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Trial record 28 of 141 for:    acne AND erythema

A Study of the Safety and Efficacy of DFD-03 Lotion in the Treatment of Acne Vulgaris for 12 Weeks

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ClinicalTrials.gov Identifier: NCT03292640
Recruitment Status : Completed
First Posted : September 25, 2017
Last Update Posted : August 16, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited

Brief Summary:

Enrollment of subjects with mild to moderate facial acne vulgaris. 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 with approximately 12 hours between applications. Subjects will be instructed to treat the entire face (and chest/back including shoulders, if applicable).

Co-Primary efficacy endpoints include:

  • Absolute change from Baseline to Week 12 in the inflammatory lesion counts on the face
  • Absolute change from Baseline to Week 12 in the non-inflammatory lesion counts on the face
  • Proportion of subjects with a clinical response of "success" at Week 12 for lesions on the face. Success based on IGA is defined as an IGA score of 0 (Clear) or 1 (Almost clear) at Week 12 with at least a 2-grade reduction from Baseline.

The primary safety endpoint will be treatment-emergent adverse events (TEAEs). Other safety variables include local cutaneous tolerance evaluation (dryness, non-lesional erythema, peeling, stinging, burning, and itching) and vital signs (blood pressure and pulse rate). 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 at the Baseline Visit.


Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: DFD-03 (0.1% tazarotene) Lotion Drug: DFD-03 (0% tazarotene) Lotion (Placebo) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 547 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 6, 2017
Actual Primary Completion Date : May 14, 2018
Actual Study Completion Date : May 14, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne
Drug Information available for: Tazarotene

Arm Intervention/treatment
Experimental: DFD-03 Lotion (0.1% tazarotene) Drug: DFD-03 (0.1% tazarotene) Lotion
Subjects will apply a quarter (U.S coin) size amount of the study product all over the moistened face and rub it into the skin until foamy. Care should be taken to avoid the areas around the eyes, mouth, and nostrils. After a short time, the subject will rinse off the product by thoroughly rinsing with warm water. This procedure will be followed twice daily, in the morning and at bedtime, approximately 12 hours apart.

Placebo Comparator: DFD-03 Vehicle (0% tazarotene) Drug: DFD-03 (0% tazarotene) Lotion (Placebo)
Subjects will apply a quarter (U.S coin) size amount of the study product all over the moistened face and rub it into the skin until foamy. Care should be taken to avoid the areas around the eyes, mouth, and nostrils. After a short time, the subject will rinse off the product by thoroughly rinsing with warm water. This procedure will be followed twice daily, in the morning and at bedtime, approximately 12 hours apart.




Primary Outcome Measures :
  1. Absolute change in the inflammatory lesion counts on the face [ Time Frame: Baseline to Week 12 ]
    Change in inflammatory lesion counts on the face from baseline to Week 12 - will be analyzed using a two way analysis of covariance (ANCOVA) model

  2. Proportion of subjects with a clinical response of "success" at Week 12 for lesions on the face based on IGA. [ Time Frame: Baseline to Week 12 ]
    IGA success at Week 12 (an IGA score of 0 (Clear) or 1 (almost clear) with at least a 2-grade reduction from baseline) - will be analyzed using the Cochran-Mantel-Haenszel (CMH) test for general association

  3. Absolute change in the non-inflammatory lesion counts on the face [ Time Frame: Baseline to Week 12 ]
    Change in non-inflammatory lesion counts on the face from baseline to Week 12 - will be analyzed using the ANCOVA model


Secondary Outcome Measures :
  1. Percent change in inflammatory and non-inflammatory lesion counts on the face [ Time Frame: Baseline to Week 12 ]
    The percent change from Baseline to Week 12 in inflammatory and non-inflammatory lesion counts on the face will be analyzed using a two-way analysis of covariance (ANCOVA) model



Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject must be at least 9 years of age.
  2. Female subjects must be having their period at the Baseline Visit (as reported by the subject), except for subjects using hormonal contraceptives that preclude menstrual periods, if the subject is premenarcheal, is postmenopausal for at least 12 months prior to baseline, is surgically sterilized (i.e. tubal ligation) or if the subject is without a uterus and /or both ovaries.
  3. A clinical diagnosis of facial mild to moderate acne vulgaris. Subjects with acne lesions on the chest and/or back (including shoulders) in addition to those on the face have the option of treating their back and/or chest (including shoulders) in addition to their face.
  4. Inflammatory lesion count (papules and pustules) of at least 20 on the face, and 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 on the face, including the nose.
  5. 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.

  6. Subjects must be willing to comply with sun avoidance measures for the face (as well as back/chest and shoulders, if applicable) 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 normal or not clinically significant abnormal vital signs (blood pressure and pulse).

Exclusion Criteria:

  1. Females who are pregnant or lactating or planning to become pregnant during the study period.
  2. Treatment with the following products:

    1. Topical acne treatments or other topical facial medication on the treatment area in the 14 days prior to the Baseline Visit, including prescription and non-prescription products.
    2. Systemic corticosteroids, systemic acne treatments including systemic antibiotics used for treatment of acne, potential photosensitizing agents spironolactone, flutamide, or immunosuppressant drugs in the 30 days prior to the Baseline Visit.
    3. Systemic retinoid use in the 180 days prior to the Baseline Visit.
    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) in the 30 days prior to the Baseline Visit. After the subject is enrolled in the study, eyebrow shaping (except for tweezing) is prohibited.
    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 prior to the Baseline Visit.
  3. Known allergic reaction to retinoids or tazarotene or any of the other ingredients of these products.
  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.

7. Subjects who have been treated for alcohol dependence or alcohol or drug abuse in the year.

8. Subjects who have been in another investigational trial within 30 days.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03292640


Locations
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United States, California
Center for Dermatology Clinical Research Inc.
Fremont, California, United States, 94538
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
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Study Director: Srinivas R. Sidgiddi, M.D. Dr. Reddy's Laboratories

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Responsible Party: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT03292640     History of Changes
Other Study ID Numbers: DFD-03-CD-006
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: August 16, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Tazarotene
Nicotinic Acids
Dermatologic Agents
Keratolytic Agents
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs