A Study of the Safety and Efficacy of DFD-03 for the 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: | July 31, 2017 |
| End Date: | April 19, 2018 |
A Multicenter, Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled Study of the Safety and Efficacy of DFD-03 Lotion in the Treatment of Acne Vulgaris for 12 Weeks
Enrollment of subjects with mild to moderate facial acne. Subjects with acne lesions of any
severity on the chest and/or back (including shoulders) may be enrolled provided they have
mild to moderate acne on the face. During the 12-week treatment period subjects will use the
study product twice daily. Subjects will be instructed to treat the entire face (and chest
and/or back including shoulders, if applicable).
Efficacy will be assessed by using an Investigator's Global Assessment scale (IGA 5 point
scale) and by counting the number of inflammatory and non-inflammatory lesions on the face at
Baseline and Weeks 4, 8, and 12.
Safety assessments will include the investigator's assessment of local cutaneous tolerance of
the treated skin (dryness, non-lesional erythema, peeling, stinging, burning, and itching;
assessed separately on the chest and/or back including shoulders (if applicable), vital signs
(blood pressure and pulse rate), and adverse events (AEs). Urine pregnancy tests will be
performed at Baseline and at every visit through Week 12 for all female subjects. A physical
examination will be performed.
severity on the chest and/or back (including shoulders) may be enrolled provided they have
mild to moderate acne on the face. During the 12-week treatment period subjects will use the
study product twice daily. Subjects will be instructed to treat the entire face (and chest
and/or back including shoulders, if applicable).
Efficacy will be assessed by using an Investigator's Global Assessment scale (IGA 5 point
scale) and by counting the number of inflammatory and non-inflammatory lesions on the face at
Baseline and Weeks 4, 8, and 12.
Safety assessments will include the investigator's assessment of local cutaneous tolerance of
the treated skin (dryness, non-lesional erythema, peeling, stinging, burning, and itching;
assessed separately on the chest and/or back including shoulders (if applicable), vital signs
(blood pressure and pulse rate), and adverse events (AEs). Urine pregnancy tests will be
performed at Baseline and at every visit through Week 12 for all female subjects. A physical
examination will be performed.
Main Inclusion Criteria:
1. Subject must be at least 9 years of age.
2. A clinical diagnosis of mild to moderate facial acne vulgaris.
3. Inflammatory lesion count (papules and pustules) of at least 20 on the face,
Non-inflammatory lesion count (closed and open comedones) of at least 25 on the face
and No more than 2 nodulocystic lesions on the face.
4. Females, regardless of childbearing potential, if sexually active, must be on or use
an acceptable method of birth control.
5. Subject must be in good general health as determined by the investigator and supported
by medical history, physical and Vital Signs exam.
Main Exclusion Criteria:
1. Females who are pregnant or lactating or planning to become pregnant.
2. Treatment with the following products:
1. Topical acne treatments or other topical facial medication on the treatment area.
2. Systemic corticosteroids, systemic acne treatments including systemic antibiotics
used for treatment of acne.
3. Systemic retinoid use.
4. 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).
5. 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.
6. Treatment with an investigational product or device in the 30 days.
3. Known allergic reaction to retinoids or tazarotene.
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 in another investigational trial within 30 days.
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