Trial Outcomes & Findings for Combination Therapy With Differin® Gel 0.3% and Duac® (Clindamycin/Benzoyl Peroxide Gel) in Subjects With Acne Vulgaris (NCT NCT00671749)

NCT ID: NCT00671749

Last Updated: 2022-08-23

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 100 participants
• Primary outcome timeframe: 6 and 12 weeks
• Results posted on: 2022-08-23

Participant Flow

Participant milestones

Measure	Combination Therapy Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
Overall Study STARTED	100
Overall Study COMPLETED	92
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Measure	Combination Therapy Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
Overall Study Adverse Event	2
Overall Study Withdrawal by Subject	4
Overall Study Protocol Violation	1
Overall Study Lost to Follow-up	1

Baseline Characteristics

Combination Therapy With Differin® Gel 0.3% and Duac® (Clindamycin/Benzoyl Peroxide Gel) in Subjects With Acne Vulgaris

Baseline characteristics by cohort

Measure	Combination Therapy n=100 Participants Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
Age, Continuous	18.2 years STANDARD_DEVIATION 5.40 • n=5 Participants
Sex: Female, Male Female	56 Participants n=5 Participants
Sex: Female, Male Male	44 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants
Race (NIH/OMB) White	77 Participants n=5 Participants
Race (NIH/OMB) More than one race	10 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	93 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Duration of Acne	4.0 years STANDARD_DEVIATION 3.91 • n=5 Participants
Fitzpatrick Skin Type I	1 participants n=5 Participants
Fitzpatrick Skin Type II	27 participants n=5 Participants
Fitzpatrick Skin Type III	38 participants n=5 Participants
Fitzpatrick Skin Type IV	22 participants n=5 Participants
Fitzpatrick Skin Type V	4 participants n=5 Participants
Fitzpatrick Skin Type VI	8 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 and 12 weeks

Outcome measures

Measure	Combination Therapy n=100 Participants Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
Percent Change From Baseline in Total Lesion Counts Week 6	-47 Percent Change Standard Deviation 24.43
Percent Change From Baseline in Total Lesion Counts Week 12	-64 Percent Change Standard Deviation 24.07

SECONDARY outcome

Timeframe: 6 and 12 weeks

Global Severity was assessed on a 6 point scale (Clear, Almost Clear, Mild, Moderate, Severe). The scale was dichotomized to success or failure where success = Clear or Almost Clear

Outcome measures

Measure	Combination Therapy n=100 Participants Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
Global Severity Assessment Success Week 6	8 participants
Global Severity Assessment Success Week 12	42 participants

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Measure	Combination Therapy n=100 Participants Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
Global Assessment of Improvement From Baseline Clear	3 participants
Global Assessment of Improvement From Baseline Almost Clear	40 participants
Global Assessment of Improvement From Baseline Marked Improvement	27 participants
Global Assessment of Improvement From Baseline Moderate Improvement	16 participants
Global Assessment of Improvement From Baseline Minimal Improvement	5 participants
Global Assessment of Improvement From Baseline No Change	8 participants
Global Assessment of Improvement From Baseline Worse	1 participants

SECONDARY outcome

Timeframe: 12 weeks

Population: Safety Population (n=99)

Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.

Outcome measures

Measure	Combination Therapy n=99 Participants Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
Worst Post Baseline Tolerability Assessment - Erythema None	29 participants
Worst Post Baseline Tolerability Assessment - Erythema Mild	37 participants
Worst Post Baseline Tolerability Assessment - Erythema Moderate	33 participants
Worst Post Baseline Tolerability Assessment - Erythema Severe	0 participants

SECONDARY outcome

Timeframe: 12 weeks

Population: Safety Population (n=99)

Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.

Outcome measures

Measure	Combination Therapy n=99 Participants Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
Worst Post Baseline Tolerability Assessment - Scaling None	53 participants
Worst Post Baseline Tolerability Assessment - Scaling Mild	27 participants
Worst Post Baseline Tolerability Assessment - Scaling Moderate	16 participants
Worst Post Baseline Tolerability Assessment - Scaling Severe	3 participants

SECONDARY outcome

Timeframe: 12 weeks

Population: Safety Population (n=99)

Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.

Outcome measures

Measure	Combination Therapy n=99 Participants Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
Worst Post Baseline Tolerability Assessment - Dryness None	49 participants
Worst Post Baseline Tolerability Assessment - Dryness Mild	27 participants
Worst Post Baseline Tolerability Assessment - Dryness Moderate	20 participants
Worst Post Baseline Tolerability Assessment - Dryness Severe	3 participants

SECONDARY outcome

Timeframe: 12 weeks

Population: Safety Population (n=99)

Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.

Outcome measures

Measure	Combination Therapy n=99 Participants Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
Worst Post Baseline Tolerability Assessment - Burning/Stinging None	67 participants
Worst Post Baseline Tolerability Assessment - Burning/Stinging Mild	18 participants
Worst Post Baseline Tolerability Assessment - Burning/Stinging Moderate	9 participants
Worst Post Baseline Tolerability Assessment - Burning/Stinging Severe	5 participants

Adverse Events

Combination Therapy

Serious events: 0 serious events

Other events: 32 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Combination Therapy n=99 participants at risk Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
General disorders Application Site Burn	32.3% 32/99 • 12 Weeks Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.
General disorders Application Site Dryness	24.2% 24/99 • 12 Weeks Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.
General disorders Application Site Erythema	10.1% 10/99 • 12 Weeks Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.
General disorders Application Site Exfoliation	7.1% 7/99 • 12 Weeks Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.
General disorders Application Site Discomfort	6.1% 6/99 • 12 Weeks Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.

Additional Information

Elizabeth M Nieman

Galderma Laboratories, L.P.

Phone: 817-961-5000

Email: elizabeth.nieman@galderma.com

Results disclosure agreements

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

Restriction type: GT60