A Bioavailability Study of DFD-03 Compared to Tazorac® in Patients With Moderate Acne Vulgaris

NCT03599193 | Completed Phase 2 Results FDA Drug

• 1 other identifier: DFD-03-CD-007
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 2

Brief Summary

This was a multicenter, randomized, multiple-dose, laboratory-blinded, open-label, 2-arm, parallel-arm study in subjects with moderate acne vulgaris.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (3)

• Maximum Plasma Concentration (Cmax)

  The maximum plasma concentration of tazarotenic acid post dosing on Day 21 (Cmax(ss))

  Day 21

• Area Under the Curve (AUC0-24) at Steady State

  The Area Under the Curve time 0 to 24 hours (AUC0-24ss) of tazarotenic acid at steady state (Day 21)

  Day 21

• Number of Subjects With Treatment Emergent Adverse Events (TEAE)

  Number of subjects with at least one TEAE from the time of signing the consent until the end of the study (Approximately 21 days).

  Day 1 to Day 21

Secondary Outcomes (1)

• Time to Maximum Concentration (Tmax) of Tazarotenic Acid

  Day 21

Study Arms (2)

DFD-03 Lotion

EXPERIMENTAL

DFD-03 Lotion will be applied to the affected areas twice daily for 1 minute and rinsed off. 29 subjects will be enrolled into this arm.

Drug: Tazarotene Lotion, 0.1%

Tazorac Cream

ACTIVE COMPARATOR

Tazorac Cream will be applied to the affected areas once daily and left on for \~12 hours. 29 subjects will be enrolled into this arm.

Drug: Tazarotene Cream, 0.1%

Interventions

Tazarotene Lotion, 0.1% DRUG

DFD-03 (Tazarotene Lotion, 0.1%) applied Twice Daily for 1 minute and rinsed off

Also known as: DFD-03 Lotion

DFD-03 Lotion

Tazarotene Cream, 0.1% DRUG

Tazorac® (tazarotene) Cream, 0.1% applied Once Daily and left for approximately 12 hours

Also known as: Tazorac Cream

Tazorac Cream

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 understands the study procedures, is willing to comply with the study procedures and required visits, and agrees to participate by giving written informed consent. Subjects under the legal age of consent must provide written assent and must have the written informed consent of their legal guardian.
• Subject (or legal guardian) must be willing to authorize use and disclosure of protected health information collected for the study.
• Male or female at least 9 years of age for the DFD-03 (Test) group and at least 12 years of age for the Tazorac Cream (Reference) group.
• Female subjects must be having their menstrual period at Baseline (Day 1, 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.
• A clinical diagnosis of facial acne vulgaris with a facial Investigator's Global Assessment (IGA) score of 3 (moderate) at Baseline (Day 1).
• Subjects should have acne lesions on at least 1 of the following regions at the Screening visit: neck, upper chest, upper back (including shoulders).
• This criterion is not applicable to the 9-11 years and 11 months age group.
• Inflammatory lesion count (papules and pustules) of at least 20 on the face, including the nose, at Baseline (Day 1).
• This criterion is not applicable to the 9-11 years and 11 months age group.
• Non-inflammatory lesion count (closed and open comedones) of at least 25 on the face, including the nose, at Baseline (Day 1).
• This criterion is not applicable to the 9-11 years and 11 months age group.
• No more than 2 nodulocystic lesions on the face, including the nose, at Baseline (Day 1).
• Females, regardless of childbearing potential:
• Must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline (Day 1). Urine pregnancy test must have a sensitivity of at least 25 mIU/mL for βhCG.
• If sexually active, must be on or use an acceptable method of birth control. Acceptable methods of birth control include hormonal methods\* or intrauterine device in use ≥ 90 days prior to Baseline (Day 1); or partner has had a vasectomy at least 90 days prior to Baseline (Day 1); or barrier methods plus spermicide; or Essure® that has been in place for at least 3 months before the screening visit with radiograph confirmation of fallopian tube blockage.

You may not qualify if:

• Females who are pregnant or lactating or planning to become pregnant during the study period.
• Treatment with the following products:
• Topical acne treatments (other retinoids, antibiotics, benzoyl peroxide, azelaic acid, resorcinol, salicylates, α-hydroxy/glycolic acid), or other topical facial medication (antifungals, steroids, anti-inflammatories) on the treatment area in the 14 days prior to Baseline (Day 1), including prescription and non-prescription products.
• Systemic corticosteroids, systemic acne treatments including systemic antibiotics used for treatment of acne, potential photosensitizing agents (thiazides, phenothiazines), spironolactone, flutamide, or immunosuppressant drugs in the 30 days prior to Baseline (Day 1).
• Systemic retinoid use (including high-dose vitamin A \> 10,000 units per day) in the 180 days prior to Baseline (Day 1).
• 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 Baseline (Day 1). After the subject is enrolled in the study, eyebrow shaping (except for tweezing) is prohibited.
• 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 prior to Baseline (Day 1).
• Known allergic reaction to retinoids or tazarotene or any of the other ingredients of these products. The inactive ingredients are sodium lauryl sulphate, stearyl alcohol, cetyl alcohol, gluconolactone, Vitamin E polyethylene glycol succinate, glycerin, carbomer P 971, propylparaben, methylparaben, edetate disodium, butylated hydroxytoluene, medium-chain triglyceride, trolamine, and purified water.
• 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.
• Excessive facial hair (i.e., heavy beard or mustache), facial tattoos, or facial disfigurement, excessive hair on the neck, upper chest, shoulders and upper back region that would interfere with study assessments.
• 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 treated for alcohol dependence or alcohol or drug abuse in the year prior to Baseline (Day 1).
• Subjects who have been in another investigational trial within 30 days of Baseline (Day 1).
• Subjects may not have a personal relationship with any member of the study staff or be part of the staff at the medical practice.

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (2)

Dr. DuBois

Austin, Texas, 73301, United States

Location

Dr. Jones

Austin, Texas, 73301, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Srinivas Sidgiddi
• Organization: Dr. Reddy's Laboratories Inc.

srinivassidgiddi@drreddys.com

9084585362

Study Officials

• Anirudh Gautam

  Dr. Reddy's Laboratories Inc.

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Tazarotene and tazarotenic acid plasma concentrations will be determined at a designated laboratory from the blinded samples using a validated bioanalytical method.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2018
• First Posted: July 26, 2018
• Study Start: October 4, 2017
• Primary Completion: April 30, 2018
• Study Completion: April 30, 2018
• Last Updated: March 1, 2021
• Results First Posted: September 14, 2020

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)