures or surgeries penetrate the skin's natural protective barrier, which may allow pathogenic microorganisms to enter deeper skin layers and cavities and trigger infections there.
Alcohols usually in the form of 70% isopropyl alcohol or 60 to 80% ethyl alcohol, are commonly used topical disinfectants.
Despite being efficiently broad-spectrum antiseptic, Alcohol shows some local hazards affecting skin integrity and microbiome.
Honey has been used in wound care since ancient. It has many beneficial therapeutic effects, including anti-microbia, antioxidant, immune-modulator, wound healing and synbiotic effects .
Antimicrobial agents are important in reducing the burden of infectious diseases.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| alcohol group | Active comparator | Other: Alcohol sterilization70% isopropyl alcohol will be topically applied and spread uniformly on a prespecified area of at least 3 cm x 3cm on the dorsum of the hand. A skin swab will be obtained from the selected skin area just before and 20 seconds after topical application of alcohol and honey. |
| honey group | Active comparator | Other: Honey sterilizationhoney will be topically applied and spread uniformly on a prespecified area of at least 3 cm x 3cm on the dorsum of the hand. A skin swab will be obtained from the selected skin area just before and 20 seconds after topical application of alcohol and honey. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- - Children aged from 2 to 12 years, of both sexes, and with apparently healthy skin.
- Children, who did not receive any form of antimicrobial agent for at least one-week prior study.
Key exclusion criteria (2 listed)
- - Immuno-compromised due to diseases or drugs.
- - Children having any skin disease as eczema or others
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 |
|---|---|---|
| Alcohol sterilizationSterilizing skin using alcohol | Other | alcohol group |
| Honey sterilizationSterilizing skin using honey | Other | honey group |
Primary outcome
Assess efficacy of honey as a disinfectant in comparison to the standard disinfectant which is alcohol
Time frame: 3 months
taking a swab from skin for culture of organisms after application of either alcohol or honey and compare type of organisms and number of colony forming units
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- BackgroundBreasted JH. (1930): The Edwin Smith papyrus: published in facsimile and hieroglyphic transliteration. Chicago: University of Chicago Press.
- Background: PubMed 31438910Wiemken TL. Skin antiseptics in healthcare facilities: is a targeted approach necessary? BMC Public Health. 2019 Aug 22;19(1):1158. doi: 10.1186/s12889-019-7507-5.
- Background: PubMed 11982440Gheldof N, Engeseth NJ. Antioxidant capacity of honeys from various floral sources based on the determination of oxygen radical absorbance capacity and inhibition of in vitro lipoprotein oxidation in human serum samples. J Agric Food Chem. 2002 May 8;50(10):3050-5. doi: 10.1021/jf0114637.
- Background: PubMed 32683466Hasyimi W, Widanarni W, Yuhana M. Growth Performance and Intestinal Microbiota Diversity in Pacific White Shrimp Litopenaeus vannamei Fed with a Probiotic Bacterium, Honey Prebiotic, and Synbiotic. Curr Microbiol. 2020 Oct;77(10):2982-2990. doi: 10.1007/s00284-020-02117-w. Epub 2020 Jul 18.
- Background: PubMed 12151613Held E, Mygind K, Wolff C, Gyntelberg F, Agner T. Prevention of work related skin problems: an intervention study in wet work employees. Occup Environ Med. 2002 Aug;59(8):556-61. doi: 10.1136/oem.59.8.556.
- Background: PubMed 25742878Jull AB, Cullum N, Dumville JC, Westby MJ, Deshpande S, Walker N. Honey as a topical treatment for wounds. Cochrane Database Syst Rev. 2015 Mar 6;2015(3):CD005083. doi: 10.1002/14651858.CD005083.pub4.
- Background: PubMed 24612472Majtan J. Honey: an immunomodulator in wound healing. Wound Repair Regen. 2014 Mar-Apr;22(2):187-92. doi: 10.1111/wrr.12117. Epub 2014 Feb 24.
- Background: PubMed 23569748Mandal MD, Mandal S. Honey: its medicinal property and antibacterial activity. Asian Pac J Trop Biomed. 2011 Apr;1(2):154-60. doi: 10.1016/S2221-1691(11)60016-6.
- Background: PubMed 24322878Christensen GJ, Bruggemann H. Bacterial skin commensals and their role as host guardians. Benef Microbes. 2014 Jun 1;5(2):201-15. doi: 10.3920/BM2012.0062.
- Background: PubMed 10869910Sato T, Miyata G. The nutraceutical benefit, part iii: honey. Nutrition. 2000 Jun;16(6):468-9. doi: 10.1016/s0899-9007(00)00271-9. No abstract available.
- Background: PubMed 16226847Trevisanato SI. Treatments for burns in the London Medical Papyrus show the first seven biblical plagues of Egypt are coherent with Santorini's volcanic fallout. Med Hypotheses. 2006;66(1):193-6. doi: 10.1016/j.mehy.2005.08.052. Epub 2005 Oct 14.
- Individual participant dataSharing planned: No
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.
mamdouh abdelmaksoud study director
Ain Shams University
yosra awad study director
Ain Shams University
maha ahmad study director
Ain Shams 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 Alcohol sterilization and Honey sterilization in people with Disinfectant Causing Toxic Effect, run by Ain Shams 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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 7 May 2025. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ahmed badr (00201093562378, abn777777@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess efficacy of honey as a disinfectant in comparison to the standard disinfectant which is alcohol (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05937412, which also lists 11 linked publications.
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 May 2025.