An interventional study of RL3014A - DP0421 and CO3014AZ in Healthy, sponsored by Pierre Fabre Dermo Cosmetique. Completed at 1 site in Poland. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by Pierre Fabre Dermo Cosmetique (part of Pierre Fabre) · Not applicable, Interventional, and Supportive care
The Laboratoires Pierre Fabre has on the market a product range of daily use mouthwash, all containing 0.05% of O-Cymen -5-ol, a broad-spectrum bactericide. From other mouth rinses (reference mouthwash) it is known that they have a clear effect on the microbial composition of the tongue and saliva samples. RL3014A - DP0421, is the product of the range with the most representative formula.
The aim of the study is to evaluate if the product RL3014A - DP0421 respects the buccal flora and does not show an undesired effect on the microbial equilibrium of the mouth.
This study is conducted as a monocentric, randomized, controlled and blinded-label study, in parallel groups.
Study population: Adults with healthy gum status included and randomized in 4 parallel groups:
Group 4 (Negative control group). Group with standardized hygiene only
4 visits are planned:
The maximal duration of subject's participation is 44 days from the selection visit (visit 1) to the end of the study.
Pierre Fabre Dermo Cosmetique is the lead sponsor of 59 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Selection
Criteria related to the population:
For woman of :
Criteria related to subject's health:
- considered "healthy subject" by the Investigator
Criteria related to subject's oral health:
Non-selection criteria
Criteria related to the population:
Criteria related to the medical history / teeth condition:
Criteria related to treatments and/or products:
Inclusion criteria
Criteria related to the population:
For woman of childbearing potential:
Criteria related to the teeth condition:
Criteria related to the products:
- Subject whose performed his/her last teeth brushing either the evening before the inclusion visit (if the inclusion visit is performed in the morning) or in the morning of the inclusion visit (if the inclusion visit is performed in the afternoon).
Non-inclusion criteria
Criteria related to the population:
Criteria related to the medical history / teeth condition:
Criteria related to treatments and/or products:
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
Other: RL3014A - DP0421 · Other: Standardized hygiene
Other: CO3014AZ · Other: Standardized hygiene
Other: CO3014AY · Other: Standardized hygiene
Other: Standardized hygiene
Tested product. 2 applications per day for 28 days of the tested mouthwash
Positive control product. 2 applications per day for 28 days of the positive control mouthwash
Reference product. 2 applications per day for 28 days of the reference mouthwash
standardized hygiene with a toothpaste and a soft toothbrush provided by the sponsor and used for 44 days 2 times a day
Microbiome evaluation of the back of the tongue
Tongue swab sampling (cotton-swab samples)
Time frame: Visit 2 (Day 0) and Visit 4 (Day 28)
Microbiome evaluation of the saliva
Liquid saliva sampling
Time frame: Visit 2 (Day 0) and Visit 4 (Day 28)
Proteomic analysis of saliva
Liquid saliva sampling
Time frame: Visit 2 (Day 0) and Visit 4 (Day28)
Plaque index (TQHIP) score
Clinical assessment of the plaque using the Turesky modification of the Quigley-Hein Index performed by the dentist (scale from 0 to 5)
Time frame: Visit 2 (Day 0), Visit 3 (Day 14) and Visit 4 (Day 28)
Modified Gingival index of Lobene
Clinical assessment of the gums state using the Modified Gingival Index of Lobene (GI) (scale from 0 to 4)
Time frame: Visit 2 (Day 0), Visit 3 (Day 14) and Visit 4 (Day 28)
Recording of adverse events
Adverse events occurrence will be determined by the subject spontaneous reporting, the investigator's non-leading questioning and his/her clinical evaluation
Time frame: From Visit 1 (Day 1) to Visit 4 (Day 28 or early termination)
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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