Pigmentation Clinical Trial
Official title:
A Monocenter, Double Blind Controlled Study to Assess the Photo-protector Effect of a Topical Product E212657+SPF Compare to SPF Alone Under UVDL Exposure in Healthy Volunteers
To evaluate the photo-protector effect of BC_3 (E212657) formulated in SPF compared to SPF alone on UV Day Light induced pigmentation in healthy volunteers
Status | Recruiting |
Enrollment | 50 |
Est. completion date | June 29, 2021 |
Est. primary completion date | June 29, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 40 Years |
Eligibility | Inclusion Criteria: 1. Healthy female or male volunteer; 2. 18 to 40 years old; 3. uniform skin color all over on the investigational zones; 4. skin type III or IV according to the Fitzpatrick classification; 5. ITA° between 10° and 35° at screening and inclusion visit with an authorize delta of ± 2° between screening and inclusion visit (Individual Typologic Angle calculated value); 6. female of childbearing potential who are sexually actives using a reliable mean of contraception (for at least three month before the beginning of the study, and throughout the study); 7. Female of childbearing potential willing to undergo urine pregnancy test 8. informed about the study objectives and procedures, and able to understand them; 9. Able to stay on the prone position more than 2 hours. 10. willing and able to fulfill the study requirements and schedule. 11. All subjects will have to give their written informed consent. Exclusion Criteria: 1. Female in pregnancy (positive pregnancy-test performed before inclusion) or lactation or without effective contraception ; 2. having planned U.V. exposure of the investigational zones (sunlight or sunbeds) throughout the study; 3. having used sunbed or sun exposure of the investigational zones within the 3 months before inclusion; 4. having sunburn (erythema) on the back; 5. dermatological disorders affecting the investigational zones (presence of naevi, freckles, excess hair or uneven skin tones, vitiligo, photo-dermatological problems); 6. history of skin cancer; 7. history of abnormal response to sun; 8. presence of recent suntan (according to Investigator opinion) or photo-test marks; 9. history of allergy, hypersensitivity, or any serious reaction to any cosmetic product; 10. any concomitant medical condition that may interfere with the study conduct in the opinion of the investigator; 11. having used within the month before inclusion any systemic medication for more than 5 consecutive days (e.g. steroidal and non-steroidal anti-inflammatory drugs, insulin, antihistamines, antihypertensive, antibiotics -e.g. quinolone, tetracycline, thiazides, fluoroquinolones-), or any medication known to cause abnormal responses to U.V. exposure (e.g. vitamin A derivatives, psoralen, aminolevulinic acid derivatives, etc.), or having planned to use these medications during the study; 12. having used within the 3 months before inclusion any depigmenting / whitening or propigmenting topical treatments, or any systemic treatment that would interfere with the study assessments (anti-inflammatory drugs, corticoids, retinoids, hydroquinone, etc.); 13. unable to be contacted by phone in case of emergency; 14. having participated within the 30 days before inclusion or currently participating in another clinical study. 15. Deprived of liberty by adjunction or by official decision. |
Country | Name | City | State |
---|---|---|---|
Romania | CIDP Biotechnology | Bucharest |
Lead Sponsor | Collaborator |
---|---|
L'Oreal |
Romania,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Biophysical non-invasive assessment of skin color by using Chromameter | Delta E, ITA, Delta a | Change from baseline at Day 7 | |
Primary | Clinical investigator's assessment by clinical score | Visual scoring of pigmentation from 0 to 9 | Change from baseline at Day 7 | |
Secondary | Safety was assessed by recording Adverse Events, including cutaneous reactions (local intolerance) | Safety was assessed by recording Adverse Events, including cutaneous reactions (local intolerance) | Change from baseline at Day 7 |
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