| Eligibility |
Inclusion Criteria:
1. Criteria related to the population:
- Male or female, from 20 to 45 years old included.
- Phototype I, II or III according to the Fitzpatrick classification.
- Subject smoking = 10 cigarettes / day containing nicotine, paper and/or
electronic cigarette equivalent.
- Subject agreeing not to expose his forearms to UV (natural or artificial)
throughout the duration of the study and up to 3 months after the end of
participation in the study.
- If the subject is a woman of childbearing age:
i. Subject who used an effective method of contraception, evaluated by the
investigator for at least 8 weeks before inclusion in the study.
ii. Subject agreeing to continue using it during all the study and up to 5 days after
the last products application, in order to avoid pregnancy during exposure to the
study products.
- Absence from participation in a clinical research protocol.
- Signature of the informed consent form.
- Affiliation to social security scheme or beneficiary of such a scheme.
2. Criteria related to treatment:
- Subject protected by a tetanus vaccination according to the vaccination schedule
established by the Public Health Agency.
Exclusion Criteria:
1. Criteria related to the population:
- Pregnancy or breastfeeding ongoing or planned during the study.
- Subject deprived of freedom through a legal or administrative decision, or in
care or under legal guardianship.
- Subject unable to comply with the requirements of the protocol according to the
opinion of the investigator.
- Physical or linguistic impairment for signing the informed consent form.
- Current participation planned participation or participation in previous weeks or
months in another clinical study that may interfere with the study according to
the opinion of the investigator.
- Subject who has participated twice in a clinical study using the Er YAG laser on
the forearms.
2. Criteria related to diseases and general health:
- Subject with known immunodeficiency.
- Subject with known acquired immunodeficiency syndrome.
- Subject with known infectious hepatitis or a known history of hepatitis B or C.
- Subject with a known history of allergy or contact dermatitis induced in
particular by the latex, the plaster, the local anesthetic, the local antiseptic
or one of the components of the study products.
- Subject with a recognized addiction to alcoholism or drug.
- Subject having already presented cicatrization disorders.
- Subject presenting pathology of cicatrization or pathology with consequences on
cicatrization such as diabetes.
- Subject with a disease including skin disease in progress on the upper limbs that
may interfere with the interpretation of the evaluation criteria according to the
opinion of the investigator.
- Subject with a history of atopic eczema on the upper limbs (arms, forearms,
hands).
- Subject with skin lesion, solar erythema, tanning marks, scar(s), tattoo(s),
significant hair growth, nevus, visible or prominent veins on study areas that
may interfere with the interpretation of the evaluation criteria according to the
opinion of the investigator.
- Subject presenting hereditary disorders or acquired haemostasis.
- Subject with congenital methemoglobinemia or porphyria.
- Subject with chronic or acute pathology able to interfere with the results of the
study according to the opinion of the investigator.
3. Criteria related to treatments
- Diuretic or diuretic systemic treatment initiated or modified in the 2 months
prior to the inclusion visit or started at the inclusion visit or whose start is
scheduled during the study.
- Treatment liable to induce methemoglobinemia (sulfonamides, dapsone,
metoclopramide, flutamide, sodium nitroprusside) in the 14 days prior to the
inclusion visit or during the inclusion visit.
- Systemic corticosteroid treatment in the 14 days prior to the inclusion visit or
ongoing during the inclusion visit or planned during the study.
- Systemic treatment that may affect haemostasis, including anti-coagulant,
antiplatelet therapy, within 7 days prior to the inclusion visit or ongoing at
the inclusion visit or planned during the study.
- Systemic treatment with non-steroidal anti-inflammatory drug in the 7 days prior
to the inclusion visit or ongoing at the inclusion visit (from 3 days of intake).
- Systemic treatment liable to affect the healing process according to the opinion
of the investigator in the weeks prior to the inclusion visit, ongoing at the
inclusion visit or planned during the study.
- Systemic or topical antibiotic and/or antifungal treatment within 4 weeks prior
to the inclusion visit or ongoing at the inclusion visit.
- Topical antiseptic treatment applied to the upper limbs (including the hands)
within 2 weeks prior to the inclusion visit or ongoing at the inclusion visit.
- Topical non-steroidal anti-inflammatory treatment, topical corticosteroids,
immunomodulators applied to the upper limbs (including the hands) in the 15 days
prior to the inclusion visit or ongoing at the inclusion visit or planned during
the study.
- Physical treatment including forearm radiotherapy on the forearm in the 6 months
prior to the inclusion visit or ongoing at the inclusion visit or planned during
the study.
- Phototherapy treatment on the forearm in the 8 weeks prior to the inclusion
visit, ongoing at the inclusion visit or planned during the study.
- Subject with intense and prolonged exposure to UV (natural or artificial) in the
forearms in the 2 weeks prior to the inclusion visit or planned during the study.
- Any other treatments taken, applied or modified in the weeks prior to the
inclusion visit, ongoing at the inclusion visit or planned during the study that
may interfere with the study according to the opinion of the investigator.
- Use of keratolytic, exfoliating or self-tanning products on the upper limbs
(including hands) in the 14 days prior to the inclusion visit or on the day of
the inclusion visit.
- Use of a skin care product on the upper limbs (including the hands) in the 7 days
prior to the inclusion visit or the day of the inclusion visit.
- Application of water, hygiene products on the upper limbs in the 8 hours prior to
the inclusion visit, without hygiene usual routine modification during the study.
- Subject having modified his usual body hygiene routine the day before the
inclusion visit or planned to modify during the study.
|
