EUCTR2013-001753-26-FR
Active, Not Recruiting
Phase 1
Clinical and biophysics evaluation of the cutaneous modifications following the local use of a lotion containing 0,1 % of trétinoïne.
Pierre Fabre Dermo-cosmétique0 sites24 target enrollmentSeptember 28, 2015
DrugsLOCACID 0.1% lotion
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Pierre Fabre Dermo-cosmétique
- Enrollment
- 24
- Status
- Active, Not Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Relative to the population:
- •O male Adult.
- •O Age included between 18 and 30 inclusive years.
- •O Phototype I to IV
- •o Pilosity reduced at the level of the top of the back
- •o Subject affiliated to a French national insurance scheme,
- •o Subject having given its written consent to its participation in the study.
- •O Registration in the national file of the persons who lend themselves to biomedical researches.
- •Relative to the pathology:
- •Subject having a moderated acne at the level of the back, the evaluation by the investigator global assessment of the acne (rank 1, 2, 3\)
Exclusion Criteria
- •Relative to the pathologies:
- •· Any dermatological pathology on the back, other than the acne.
- •· Existence of a chronic affection or an evolutionary acute pathology which can interfere with the study.
- •Relative to treatments:
- •· Use of a self\-tanning, keratolytic or exfoliating product on the back in 2 weeks preceding the inclusion.
- •· Use on the back of any product which can interfere with the study (produced moisturizer, care product) in 2 weeks preceding the inclusion.
- •· Treatment by oral route by antibiotics in 2 weeks preceding the inclusion.
- •· Treatment by oral route by anti\-inflammatory or corticoid during more than 2 consecutive days in 2 weeks preceding the inclusion.
- •\- Treatment by local use on the study zone : by anti\-inflammatory, corticoid or antibiotics during more than 2 consecutive days in 2 weeks preceding the inclusion.
- •· Hormonal treatment (in thyroid, anti\-acned) by oral route in two months preceding the inclusion.
Outcomes
Primary Outcomes
Not specified
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