Evaluation of the cutaneous modifications following the local use of an anti acneic lotion.

Phase 1

• Conditions: Acne; MedDRA version: 18.0Level: HLTClassification code 10000497Term: AcnesSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; MedDRA version: 18.0Level: PTClassification code 10000496Term: AcneSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; MedDRA version: 18.0Level: SOCClassification code 10040785Term: Skin and subcutaneous tissue disordersSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; MedDRA version: 18.0Level: HLGTClassification code 10040798Term: Skin appendage conditionsSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2013-001753-26-FR
• Lead Sponsor: Pierre Fabre Dermo-cosmétique

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2014-02-20
• Study Start: 2015-09-28
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 24

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)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.
· Any anti-acned treatment:
O By local use on the study zone (acid azélaique, peroxide of benzoyle, antibiotics, rétinoïdes) in the month preceding the beginning of the study,
o By oral use: antibiotics (tétracyclines or macrolides) or zinc in the month preceding the beginning of the study,
o By oral use: rétinoïdes in 6 months preceding the beginning of the study.
· Allergy or for intolerance in one of the components of the LOCACID lotion ®.
· Histories known for allergy or intolerance to the latex.

Relative to the population:
· Exposure the back to the sun planned during the study.
· Presence on the experimental zone of solar erythema or other mark which can interfere with the evaluation of the cutaneous reactions (pigmentation disorders, tattoo).
· Participation in a clinical trial on the back in the week preceding the inclusion.
· Subject in the impossibility to conform to theprotocol requirements.
· Subject having perceived, within the framework of clinical trials, compensations superior to 4 500 euros, this included study, during the last 12 months.
· Subject in incapacity to understand the information (for linguistic or psychiatric causes) and to give its consent.
• Subject confiscated his liberty by administrative or legal decision or guardianship.
· Subject which participates at present or which participated in another clinical trial and being in period of exclusion during which he can not participate to another clinical trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified