Moderate to severe acne vulgaris on the face MedDRA version: 9.1 Level: LLT Classification code 10000519 Term: Acne vulgaris
Conditions
Interventions
Trade Name: Tetralysal® 300mg capsules
Product Name: Tetralysal
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: LYMECYCLINE
CAS Number: 992212
Concentration unit: mg milligram(s)
Concentration
Sponsors
Galderma Research & Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Male or female Subjects of any race, aged 12 to 35 years inclusive, 2.Subjects with moderate to severe facial acne vulgaris (Investigator’s Global Assessment score of 3 or 4), 3.Subjects with a minimum of 20 Inflammatory Lesions (papules and pustules) on the face, excluding the nose, 4.Subjects with a minimum of 30 and a maximum of 120 Non-Inflammatory Lesions (open comedones and closed comedones) on the face, excluding the nose, 5.Females of childbearing potential with a negative urine pregnancy test (UPT) and using a combination of a highly effective method of contraception (“method of first choice”) combined with a “method of second choice” (condom for the man, diaphragm, cervical cap with spermicide) for the whole duration of the study. A highly effective method of contraception is defined as : strict abstinence; combined oral contraceptives (estrogens and progesterone), implanted or injectable contraceptives, both on a stable dose for at least 3 months prior to study entry; hormonal intra-uterine device (IUD) inserted since at least 1 month; partner has been vasectomised for at least 3 months prior to study entry, 6.Females of non-childbearing potential, i.e., premenses, post-menopausal (absence of menstrual bleeding for 2 years), hysterectomy, bilateral tubal ligation, or bilateral ovariectomy, secondary infertility and sterility are not required to have a UPT at the beginning of the study, 7.Subjects have to read and sign the approved the Informed Consent form prior to any participation in the study. Subjects under the majority must sign an assent-to-participate form to participate in the study and they must have one parent or guardian read and sign the Informed Consent form prior to any study related procedure, 8.Subjects willing and capable of cooperating to the extend and degree required by the protocol. Are the trial subjects under 18? yes 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range ;Inclusion criteria: 1.Male or female Subjects of any race, aged 12 to 35 years inclusive, 2.Subjects with moderate to severe facial acne vulgaris (Investigator’s Global Assessment score of 3 or 4), 3.Subjects with a minimum of 20 Inflammatory Lesions (papules and pustules) on the face, excluding the nose, 4.Subjects with a minimum of 30 and a maximum of 120 Non-Inflammatory Lesions (open comedones and closed comedones) on the face, excluding the nose, 5.Females of childbearing potential with a negative urine pregnancy test (UPT) and using a combination of a highly effective method of contraception (“method of first choice”) combined with a “method of second choice” (condom for the man, diaphragm, cervical cap with spermicide) for the whole duration of the study. A highly effective method of contraception is defined as : strict abstinence; combined oral contraceptives (estrogens and progesterone), implanted or injectable contraceptives, both on a stable dose for at least 3 months prior to study entry; hormonal intra-uterine device (IUD) inserted since at least 1 month; partner has been vasectomised for at least 3 months prior to study entry, 6.Females of non-childbearing potential, i.e., premenses, post-menopausal (absence of menstrual bleeding for 2 years), hysterectomy, bilateral tubal ligation, or bilateral ovariectomy, secondary infertility and sterility are not required to have a UPT at the beginning of the study, 7.Subjects have to read and sign the approved the Informed Consent form prior to any participation in the study. Subjects under the majority must sign an assent-to-participate form to participate in the study and they must have one parent or guardian read and sign the Informed Consent form prior to any study related procedure, 8.Subjects willing and capable of cooperating to the extend and degree required by the protocol. Are the trial subjects under 18? yes 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Subjects with more than 3 nodules or cysts on the face 2.Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), 3.Female Subjects who are pregnant, nursing or planning a pregnancy during the study, 4.Subjects with a wash-out period for topical treatment on the face less than (see table below): •Corticosteroids, antibiotics, antibacterials, antiseptics, retinoids, other anti-inflammatory drugs or other acne treatments 2 weeks •Zinc containing drugs 1 week •Phototherapy devices for acne and cosmetic procedures (e.g., facials, peels, comedone extraction) 1 week 5.Subjects with a wash-out period for systemic treatment less than (see table below): •Acne therapy containing zinc 4 weeks •Corticosteroids, antibiotics 4 weeks •Other acne treatments (including isotretinoin and hormonal contraceptives solely for control of acne) 6 months •Ciproterone acetate / Chlormadinone acetate 6 months •Spironolactone / Drospirenone 3 months 6.Subjects with impaired hepatic (ALT/AST > 3xULN and bilirubin > 1.5xULN) or renal (creatinine clearance greater than 60 ml/min) functions based on a blood sample, 7.Subjects with known intolerance to lactose. 8.Subjects with a condition or who are in a situation which, in the Investigator’s opinion, may put the Subject at risk (e.g. history of significant renal disease with impairment of renal function), may confound the study results, or may interfere with the Subject’s participation in the study, 9.Subjects who are at risk in terms of precautions, warnings, and contraindications (see package insert and/or Investigator brochure), 10.Subjects with known or suspected allergy to one of the investigational products (see package insert and/or investigator brochure), 11.Subjects who have participated in another investigational drug or device research study within 30 days of enrollment, 12.Subjects with a beard or other facial hair that might interfere with study assessments, 13.Adult Subjects under guardianship, hospitalised Subjects in a public or private institution for a reason other than the Research, and Subjects deprived of their freedom. 14.Subjects who foresee intensive UV exposure during the study (mountain sports, UV radiation, sunbathing, etc...). ;Exclusion criteria: 1.Subjects with more than 3 nodules or cysts on the face 2.Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), 3.Female Subjects who are pregnant, nursing or planning a pregnancy during the study, 4.Subjects with a wash-out period for topical treatment on the face less than (see table below): •Corticosteroids, antibiotics, antibacterials, antiseptics, retinoids, other anti-inflammatory drugs or other acne treatments 2 weeks •Zinc containing drugs 1 week •Phototherapy devices for acne and cosmetic procedures (e.g., facials, peels, comedone extraction) 1 week 5.Subjects with a wash-out period for systemic treatment less than (see table below): •Acne therapy containing zinc 4 weeks •Corticosteroids, antibiotics 4 weeks •Other acne treatments (including isotretinoin and hormonal contraceptives solely for control of acne) 6 months •Ciproterone acetate / Chlormadinone acetate 6 months •Spironolactone / Drospirenone 3 months 6.Subjects with impaired hepatic (ALT/AST > 3xULN and bilirubin > 1.5xULN) or renal (creatinine clearance greater than 60 ml/min) functions based on a blood sample, 7.Subjects with known intolerance to lactose. 8.Subjects with a condition or who are in a situation which, in the Investigator’s opinion, may put the Subject at risk (e.g. history of significant renal disease with impairment of renal function), may confound the study results, or may interfere with the Subject’s participation in the study, 9.Subjects who are at risk in terms of precautions, warnings, and contraindications (see package insert and/or Investigator brochure), 10.Subjects with known or suspected allergy to one of the investigational products (see package insert and/or investigator brochure), 11.Subjects who have participated in another investigational drug or device research study within 30 days of enrollment, 12.Subjects with a beard or other facial hair that might interfere with study assessments, 13.Adult Subjects under guardianship, hospitalised Subjects in a public or private institution for a reason other than the Research, and Subjects deprived of their freedom. 14.Subjects who foresee intensive UV exposure during the study (mountain sports, UV radiation, sunbathing, etc...).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Lymecycline 300mg Capsules compared to Adapalene 0.1% /Benzoyl Peroxide 2.5% Vehicle Gel associated with Lymecycline 300mg Capsules, in the treatment of moderate to severe acne vulgaris.;Secondary Objective: The safety of the two treatment regimens will also be evaluated.;Primary end point(s): The primary objective of this study will be to demonstrate a superiority of Adapalene-BPO Gel associated with Lymecycline compared to its Vehicle Gel associated with Lymecycline, in terms of percent change in Total Lesion counts at Week 12 (LOCF). ;Main Objective: The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Lymecycline 300mg Capsules compared to Adapalene 0.1% /Benzoyl Peroxide 2.5% Vehicle Gel associated with Lymecycline 300mg Capsules, in the treatment of moderate to severe acne vulgaris.;Secondary Objective: The safety of the two treatment regimens will also be evaluated.;Primary end point(s): The primary objective of this study will be to demonstrate a superiority of Adapalene-BPO Gel associated with Lymecycline compared to its Vehicle Gel associated with Lymecycline, in terms of percent change in Total Lesion counts at Week 12 (LOCF). | — |
Countries
France, Germany, Italy, Sweden
Contacts
Public Contact; ;
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Outcome results
None listed