Ingrown ToenailPhase 4NCT01844141
Effectiveness of Lavage With Alcohol - Chlorhexidine for Chemical Matricectomy
A Phase 4 study testing 70% alcohol and 70% alcohol - 0.5% clorhexidine in people with Ingrown Toenail, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial summary
To compare the efficacy of the lavage with 70% alcohol plus 0.5% chlorhexidine versus 70% alcohol in the surgical treatment of ingrown toenails. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ingrown Toenail
- What is being tested?
- 70% alcohol and 70% alcohol - 0.5% clorhexidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2013to Apr 2013
- Phase
- Phase 4
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older than 18 with onychocryptosis
Who cannot join
- infection, history of tinea pedis, onychomycosis, paronychia, nail trauma or subungual hematoma, nail deformities and disorders, peripheral vascular disease or diabetes, cardiac disease, history of rheumatic fever, recent antibiotic use or current antimicrobial therapy, history of steroid use and recent nail polish use
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Universidad Complutense de Madrid (Podología)
Madrid, Madrid, 28040
Ricardo Berceo, PhD
About this study
Official title: Effectiveness of the Lavage With 70% Alcohol Plus 0.5% Chlorhexidine Compared to 70% Alcohol for Chemical Matricectomy in the Surgical Treatment of Ingrown Toenails
To compare the efficacy of the lavage with 70% alcohol plus 0.5% chlorhexidine versus 70% alcohol in the surgical treatment of ingrown toenails.
Read the detailed description
The purpose of this study is to compare the efficacy of the lavage with 70% alcohol plus 0.5% chlorhexidine versus 70% alcohol during the phenolization procedure in the surgical treatment of ingrown toenails in patients undergoing for chemical matricectomy.
- Conditions
- Ingrown Toenail
- Being tested
- 70% alcohol, 70% alcohol - 0.5% clorhexidine
- Keywords
- phenol, ingrown toenail, chemical matricectomy
- Medical subject headings
- Nails, Ingrown
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
70% alcoholDrug
Also called Isopropilic alcohol., Ethanol
After phenolization of the ingrown toenail the wound is irrigated with 15 cc solution of 70% alcohol plus 0.5% clorhexidine
70% alcohol - 0.5% clorhexidineDrug
Also called chlorhexidine-gluconate
In the intervention group five rounds of 3 ml wash of 70% alcohol - 0.5% clorhexidine was used to irrigate the exposed area of the nail to neutralize any residual effect of phenol and found out how much residual phenol is still in the wound.
| Study group | Role | What they receive |
|---|---|---|
| alcohol - clorhexidine | Experimental | Ingrown toenail irrigated using 70% alcohol - 0.5% clorhexidine Receives: Drug: 70% alcohol - 0.5% clorhexidine |
| 70% alcohol | Active comparator | Ingrown toenail irrigated using 70% alcohol Receives: Drug: 70% alcohol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantity of phenol recovered in each lavage with each solution
The amounts of phenol in the samples were quantified by a Jasco modular high performance liquid chromatograph HPLC (Jasco International Co Ltd, Japan) equipped with a LG-2080-04 quaternary low-gradient unit, a PU-2080 pump, a DG-2080-54 degasser, an AS-2050-plus autosampler and a UV-2070 plus UV/Vis detector was used. A C18 column Luna (particle size 3 µm, 150 x 4.6 mm) (Phenomenex, Torrance, CA, USA) was selected for the chromatographic separation of the components, adjusting the column temperature to 30 °C (LC Ni-II/ADC oven).
Measured: up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2013 (estimated)
- Study startJan 2013
- Primary completionApr 2013 (estimated)
- Study completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ingrown ToenailStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ricardo Becerro de Bengoa Vallejo, Universidad Complutense de Madrid
- Investigators
- Ricardo Becerro de Bengoa, Phd, Principal investigator, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01844141
- Sponsor's protocol ID
- RIC11022013
- Status last verified
- Apr 2013
- First submitted
- 11 Feb 2013
- Last updated
- 1 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Plusje LG. Pincer nails: a new surgical treatment. Dermatol Surg. 2001 Jan;27(1):41-3.
PubMed 11231241Baran R, Haneke E, Richert B. Pincer nails: definition and surgical treatment. Dermatol Surg. 2001 Mar;27(3):261-6.
