Patient Education on Acne

Phase 1

• Conditions: Acne vulgaris; MedDRA version: 17.0 Level: SOC Classification code 10040785 Term: Skin and subcutaneous tissue disorders System Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2014-002509-39-GB
• Lead Sponsor: GALDERMA R&D

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-09-10
• Study Completion: 2015-06-08
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 97

Inclusion Criteria

1.Male or female subjects age of 12 years or older,
2.With facial acne vulgaris that can be managed in primary care,
3.Female subjects of childbearing potential with a negative urine pregnancy test (UPT) at Baseline visit,
4.Female subjects of childbearing potential must practice a highly effective method of contraception during the study: medical contraception (combined oral contraceptives [estrogens and progesterone] or implanted or injectable contraceptives with stable dose for at least 1 month prior to study entry), bilateral tubal ligation, hormonal intrauterine device (inserted at least 1 month prior to study entry), strict abstinence (at least 1 month prior to study entry and agree to continue for the duration of the study), or vasectomized partner (at least 3 months prior to study entry),
5.Females of non-childbearing potential, e.g., premenses, post-menopausal (absence of menstrual bleeding for 1 year prior to study entry), hysterectomy, or bilateral ovariectomy,
6.Subjects willing and capable of complying with the extent and degree required by the protocol,
7.Subjects or the parents/legal guardians (for subjects of 12-17 years old) understand and sign the Informed Consent Form (ICF) at Baseline, prior to any investigational procedure being performed.

Are the trial subjects under 18? yes
Number of subjects for this age range: 70
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Female subjects who are pregnant, nursing or planning a pregnancy during the study,
2.Subjects have acne on their chest and/or back,
3.Subjects have a very severe variant of acne such as fulminating acne with systemic symptoms (acne fulminans),
4.Subjects with severe acne or painful, deep nodules or cysts (nodulocystic acne),
5.Subjects with severe social or psychological problems including a morbid fear of deformity (dysmorphophobia),
6.Subjects are at risk of, or are developing, scarring despite primary care therapies,
7.Subjects have moderate acne that has failed to respond to treatment which should generally include several courses of both topical and systemic treatment over a period of at least 6 months,
8.Subjects are suspected of having an underlying endocrinological cause for the acne (such as polycystic ovary syndrome) that needs assessment,
9.Subjects currently taking any other acne treatments,
10.Subjects with known impaired hepatic or renal functions
11.Subjects with known intolerance to lactose,
12.Subjects with a condition or who are in a situation which, in the investigator’s opinion, may put the subject at risk, confound the study results, or interfere with the subject’s participation in the study,
13.Subjects who are at risk in terms of precautions, warnings, and contraindications (see package inserts),
14.Subjects with known or suspected allergies or sensitivities to any component of the study drug (see package inserts),
15.Subjects who have participated in another investigational drug or device research study within 30 days of enrolment of this study,
16.Subjects of 12-17 years for whom the signed ICF from their parents/legal guardians is not obtained,
17.Subjects under guardianship, hospitalised subjects in a public or private institution for a reason other than the research, and subjects deprived of their freedom

Study & Design

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