A Study of the Safety and Efficacy of DFD-03 for the Treatment of Acne Vulgaris

NCT03290027 | Completed Phase 3 Results FDA Drug

• 1 other identifier: DFD-03-CD-005
• Study Type: interventional
• Target: 550
• Locations: 1 country
• Sites: 1

Brief Summary

Enrollment of subjects with mild to moderate facial acne. Efficacy was 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 included the investigator's assessment of local cutaneous tolerance of the treated skin (dryness, non-lesional erythema, peeling, stinging, burning, and itching, vital signs, and adverse events (AEs).

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (3)

• Absolute Change in the Inflammatory Lesion Counts on the Face

  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

  Baseline to Week 12

• Absolute Change in the Non-inflammatory Lesion Counts on the Face

  Change in non-inflammatory lesion counts on the face from baseline to Week 12 - will be analyzed using the same ANCOVA model

  Baseline to Week 12

• Proportion of Subjects With Treatment Success Based on IGA Score

  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

  Baseline to Week 12

Study Arms (2)

Active

EXPERIMENTAL

DFD-03 (0.1% tazarotene) Lotion

Drug: DFD-03

Vehicle

PLACEBO COMPARATOR

Vehicle (0% tazarotene) Lotion

Other: Placebo Comparator

Interventions

DFD-03 DRUG

DFD-03 Lotion

Also known as: Tazarotene 0.1% Lotion

Active

Placebo Comparator OTHER

Vehicle (tazarotene 0%) Lotion

Also known as: Vehicle

Vehicle

Eligibility Criteria

• Age: 9 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be at least 9 years of age.
• A clinical diagnosis of mild to moderate facial acne vulgaris.
• 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.
• Females, regardless of childbearing potential, if sexually active, must be on or use an acceptable method of birth control.
• Subject must be in good general health as determined by the investigator and supported by medical history, physical and Vital Signs exam.

You may not qualify if:

• Females who are pregnant or lactating or planning to become pregnant.
• Treatment with the following products:
• Topical acne treatments or other topical facial medication on the treatment area.
• Systemic corticosteroids, systemic acne treatments including systemic antibiotics used for treatment of acne.
• Systemic retinoid use.
• 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).
• 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 the 30 days.
• Known allergic reaction to retinoids or tazarotene.
• 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.
• 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.
• Subjects who have been in another investigational trial within 30 days.

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (1)

Dr. Seemal

Plano, Texas, 75024, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

tazarotene

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Results Point of Contact

• Title: Srinivas Sidgiddi
• Organization: Dr. Reddys Laboratories Inc.

srinivassidgiddi@drreddys.com

9084585362

Study Officials

• Srinivas Sidgiddi, M.D.

  Dr. Reddy's Laboratories Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2017
• First Posted: September 21, 2017
• Study Start: July 31, 2017
• Primary Completion: April 19, 2018
• Study Completion: April 19, 2018
• Last Updated: March 1, 2021
• Results First Posted: May 26, 2020

Record last verified: 2021-02

Locations

US (1)