Acne MedDRA version: 18.0 Level: HLT Classification code 10000497 Term: Acnes System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 18.0 Level: PT Classification code 10000496 Term: Acne System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 18.0 Level: SOC Classification code 10040785 Term: Skin and subcutaneous tissue disorders System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 18.0 Level: HLG
Conditions
Interventions
Trade Name: LOCACID 0.1% lotion
Pharmaceutical Form: Cutaneous liquid
INN or Proposed INN: tretinoin
CAS Number: 302-79-4
Concentration unit: % (V/V) percent volume/volume
Concentration type: equal
Co
Sponsors
Pierre Fabre Dermo-cosmétique
Eligibility
Sex/Gender
Male
Inclusion 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) 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Measure the evolution on 21 days of the skin dryness consecutive to the local application of trétinoïne treatment compared with an untreated zone.;Secondary Objective: Measure by clinical, biometrological, spectroscopiques, biochemical, molecular and illustrative methods, some criterion associated to the skin dryness consecutive to the local application of a trétinoïne treatment.;Primary end point(s): SRRC score which measures the skin dryness at day 1 and day 22;Timepoint(s) of evaluation of this end point: day 1 and day 22 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Some criterion linked to the skin dryness.;Timepoint(s) of evaluation of this end point: Day 1, day 8, day 15, day 22 | — |
Countries
France
Contacts
Public ContactQUESTEL
Pierre Fabre Dermo-cosmétique
Outcome results
None listed