A Study to Assess the Safety and Local Tolerability of DFD-03 (Tazarotene) Lotion, 0.1% Compared to Tazorac® (Tazarotene) Cream, 0.1% in the Topical Treatment of Acne Vulgaris



Status:Completed
Conditions:Acne, Acne, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:9 - Any
Updated:8/18/2018
Start Date:August 21, 2017
End Date:May 18, 2018

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A Randomized, Double-Blind, Active-Controlled Study to Assess the Safety and Local Tolerability of DFD-03 (Tazarotene) Lotion, 0.1% Compared to Tazorac® (Tazarotene) Cream, 0.1% in the Topical Treatment of Acne Vulgaris for 12 Weeks

A study for Subjects with mild to moderate facial acne vulgaris. Subjects will be randomized
to treatment with either DFD-03 (tazarotene) Lotion 0.1%, Tazorac (tazarotene) Cream, 0.1%,
Vehicle Lotion or Vehicle Cream. During the 12-week treatment period subjects randomized to
DFD-03 Lotion or Vehicle Lotion will use the study drug twice daily. Subjects randomized to
Tazorac Cream or Vehicle Cream will use the study drug once daily in the evening. Subjects
will be instructed to treat the entire face.

Safety assessments will include the investigator's assessment of local cutaneous
tolerance/application site reactions on the face, vital signs and adverse events. Urine
pregnancy tests will be performed for all female subjects. A physical examination will be
performed.


Inclusion Criteria:

1. Subject must be at least 12 years of age. At selected site(s), a total of
approximately eight subjects 9-11 years of age will be enrolled into the 2 arms of
DFD-03 lotion group (active and vehicle).

2. A clinical diagnosis of facial acne vulgaris with a facial Investigator's Global
Assessment (IGA) score of 2 (mild) to 3 (moderate) at Baseline. At selected site(s),
up to twelve subjects with acne lesions on the chest and/or back (including shoulders)
in addition to those on the face will treat their chest and/or back (including
shoulders) in addition to their face.

3. Inflammatory lesion count (papules and pustules) of at least 20, non-inflammatory
lesion count (closed and open comedones) of at least 25 on the face including the
nose, and no more than 2 nodulocystic lesions. This criteria is not applicable to the
9-11 years age group as long as subjects have an IGA score of 2 (mild) to 3 (moderate)
at Baseline.

4. Females, regardless of childbearing potential: Must have a negative urine pregnancy
test and if sexually active, must be on or use an acceptable method of birth control.

5. Subjects agree not to use any product on the face during the entire course of study
except for non-medicated, investigator-approved cleanser, sunscreen, face wash, and
make-up as instructed by the investigator.

6. Subjects must be willing to comply with sun avoidance measures for the face, including
use of investigator-approved sunscreen and/or hats, have limited sun exposure time,
and have no tanning bed use.

7. Subject must be in good general health as determined by the investigator and supported
by the medical history, physical examination and vital signs.

Exclusion Criteria:

1. Females who are pregnant or lactating or planning to become pregnant during the study
period.

2. Treatment with the following products:

Topical acne treatments or other topical facial medication in the 14 days prior to
Baseline Systemic corticosteroids and systemic acne treatments in the 30 days prior to
Baseline Systemic retinoid use in the 180 days prior to Baseline Undertaken certain
facial procedures such as chemical peel, laser treatment, photodynamic therapy, acne
surgery, cryodestruction or chemodestruction, x-ray therapy, intralesional steroids,
dermabrasion, or depilation (except eyebrow shaping) in 30 days prior to Baseline.

Treatment with a medication or procedure that, in the opinion of the investigator,
would put the subject at unacceptable risk for participation in the study or may
interfere with evaluations in the study.

Treatment with an investigational product or device in 30 days prior to Baseline.

3. Known allergic reaction to retinoids or tazarotene or any of the product ingredients.

4. Presence of any facial skin disease or condition that would interfere with the study
or place the subject at unacceptable risk including sunburn, rosacea, seborrheic
dermatitis, perioral dermatitis, lupus, dermatomyositis, psoriasis, eczema, squamous
cell carcinoma, acneiform eruptions caused by medications, steroid acne, steroid
folliculitis, bacterial folliculitis or any other facial disease or condition.

5. Subjects with a serious and or chronic medical condition such as chronic or active
liver disease, renal impairment, heart disease, severe respiratory disease, rheumatoid
arthritis, current malignancies, immunocompromised conditions, or any other disease
that, in the opinion of the investigator, would interfere with the study or place the
subject at unacceptable risk.

6. Subjects who have been treated for alcohol dependence or alcohol or drug abuse in the
year.
We found this trial at
1
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8370 West Flagler Street
Miami, Florida 33144
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Miami, FL
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