A Bioequivalence Study With Clinical Endpoints Comparing Adapalene and Benzoyl Peroxide Topical Gel 0.1%/2.5% (Actavis Mid-Atlantic LLC) To Epiduo™ (Adapalene and Benzoyl Peroxide) Gel 0.1%/2.5% (Galderma Laboratories, L.P.) in the Treatment of Mild to Severe Acne Vulgaris

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01501799
• Date of registration: 27/12/2011
• Prospective Registration: No
• Primary sponsor: Actavis Mid-Atlantic LLC
• Public title: A Bioequivalence Study With Clinical Endpoints Comparing Adapalene and Benzoyl Peroxide Topical Gel 0.1%/2.5% (Actavis Mid-Atlantic LLC) To Epiduo™ (Adapalene and Benzoyl Peroxide) Gel 0.1%/2.5% (Galderma Laboratories, L.P.) in the Treatment of Mild to Severe Acne Vulgaris
• Scientific title: A Multicenter, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Adapalene and Benzoyl Peroxide Topical Gel 0.1%/2.5% (Actavis Mid-Atlantic LLC) To Epiduo™ (Adapalene and Benzoyl Peroxide) Gel 0.1%/2.5% (Galderma Laboratories, L.P.) and Both Active Treatments to Topical Gel Placebo (Actavis Mid-Atlantic Llc) in the Treatment of Mild to Severe Acne Vulgaris
• Date of first enrolment: July 2011
• Target sample size: 885
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01501799
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Belize, India, United States

Contacts

• Name: Nagashayana G., M.D.
• Affiliation: Lotus Labs Pvt Ltd

• Name: Nermina Nakas, M.D., M.P.H.
• Affiliation: Jubilant Clinsys, Inc

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Male or nonpregnant female patients must be between the ages of 12 and 40 years old
inclusive.

2. Patients who are 18 years of age or older must have provided IEC/IRB approved written
informed consent. Patients between the ages of 12 to 17 years of age must have
provided IEC/IRB approved written assent; this written assent must be accompanied by
an IEC/IRB approved written informed consent from the patient's legally acceptable
representative (i.e., parent or guardian). In addition, all patients or their legally
acceptable representatives (i.e., parent or guardian) must sign a HIPAA
authorization, if applicable.

3. Patients must have a definite clinical diagnosis of mild to severe acne vulgaris
(Grade 2, Grade 3 or Grade 4 on the IGE).

4. Patients must have a minimum of 20 inflammatory lesions and a maximum of 100 and a
minimum of 25 and a maximum of 100 non-inflammatory lesions (i.e., open and closed
comedones) and no more than 2 nodulocystic lesions (i.e., nodules and cysts) at
baseline. For the purposes of study treatment and evaluation, these lesions should
be limited to the facial treatment area. Lesions involving the eyes, angles of the
nose (i.e., the lines around your nostrils and under the nostrils) and scalp should
be excluded from the count. Patients may have acne lesions on other areas of the body
(e.g., on the back).

5. Female patients of childbearing potential must have been using accepted methods of
birth control or must agree to continue to practice abstinence, from 30 days prior to
study entry to 30 days after the last administration of study drug. All female
patients are considered to be of childbearing potential unless they have been
surgically sterilized or have been postmenopausal for at least 1 year. Abstinence is
an acceptable method of birth control. Any of the following methods of birth control
are acceptable: oral contraceptives, contraceptive patches/implants (e.g., Norplant®)
Depo-Provera®, double barrier methods (e.g., condom and spermicide) or IUD. Female
patients must have a negative urine pregnancy test at baseline. A negative result of
a pregnancy test having a minimum sensitivity of at least 50 mIU/ml for hCG should be
obtained.

6. All male patients must agree to use accepted methods of birth control with their
partners, from the day of the first dose administration to 30 days after the last
administration of study drug. Abstinence is an acceptable method of birth control.
Any of the following methods of birth control are acceptable: oral contraceptives,
contraceptive patches/implants (e.g., Norplant®), Depo-Provera®, double barrier
methods (e.g., condom and spermicide) or IUD.

