Trial Outcomes & Findings for A Bioavailability Study of DFD-03 Compared to Tazorac® in Patients With Moderate Acne Vulgaris (NCT NCT03599193)

NCT ID: NCT03599193

Last Updated: 2021-03-01

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 58 participants
• Primary outcome timeframe: Day 21
• Results posted on: 2021-03-01

Participant Flow

Participant milestones

Measure	DFD-03 Lotion DFD-03 Lotion was applied to the affected areas twice daily for 1 minute and rinsed off.	Tazorac Cream Tazorac Cream was applied to the affected areas once daily and left on for \~12 hours.
Overall Study STARTED	34	24
Overall Study COMPLETED	32	21
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Measure	DFD-03 Lotion DFD-03 Lotion was applied to the affected areas twice daily for 1 minute and rinsed off.	Tazorac Cream Tazorac Cream was applied to the affected areas once daily and left on for \~12 hours.
Overall Study Adverse Event	0	2
Overall Study Withdrawal by Subject	1	0
Overall Study Protocol Violation	1	0
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	DFD-03 Lotion n=34 Participants DFD-03 Lotion were applied to the affected areas twice daily for 1 minute and rinsed off. Thirty four (34) subjects were enrolled into this arm, of whom 32 completed the study. Tazarotene Lotion, 0.1%: DFD-03 (Tazarotene Lotion, 0.1%) applied Twice Daily for 1 minute and rinsed off	Tazorac Cream n=24 Participants Tazorac Cream were applied to the affected areas once daily and left on for \~12 hours. Twenty four (24) subjects were enrolled into this arm, of whom 21 completed the study. Tazarotene Cream, 0.1%: Tazorac® (tazarotene) Cream, 0.1% applied Once Daily and left for approximately 12 hours	Total n=58 Participants Total of all reporting groups
Age, Continuous	17 years STANDARD_DEVIATION 7 • n=5 Participants	18 years STANDARD_DEVIATION 5 • n=7 Participants	18 years STANDARD_DEVIATION 6 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	12 Participants n=7 Participants	28 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	12 Participants n=7 Participants	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 Participants n=5 Participants	19 Participants n=7 Participants	46 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants	16 Participants n=7 Participants	39 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	34 participants n=5 Participants	24 participants n=7 Participants	58 participants n=5 Participants
Body Mass Index (BMI)	23.0 Kilograms per meter square STANDARD_DEVIATION 4.4 • n=5 Participants	28.1 Kilograms per meter square STANDARD_DEVIATION 7.5 • n=7 Participants	25.1 Kilograms per meter square STANDARD_DEVIATION 6.4 • n=5 Participants

PRIMARY outcome

Timeframe: Day 21

Population: The Pharmacokinetic (PK) population included subjects who provided PK samples at all pre-specified time points.

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

Outcome measures

Measure	DFD-03 Lotion n=32 Participants DFD-03 Lotion was applied to the affected areas twice daily for 1 minute and rinsed off. Thirty four (34) subjects were enrolled into this arm, of whom 32 completed the study. Tazarotene Lotion, 0.1%: DFD-03 (Tazarotene Lotion, 0.1%) applied Twice Daily for 1 minute and rinsed off	Tazorac Cream n=21 Participants Tazorac Cream was applied to the affected areas once daily and left on for \~12 hours. Twenty four (24) subjects were enrolled into this arm and 21 subjects completed the study. Tazarotene Cream, 0.1%: Tazorac® (tazarotene) Cream, 0.1% applied Once Daily and left for approximately 12 hours
Maximum Plasma Concentration (Cmax)	180.78 pg/mL Standard Deviation 50.0	529.91 pg/mL Standard Deviation 40.2

PRIMARY outcome

Timeframe: Day 21

Population: The PK population included subjects who provided PK samples on Day 14 and Day 21.