PubMed 11277894Gao W, Legido-Quigley C. Fast and sensitive high performance liquid chromatography analysis of cosmetic creams for hydroquinone, phenol and six preservatives. J Chromatogr A. 2011 Jul 15;1218(28):4307-11. doi: 10.1016/j.chroma.2011.04.064. Epub 2011 May 6.
PubMed 21621212
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Lavage With 70% Alcohol Plus 0.5% Chlorhexidine Compared to 70% Alcohol for Chemical Matricectomy in the Surgical Treatment of Ingrown Toenails
- ClinicalTrials.gov ID
- NCT01844141
- Acronym / sponsor ID
- RIC11022013
- Conditions
- Ingrown Toenail
- Keywords
- phenol, ingrown toenail, chemical matricectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 1 May 2013 (estimated)
- 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.
To compare the efficacy of the lavage with 70% alcohol plus 0.5% chlorhexidine versus 70% alcohol in the surgical treatment of ingrown toenails.
Detailed description
The purpose of this study is to compare the efficacy of the lavage with 70% alcohol plus 0.5% chlorhexidine versus 70% alcohol during the phenolization procedure in the surgical treatment of ingrown toenails in patients undergoing for chemical matricectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| alcohol - clorhexidine | Experimental | Drug: 70% alcohol - 0.5% clorhexidineIngrown toenail irrigated using 70% alcohol - 0.5% clorhexidine |
| 70% alcohol | Active comparator | Drug: 70% alcoholIngrown toenail irrigated using 70% alcohol |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Older than 18 with onychocryptosis
Key exclusion criteria (1 listed)
- infection, history of tinea pedis, onychomycosis, paronychia, nail trauma or subungual hematoma, nail deformities and disorders, peripheral vascular disease or diabetes, cardiac disease, history of rheumatic fever, recent antibiotic use or current antimicrobial therapy, history of steroid use and recent nail polish use
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 |
|---|---|---|
| 70% alcoholAlso: Isopropilic alcohol., EthanolAfter phenolization of the ingrown toenail the wound is irrigated with 15 cc solution of 70% alcohol plus 0.5% clorhexidine | Drug | 70% alcohol |
| 70% alcohol - 0.5% clorhexidineAlso: chlorhexidine-gluconateIn the intervention group five rounds of 3 ml wash of 70% alcohol - 0.5% clorhexidine was used to irrigate the exposed area of the nail to neutralize any residual effect of phenol and found out how much residual phenol is still in the wound. | Drug | alcohol - clorhexidine |
Primary outcome
Quantity of phenol recovered in each lavage with each solution
Time frame: up to 2 weeks
The amounts of phenol in the samples were quantified by a Jasco modular high performance liquid chromatograph HPLC (Jasco International Co Ltd, Japan) equipped with a LG-2080-04 quaternary low-gradient unit, a PU-2080 pump, a DG-2080-54 degasser, an AS-2050-plus autosampler and a UV-2070 plus UV/Vis detector was used. A C18 column Luna (particle size 3 µm, 150 x 4.6 mm) (Phenomenex, Torrance, CA, USA) was selected for the chromatographic separation of the components, adjusting the column temperature to 30 °C (LC Ni-II/ADC oven).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2013.
- Background: PubMed 11231241Plusje LG. Pincer nails: a new surgical treatment. Dermatol Surg. 2001 Jan;27(1):41-3.
- Background: PubMed 11277894Baran R, Haneke E, Richert B. Pincer nails: definition and surgical treatment. Dermatol Surg. 2001 Mar;27(3):261-6.
- Results publication: PubMed 21621212Gao W, Legido-Quigley C. Fast and sensitive high performance liquid chromatography analysis of cosmetic creams for hydroquinone, phenol and six preservatives. J Chromatogr A. 2011 Jul 15;1218(28):4307-11. doi: 10.1016/j.chroma.2011.04.064. Epub 2011 May 6.
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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.
Ricardo Becerro de Bengoa, Phd principal investigator
Universidad Complutense de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 70% alcohol and 70% alcohol - 0.5% clorhexidine in people with Ingrown Toenail, run by Universidad Complutense de Madrid at 1 site in Spain.
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 1 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: status not confirmed, as of the sponsor's last update on 1 May 2013. 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 Spain. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ricardo Becerro de Bengoa Vallejo, PhD ((34)670678145, ribebeva@enf.ucm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantity of phenol recovered in each lavage with each solution (time frame: up to 2 weeks). 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 NCT01844141, which also lists 3 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 1 May 2013.