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Trial record 2 of 81 for:    acne AND almost AND facial

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 : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited

Tracking Information
First Submitted Date  ICMJE September 21, 2017
First Posted Date  ICMJE September 25, 2017
Last Update Posted Date October 8, 2019
Actual Study Start Date  ICMJE July 6, 2017
Actual Primary Completion Date May 14, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 22, 2018)
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: September 21, 2017)
  • The absolute change from Baseline to Week 12 in the inflammatory (papules and pustules) and non-inflammatory (open and closed comedones) lesion counts on the face [ Time Frame: Baseline to Week 12 ]
  • 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 ]
    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.
Change History Complete list of historical versions of study NCT03292640 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2018)
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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of the Safety and Efficacy of DFD-03 Lotion in the Treatment of Acne Vulgaris for 12 Weeks
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: DFD-03 Lotion (0.1% tazarotene)
    Intervention: Drug: DFD-03 (0.1% tazarotene) Lotion
  • Placebo Comparator: DFD-03 Vehicle (0% tazarotene)
    Intervention: Drug: DFD-03 (0% tazarotene) Lotion (Placebo)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 22, 2018)
547
Original Estimated Enrollment  ICMJE
 (submitted: September 21, 2017)
550
Actual Study Completion Date  ICMJE May 14, 2018
Actual Primary Completion Date May 14, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 9 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03292640
Other Study ID Numbers  ICMJE DFD-03-CD-006
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Reddy's Laboratories Limited
Study Sponsor  ICMJE Dr. Reddy's Laboratories Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Srinivas R. Sidgiddi, M.D. Dr. Reddy's Laboratories
PRS Account Dr. Reddy's Laboratories Limited
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP