Evaluation of Efficacy and Safety of Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel in the Treatment of Acne Vulgaris

Acne Vulgaris Clinical Trial

— Estudo Epiduo  

Official title:

Evaluation of Efficacy and Safety of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in the Treatment of Acne Vulgaris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01149330
• Other study ID #: BR.10.001
• Status: Completed
• Phase: Phase 4
• First received: June 22, 2010
• Last updated: March 9, 2012
• Start date: July 2010
• Est. completion date: April 2011

Study information

• Verified date: March 2012
• Source: Galderma Brasil Ltda.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance AgencyBrazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to demonstrate the efficacy of Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel in the treatment of acne vulgaris. The safety will also be evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: April 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 35 Years

Eligibility

Inclusion Criteria:

• Male or female Subjects, aged 12 to 35 years inclusive, with moderate to severe facial acne vulgaris (described scale score of 3 or 4),

• Subjects with a minimum of 20 and a maximum of 50 Inflammatory Lesions (papules and pustules) on the face, excluding the nose,

• Subjects with a minimum of 30 and a maximum of 100 Non-Inflammatory Lesions (open comedones and closed comedones) on the face, excluding the nose,

• Female Subjects of childbearing potential with a negative urine pregnancy test at the Baseline visit and must practice a highly effective method of contraception during the study: oral/systemic [injectable, patch…] contraception (must have been on a stable dose for 3 months prior to study entry), Intrauterine Device, strict abstinence, condoms, diaphragms, sponge, spermicides or partner had a vasectomy,

• 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,

• 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,

• Subjects willing and capable of cooperating to the extend and degree required by the protocol.

Exclusion Criteria:

• Subjects who have participated in another investigational drug or device research study within 30 days of enrollment,

• Female Subjects who are pregnant, nursing or planning a pregnancy during the study,

• Subjects with more than 1 nodule or cyst on the face

• Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.),

• Subjects with known or suspected allergy to one of the investigational products (see package insert and/or investigator brochure),

• Subjects who have pathological conditions photosensitive porphyria, SLE, LED, solar polymorphous eruption, actinic prurigo, solar urticaria, etc.

• Subjects with a beard or other facial hair that might interfere with study assessments,

• Subjects who foresee intensive UV exposure during the study (mountain sports, UV radiation, sunbathing, etc...)

• Female subjects with a history of hormonal changes.

• Subjects with skin condition or disease requiring topical or systemic therapy, which interferes with the investigational product or that may directly affect the evaluation criteria:

• Topical treatment for acne in the past two weeks.

• Anti-inflammatory topic in the last two weeks.

• Use of topical corticosteroids on the face in the last four weeks.

• Anti-inflammatory systemic (hormonal or not) in the last four weeks.

• Use of systemic corticosteroids in the last four weeks.

• Systemic antibiotics in the last four weeks (excluding penicillins).

• Systemic retinoids in the last six months.

• Other systemic anti-acne the last four weeks.

• Anticonceptional oral used exclusively for the control of acne in the past six months.

• Cosmetic procedures such as facials, peels, exfoliation, extraction of comedones, application of LED, laser or pulsed light in the last two weeks.

• Cosmetic procedures such as PDT in the last four weeks.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Adapalene-BPO Gel
Apply 1 gram of the investigational drug every night on whole face.

Locations

Country	Name	City	State
Brazil	KOLderma Instituto de Pesquisa Clínica Ltda	Campinas	Sao Paulo
Brazil	Hospital De Clínicas - Universidade Federal do Paraná	Curitiba	Paraná
Brazil	Instituo da Pele	Goiania	Goias
Brazil	Instituto de Dermatologia e Estética do Brasil Ltda.	Rio de Janeiro
Brazil	Serviço de Dermatologia do Ambulatório Magalhães Neto do Complexo HUPES - Universidade Federal da Bahia	Salvador	Bahia
Brazil	Instituto de Assistência Médica ao Servidor Público Estadual	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Galderma Brasil Ltda.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy evaluation	Changing from Baseline in Total Lesion count (Non-Inflammatory and Inflammatory lesions) in Week 12.	Week 12	No
Secondary	Secondary efficacy evaluation	Changing from Baseline in Total Lesion count (Non-Inflammatory and Inflammatory lesions) in Week 1.	Week 1	No
Secondary	Secondary efficacy evaluation	Changing from Baseline in Total Lesion count (Non-Inflammatory and Inflammatory lesions) in Week 2.	Week 2	No
Secondary	Changing from Baseline in Total Lesion count (Non-Inflammatory and Inflammatory lesions) in Week 2. Secondary efficacy evaluation	Changing from Baseline in Total Lesion count (Non-Inflammatory and Inflammatory lesions) in Week 4.	Week 4	No
Secondary	Secondary efficacy evaluation	Changing from Baseline in Total Lesion count (Non-Inflammatory and Inflammatory lesions) in Week 8.	Week 8	No
Secondary	Secondary efficacy evaluation	Changing from Baseline in Total Lesion count (Non-Inflammatory and Inflammatory lesions) in Week 12.; Assessment of the severity of facial acne. Evaluation of global improvement at study completion. Assessment of improvement and patient satisfaction.	Week 12	No
Secondary	Safety evaluation	Local tolerability scores - Erythema, Scaling, Dryness, Stinging/Burning at each study visit.	Week 1	Yes
Secondary	Safety evaluation	Local tolerability scores - Erythema, Scaling, Dryness, Stinging/Burning at each study visit.	Week 2	Yes
Secondary	Safety evaluation	Local tolerability scores - Erythema, Scaling, Dryness, Stinging/Burning at each study visit.	Week 4	Yes
Secondary	Safety evaluation	Local tolerability scores - Erythema, Scaling, Dryness, Stinging/Burning at each study visit.	week 8	Yes
Secondary	Safety evaluation	Local tolerability scores - Erythema, Scaling, Dryness, Stinging/Burning at each study visit.	Week 12	Yes