An interventional study of Sérum PURIFIANT and Sérum PURIFIANT in association Sérum BOOSTER in Onychomycosis, sponsored by Swiss Footcare Laboratories - Poderm Professional. Completed at 1 site in Mauritius. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-24.
Sponsored by Swiss Footcare Laboratories - Poderm Professional · Not applicable, Interventional, and Treatment
The goal of this clinical investigation is to evaluate the efficacy of the tested products in medium to moderate onychomycosis after 112 days of treatments.
The main question it aims to answer is the effectiveness of the use of a combination of two investigational devices (Sérum PURIFIANT + Sérum BOOSTER) on the percentage of healthy nail surface after 112 days of treatment.
Participants will apply one or two devices on the affected toenail during the study.
For this investigation, 44 patients (22 patients per group) presenting at least one infected toenail will be included to reach this objective.
Onychomycosis is a fungal infection of the nail apparatus that causes discoloration, thickening, and separation from the nail bed.
It is primarily caused by dermatophytes, which are infectious fungi that feed on the keratin present in the skin, hair and nails. Onychomycosis has several clinical presentations, including distal and lateral subungual onychomycosis which is the most common form, proximal subungual onychomycosis, superficial white onychomycosis, and total dystrophic onychomycosis.
Onychomycosis affects toenails more often than fingernails because of their slower growth, reduced blood supply, and frequent confinement in dark, moist environments. (1) The severity of onychomycosis can be described as mild, moderate, or severe. Published studies will assign a label of mild-moderate disease if less than approximately 60% of the nail is showing symptoms.
Onychomycosis is the most common nail infection worldwide occurring in 10% of the general population but is more common in older adults. Despite treatment, the recurrence rate of onychomycosis is 10% to 50% as a result of reinfection or lack of mycotic cure.
Topical drugs for onychomycosis generally come in the form of lacquers or solutions directly applied to the surface of the nail.
The principal aim of this study is to evaluate the efficacy of the tested products in medium to moderate onychomycosis after 112 days of treatments. For this study, 44 patients (22 patients per group) presenting at least one infected toenail will be included to reach this objective.
158 studies on the registry are indexed under Onychomycosis; 16 are open to participants now.
This study's enrollment of 44 is below the median of 60 across 143 interventional studies indexed under Onychomycosis.
Browse Onychomycosis studies →Swiss Footcare Laboratories - Poderm Professional is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participant will apply Sérum PURIFIANT on the affected toenail, twice daily during the 112 days of the study.
Device: Sérum PURIFIANT
Participant will apply Sérum PURIFIANT on the affected toenail, twice daily during the 112 days of the study. They will also apply Sérum BOOSTER, twice weekly before the Sérum PURIFIANT.
Device: Sérum PURIFIANT in association Sérum BOOSTER
Application of Sérum PURIFIANT only, twice daily during 112 days
Application of Sérum PURIFIANT twice daily during 112 days AND Application of Sérum BOOSTER before the Serum PURIFIANT, twice weekly
Percentage of healthy surface
The effect of the products on percentage of healthy surface will be evaluated at D112 by the mean variation from baseline in the group using a combination of two devices (Sérum PURIFIANT + Sérum BOOSTER). Evaluation is done in blind by digital analysis of photographs of the infected toenail.
Time frame: Day 0, Day 112
Percentage of healthy surface in group 1
The effect of the product on percentage of healthy surface will be evaluated at D112 by the mean variation from baseline in the group using only one device (Sérum PURIFIANT).
Time frame: Day 0, Day 112
Percentage of healthy surface comparison
The effect of the products on percentage of healthy surface will be evaluated at D112 by comparing mean variation from baseline between the two groups.
Time frame: Day 0, Day 112
Onychomycosis
The effect of the product on onychomycosis improvement will be evaluated at D0 and 112 days after treatment, on a scale from 0 normal to 3 severe. The effect of the products on clinical parameters will be evaluated by comparing mean variation from D0 within group and between the two groups.
Time frame: Day 0, Day 112
Onycholysis
The effect of the product on onycholysis improvement will be evaluated at D0 and 112 days after treatment, on a scale from 0 normal to 3 severe The effect of the products on clinical parameters will be evaluated by comparing mean variation from D0 within group and between the two groups.
Time frame: Day 0, Day 112
Nail microcacking
The effect of the product on nail microcacking improvement will be evaluated at D0 and 112 days after treatment. Number of nail microcracking will be collected. The effect of the products on clinical parameters will be evaluated by comparing mean variation from D0 within group and between the two groups.
Time frame: Day 0, Day 112
Nail opacity
The effect of the product on nail opacity improvement will be evaluated at D0 and 112 days after treatment, on a scale from 0 transparent to 4 Very opaque The effect of the products on clinical parameters will be evaluated by comparing mean variation from D0 within group and between the two groups.
Time frame: Day 0, Day 112
KOH staining
Percentage of patients with positive KOH staining at the screening visit and 112 days after treatment in each group and compared between the two groups.
Time frame: Day 0, Day 112
QoL
Percentage of patient with an improvement of their quality of life (QoL) by analysis of NailQoL patient answers at D0 and 112 days after treatment in each group and compared between the two groups.
Time frame: Day 0, Day 112
Patient questionnaire
Analysis of the answers to the patient questionnaire regarding effectiveness, tolerance, and acceptability of the investigational devices 112 days after treatment in each group. Answer will be on a scale from Totally agree to totally disagree
Time frame: Day 0, Day 112
Tolerance
Products tolerance will be assessed by the investigator and the patient at D112 on a 4 points scale from verry bad tolerance to very good tolerance
Time frame: Day 0, Day 112
Adverse event
Products safety will be assessed by collection of Adverse Events (AEs) throughout the study. AEs will be summarized and tabulated by severity, causality, action taken and outcome, using descriptive statistics.
Time frame: Screening visit, Day 0, Day 112
Plan to share: No
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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Swiss Footcare Laboratories - Poderm Professional