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

Outcome measures

Measure	DFD-03 Lotion n=32 Participants DFD-03 Lotion was applied to the affected areas twice daily for 1 minute and rinsed off. Thirty four (34) subjects were enrolled into this arm, of whom 32 completed the study. Tazarotene Lotion, 0.1%: DFD-03 (Tazarotene Lotion, 0.1%) applied Twice Daily for 1 minute and rinsed off	Tazorac Cream n=21 Participants Tazorac Cream was applied to the affected areas once daily and left on for \~12 hours. Twenty four (24) subjects were enrolled into this arm and 21 subjects completed the study. Tazarotene Cream, 0.1%: Tazorac® (tazarotene) Cream, 0.1% applied Once Daily and left for approximately 12 hours
Area Under the Curve (AUC0-24) at Steady State	4644.16 pg.hr/mL Standard Deviation 43.6	8180.19 pg.hr/mL Standard Deviation 38.6

PRIMARY outcome

Timeframe: Day 1 to Day 21

Population: The Safety Population included all subjects randomized who provided at least one post baseline safety assessment.

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

Outcome measures

Measure	DFD-03 Lotion n=34 Participants DFD-03 Lotion was applied to the affected areas twice daily for 1 minute and rinsed off. Thirty four (34) subjects were enrolled into this arm, of whom 32 completed the study. Tazarotene Lotion, 0.1%: DFD-03 (Tazarotene Lotion, 0.1%) applied Twice Daily for 1 minute and rinsed off	Tazorac Cream n=24 Participants Tazorac Cream was applied to the affected areas once daily and left on for \~12 hours. Twenty four (24) subjects were enrolled into this arm and 21 subjects completed the study. Tazarotene Cream, 0.1%: Tazorac® (tazarotene) Cream, 0.1% applied Once Daily and left for approximately 12 hours
Number of Subjects With Treatment Emergent Adverse Events (TEAE)	34 Participants	23 Participants

SECONDARY outcome

Timeframe: Day 21

Population: The PK population included all subjects who provided PK samples at all pre-specified time-points.

Time to maximum concentration (Tmax(ss)) of tazarotenic acid at steady state (Day 21)

Outcome measures

Measure	DFD-03 Lotion n=32 Participants DFD-03 Lotion was applied to the affected areas twice daily for 1 minute and rinsed off. Thirty four (34) subjects were enrolled into this arm, of whom 32 completed the study. Tazarotene Lotion, 0.1%: DFD-03 (Tazarotene Lotion, 0.1%) applied Twice Daily for 1 minute and rinsed off	Tazorac Cream n=21 Participants Tazorac Cream was applied to the affected areas once daily and left on for \~12 hours. Twenty four (24) subjects were enrolled into this arm and 21 subjects completed the study. Tazarotene Cream, 0.1%: Tazorac® (tazarotene) Cream, 0.1% applied Once Daily and left for approximately 12 hours
Time to Maximum Concentration (Tmax) of Tazarotenic Acid	4.02 hours Interval 3.85 to 8.1	5.95 hours Interval 4.0 to 8.1

