Nail AbnormalitiesPhase 3NCT02582762
Pilot Study of Efficacy of Nail Gel in Finger Nail Surface Abnormality
A Phase 3 study testing Nail gel in people with Nail Abnormalities, run by Mahidol University at 1 site in Thailand.
Trial summary
Nail surface abnormalities is any conditions that affect the nail matrix or nail bed which cause nail plates grow defectively. Common nail surface abnormalities are pitting nails, longitudinal ridging, and transverse ridging/Beau's line. Aging nails usually have nail surface abnormalities as well. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nail Abnormalities
- What is being tested?
- Nail gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteThailand
- Study dates
- Sep 2015to Jun 2016
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years old or above
- Being diagnosed nail surface abnormalities stably more than 3 months
Who cannot join
- Having severe or uncontrolled concomitant diseases
- Having nail infection
- History of manicure within the last 1 month
- Use of Biotin or other nail modifying drugs within the previous 3 months
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Siriraj Hospital, Mahidol University
Bangkok, Bangkoknoi, 10700
Waranaree Winayanuwattikun, MD, 664194333, wara.mim@gmail.com
About this study
Official title: Pilot Study of Efficacy of Nail Gel Containing Artemisia Abrotanum Extract and Glycerin in Finger Nail Surface Abnormality
Nail surface abnormalities is any conditions that affect the nail matrix or nail bed which cause nail plates grow defectively. Common nail surface abnormalities are pitting nails, longitudinal ridging, and transverse ridging/Beau's line. Aging nails usually have nail surface abnormalities as well.
Nail gels are artificial nails used widely for aesthetic purposes. Although, their cosmetic use is increasing with day by day, their usefulness in conditions such as nail biting, brittle nails, and ingrown toe nails has been reported. Moreover, a previous study reported the benefits of nail gels in terms of improving nail surface abnormalities like pitting nails, trachyonychia, and onychoschizia.
This study was conducted to evaluate the efficacy of nail gel containing Glycerin which has humectant effect and Artemisia Abrotanum extract which has anti-fungal/bacterial activities in finger nail surface abnormalities.
Read the detailed description
Evaluation of nail surface abnormality can be done by using Visiometer® (bioengineering measurement) and dermoscope. Both techniques are non-invasive.
Artemisia Abrotanum extract has been used as ingredient in cosmetic products and its safety has been declared. Undesirable events from external using products containing this substance have never been reported yet. Nail gel product in this study has been approved as a cosmetic product by Food and Drug Administration of Thailand (Thai FDA).
- Conditions
- Nail Abnormalities
- Being tested
- Nail gel
- Keywords
- Nail gel, Nail surface abnormality, Efficacy
- Medical subject headings
- Nails, Malformed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nail gelDrug
Also called Locycare
apply nail gel on affected nails twice daily for 2 months
| Study group | Role | What they receive |
|---|---|---|
| Nail gel | Experimental | apply nail gel twice daily Receives: Drug: Nail gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement overall nail surface abnormalities
Number of nails of each participant with change/improvement nail surface using clinical assessment
Measured: 2 weeks and 8 weeks
Secondary outcomes (3)
Improvement roughness of nail surface abnormalities
Number of nails of each participant with change/improvement nail surface using bioengineering measurement
Measured: 2 weeks, and 8 weeks
Increase nail hydration
Number of nails of each participant with the increase of nail hydration using bioengineering measurement
Measured: 2 weeks, and 8 weeks
Patients's satisfaction
good patients's satisfaction outcome by self-questionnaire
Measured: 2 weeks and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study startSep 2015
- Primary completionMar 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nail AbnormalitiesStudies of the same condition, open and under way.
- More trials run by Mahidol 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sumanas Bunyaratavej, MD, Principal investigator, Siriraj Hospital, Mahiidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02582762
- Sponsor's protocol ID
- 658/2557(EC1)
- Status last verified
- Oct 2015
- First submitted
- 18 Oct 2015
- Last updated
- 21 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Efficacy of Nail Gel Containing Artemisia Abrotanum Extract and Glycerin in Finger Nail Surface Abnormality
- ClinicalTrials.gov ID
- NCT02582762
- Acronym / sponsor ID
- 658/2557(EC1)
- Conditions
- Nail Abnormalities
- Keywords
- Nail gel, Nail surface abnormality, Efficacy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 21 Oct 2015 (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.
Nail surface abnormalities is any conditions that affect the nail matrix or nail bed which cause nail plates grow defectively. Common nail surface abnormalities are pitting nails, longitudinal ridging, and transverse ridging/Beau's line. Aging nails usually have nail surface abnormalities as well.
Nail gels are artificial nails used widely for aesthetic purposes. Although, their cosmetic use is increasing with day by day, their usefulness in conditions such as nail biting, brittle nails, and ingrown toe nails has been reported. Moreover, a previous study reported the benefits of nail gels in terms of improving nail surface abnormalities like pitting nails, trachyonychia, and onychoschizia.
This study was conducted to evaluate the efficacy of nail gel containing Glycerin which has humectant effect and Artemisia Abrotanum extract which has anti-fungal/bacterial activities in finger nail surface abnormalities.
Detailed description
Evaluation of nail surface abnormality can be done by using Visiometer® (bioengineering measurement) and dermoscope. Both techniques are non-invasive.
Artemisia Abrotanum extract has been used as ingredient in cosmetic products and its safety has been declared. Undesirable events from external using products containing this substance have never been reported yet. Nail gel product in this study has been approved as a cosmetic product by Food and Drug Administration of Thailand (Thai FDA).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nail gel | Experimental | Drug: Nail gelapply nail gel twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 years old or above
- Being diagnosed nail surface abnormalities stably more than 3 months
Key exclusion criteria (5 listed)
- Having severe or uncontrolled concomitant diseases
- Having nail infection
- History of manicure within the last 1 month
- Use of Biotin or other nail modifying drugs within the previous 3 months
- Pregnancy or lactation
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 |
|---|---|---|
| Nail gelAlso: Locycareapply nail gel on affected nails twice daily for 2 months | Drug | Nail gel |
Primary outcome
Improvement overall nail surface abnormalities
Time frame: 2 weeks and 8 weeks
Number of nails of each participant with change/improvement nail surface using clinical assessment
3 secondary outcomes
Improvement roughness of nail surface abnormalities
Time frame: 2 weeks, and 8 weeks
Increase nail hydration
Time frame: 2 weeks, and 8 weeks
Patients's satisfaction
Time frame: 2 weeks and 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2015.
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.
Sumanas Bunyaratavej, MD principal investigator
Siriraj Hospital, Mahiidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nail gel in people with Nail Abnormalities, run by Mahidol University at 1 site in Thailand.
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 5 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 21 Oct 2015. 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 Thailand. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Sumanas Bunyaratavej, MD (6624194333, consultskin@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement overall nail surface abnormalities (time frame: 2 weeks and 8 weeks). 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 21 Oct 2015; AzTrials last refreshed its copy on 8 Nov 2026.