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Clinical Trials/EUCTR2013-001753-26-FR
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

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.

Registry
who.int
Start Date
September 28, 2015
End Date
February 20, 2014
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Male

Investigators

Sponsor
Pierre Fabre Dermo-cosmétique

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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