Adverse Events

DFD-03 Lotion

Serious events: 0 serious events

Other events: 34 other events

Deaths: 0 deaths

Tazorac Cream

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	DFD-03 Lotion n=34 participants at risk DFD-03 Lotion was applied to the affected areas twice daily for 1 minute and rinsed off. Thirty four (34) subjects were enrolled into this arm, of whom 32 completed the study. Tazarotene Lotion, 0.1%: DFD-03 (Tazarotene Lotion, 0.1%) applied Twice Daily for 1 minute and rinsed off	Tazorac Cream n=24 participants at risk Tazorac Cream was applied to the affected areas once daily and left on for \~12 hours. Twenty four (24) subjects were enrolled into this arm and 21 subjects completed the study. Tazarotene Cream, 0.1%: Tazorac® (tazarotene) Cream, 0.1% applied Once Daily and left for approximately 12 hours
General disorders Application site erythema	97.1% 33/34 • From the time of study consent until end of treatment or treatment discontinuation (Approximately 21 days). Adverse event data were collected from the time the Informed Consent Form was signed until study product treatment was discontinued, except for spontaneously reported SAEs, which were to be reported up to 30 days after discontinuing study product use.	87.5% 21/24 • From the time of study consent until end of treatment or treatment discontinuation (Approximately 21 days). Adverse event data were collected from the time the Informed Consent Form was signed until study product treatment was discontinued, except for spontaneously reported SAEs, which were to be reported up to 30 days after discontinuing study product use.
General disorders Application site exfoliation	100.0% 34/34 • From the time of study consent until end of treatment or treatment discontinuation (Approximately 21 days). Adverse event data were collected from the time the Informed Consent Form was signed until study product treatment was discontinued, except for spontaneously reported SAEs, which were to be reported up to 30 days after discontinuing study product use.	95.8% 23/24 • From the time of study consent until end of treatment or treatment discontinuation (Approximately 21 days). Adverse event data were collected from the time the Informed Consent Form was signed until study product treatment was discontinued, except for spontaneously reported SAEs, which were to be reported up to 30 days after discontinuing study product use.
General disorders Application site dryness	100.0% 34/34 • From the time of study consent until end of treatment or treatment discontinuation (Approximately 21 days). Adverse event data were collected from the time the Informed Consent Form was signed until study product treatment was discontinued, except for spontaneously reported SAEs, which were to be reported up to 30 days after discontinuing study product use.	91.7% 22/24 • From the time of study consent until end of treatment or treatment discontinuation (Approximately 21 days). Adverse event data were collected from the time the Informed Consent Form was signed until study product treatment was discontinued, except for spontaneously reported SAEs, which were to be reported up to 30 days after discontinuing study product use.
General disorders Application site pain	73.5% 25/34 • From the time of study consent until end of treatment or treatment discontinuation (Approximately 21 days). Adverse event data were collected from the time the Informed Consent Form was signed until study product treatment was discontinued, except for spontaneously reported SAEs, which were to be reported up to 30 days after discontinuing study product use.	79.2% 19/24 • From the time of study consent until end of treatment or treatment discontinuation (Approximately 21 days). Adverse event data were collected from the time the Informed Consent Form was signed until study product treatment was discontinued, except for spontaneously reported SAEs, which were to be reported up to 30 days after discontinuing study product use.
General disorders Application site pruritus	73.5% 25/34 • From the time of study consent until end of treatment or treatment discontinuation (Approximately 21 days). Adverse event data were collected from the time the Informed Consent Form was signed until study product treatment was discontinued, except for spontaneously reported SAEs, which were to be reported up to 30 days after discontinuing study product use.	70.8% 17/24 • From the time of study consent until end of treatment or treatment discontinuation (Approximately 21 days). Adverse event data were collected from the time the Informed Consent Form was signed until study product treatment was discontinued, except for spontaneously reported SAEs, which were to be reported up to 30 days after discontinuing study product use.
Skin and subcutaneous tissue disorders Eczema Asteatotic	14.7% 5/34 • From the time of study consent until end of treatment or treatment discontinuation (Approximately 21 days). Adverse event data were collected from the time the Informed Consent Form was signed until study product treatment was discontinued, except for spontaneously reported SAEs, which were to be reported up to 30 days after discontinuing study product use.	0.00% 0/24 • From the time of study consent until end of treatment or treatment discontinuation (Approximately 21 days). Adverse event data were collected from the time the Informed Consent Form was signed until study product treatment was discontinued, except for spontaneously reported SAEs, which were to be reported up to 30 days after discontinuing study product use.
Skin and subcutaneous tissue disorders Eczema	5.9% 2/34 • From the time of study consent until end of treatment or treatment discontinuation (Approximately 21 days). Adverse event data were collected from the time the Informed Consent Form was signed until study product treatment was discontinued, except for spontaneously reported SAEs, which were to be reported up to 30 days after discontinuing study product use.	4.2% 1/24 • From the time of study consent until end of treatment or treatment discontinuation (Approximately 21 days). Adverse event data were collected from the time the Informed Consent Form was signed until study product treatment was discontinued, except for spontaneously reported SAEs, which were to be reported up to 30 days after discontinuing study product use.
Nervous system disorders Headache	2.9% 1/34 • From the time of study consent until end of treatment or treatment discontinuation (Approximately 21 days). Adverse event data were collected from the time the Informed Consent Form was signed until study product treatment was discontinued, except for spontaneously reported SAEs, which were to be reported up to 30 days after discontinuing study product use.	8.3% 2/24 • From the time of study consent until end of treatment or treatment discontinuation (Approximately 21 days). Adverse event data were collected from the time the Informed Consent Form was signed until study product treatment was discontinued, except for spontaneously reported SAEs, which were to be reported up to 30 days after discontinuing study product use.

Additional Information

Dr. Srinivas Sidgiddi

Dr. Reddy's Laboratories Inc.

Phone: 9084585362

Email: srinivassidgiddi@drreddys.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place