7. Patients must be willing and able to understand and comply with the requirements of
the protocol, including attendance at the required study visits.

8. Patients must be willing to refrain from using any other treatments for acne
vulgaris, including antibiotics, other than the investigational product, for acne
present on the face. Patients may use other topical acne treatments that do not have
significant or measurable systemic absorption for treatment of acne of the back,
shoulders and chest (e.g., benzoyl peroxide, salicylic acid).

9. Patients must be in good health and free from any clinically significant disease.

10. Patients who use make-up must have used the same brands/types of make-up for a
minimum period of 14 days prior to study entry and must agree to not change make-up
brand/type or frequency of use throughout the study.

Exclusion Criteria:

1. Female patients who are pregnant, nursing or planning to become pregnant during study
participation (Visit 1 through Visit 5) will be excluded from study participation.

2. Patients who have a known hypersensitivity to benzoyl peroxide, adapalene, and other
retinoids, or their excipients will be excluded from study participation.

3. Patients who have conditions that may interfere with the evaluation of acne vulgaris.
Such conditions include, but are not limited to the following lesions on the face:
rosacea; seborrheic dermatitis; perioral dermatitis; corticosteroid-induced acne or
folliculitis; carcinoid syndrome; squamous cell carcinoma; mastocytosis; acneiform
eruptions caused by make-up or medication; bacterial folliculitis; facial psoriasis;
and facial eczema.

4. Patients who have acne congoblata, acne fulminans, and secondary acne (e.g.,
chloracne and drug induced acne) will be excluded from participation.

5. Patients who have been treated with systemic antibiotics or systemic anti-acne drugs
or systemic anti-inflammatory drugs within 30 days prior to baseline will be excluded
from study participation.

6. Patients who have been treated with prescription and/or over-the-counter topical
medications for the treatment of acne vulgaris including antibiotics, topical
corticosteroids, a-hydroxy/glycolic acid, benzoyl peroxide, or topical
anti-inflammatory medications on the face within 14 days prior to baseline will be
excluded from study participation.

7. Patients who are currently taking or have been treated with systemic corticosteroids
(including intranasal and inhaled corticosteroids) within 30 days prior to baseline
will be excluded from study participation.

8. Patients who have started hormonal therapy or changed the dosage of their hormonal
therapy within 3 months prior to baseline will be excluded from study participation.
The dosage and frequency of use of any hormonal therapy started greater than 3 months
prior to baseline must remain unchanged throughout the study (Visit 1 through Visit
5). Hormonal treatments include, but are not limited to, estrogenic and
progestational agents such as birth control pills.

9. Patients who use androgen receptor blockers (such as spironolactone or flutamide)
will be excluded from study participation.

10. Patients who have received oral retinoids (e.g., isotretinoin) within 180 days prior
to study entry,or have used therapeutic vitamin A supplements of greater than 10,000
units/day (multivitamins are allowed) within 180 days prior to study entry, or have
applied topical retinoids (e.g., tretinoin, tazarotene, adapalene) to the face within
the 2 weeks prior to baseline will be excluded from study participation.

11. Patients who have received radiation therapy and/or anti-neoplastic agents within 90
days prior to baseline will be excluded from study participation.

12. Patients who have unstable medical disorders that are cli


Age minimum: 12 Years
Age maximum: 40 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Acne Vulgaris

Intervention(s)

Drug: EPIDUO

Drug: adapalene 0.1% and benzoyl peroxide 2.5% topical gel

Drug: Placebo (Vehicle Gel)

Primary Outcome(s)

Percent change in inflammatory and non-inflammatory lesions from Baseline to Week 12 [Time Frame: Week 12]

Treatment-emergent adverse events [Time Frame: 12 Weeks]

Signs and Symptoms of Local Irritation [Time Frame: 12 Weeks]

Secondary Outcome(s)

The proportion of "success" patients at Visit 5 using the IGE [Time Frame: 12 Weeks]

Mean Percent Change in Total Lesion Count from Baseline to Visit 5 [Time Frame: 12 Weeks]

Secondary ID(s)

ACTA/ADAP/BP/2010

Source(s) of Monetary Support

Please refer to primary and secondary sponsors