NCT01016977: C0000-411

A Phase 4, Single-Blind, Randomized, Study to Compare the Tolerability and Efficacy of Tazorac Cream When Used in Combination With Either Duac Gel or Acanya Gel for the Treatment of Facial Acne Vulgaris

Completed Phase 4 Results posted Last updated 1 December 2016

What this trial tests

Phase 4 trial testing Clindamycin 1%/Benzoyl Peroxide 5% and 0.1% tazarotene in Acne Vulgaris in 40 participants. Completed in 1 April 2010.

Timeline

1 October 2009

Primary endpoint
1 April 2010

1 April 2010

Quick facts

Lead sponsor	Stiefel, a GSK Company
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	40
Start date	1 October 2009
Primary completion	1 April 2010
Estimated completion	1 April 2010

Drugs / interventions tested

• Clindamycin 1%/Benzoyl Peroxide 5% and 0.1% tazarotene — full drug profile →
• clindamycin phosphate 1.2%/benzoyl peroxide 2.5% and 0.1% tazarotene — full drug profile →

Conditions studied

• Acne Vulgaris — all drugs for Acne Vulgaris →

Sponsor

Stiefel, a GSK Company — full company profile →

Who can join

Adults 12 to 45, any sex, with Acne Vulgaris. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Mean Change From Baseline in Erythema at Weeks 1, 2, 4, 8, and 12
  Time frame: Baseline and Weeks 1, 2, 4, 8, and 12
  Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Erythema (redness of the skin, due to increased blood flow in the capillaries in the lower layers of theh skin) was assessed by the investigator based on a 6-point scale: 0=none, which is normal; 1=trace, which is mild and localized; 2=mild, which is mild and diffuse; 3=moderate,
• Mean Change From Baseline in Dryness at Weeks 1, 2, 4, 8, and 12
  Time frame: Baseline and Weeks 1, 2, 4, 8, and 12
  Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Dryness was assessed by the investigator based on a 6-point scale: 0=none, which is normal; 1=trace, which is mild and localized; 2=mild, which is mild and diffuse; 3=moderate, which is moderate and diffuse; 4=marked, which is moderate and dense; 5=severe, which is prominent and d
• Mean Change From Baseline in Peeling at Weeks 1, 2, 4, 8, and 12
  Time frame: Baseline and Weeks 1, 2, 4, 8, and 12
  Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Peeling was assessed by the investigator based on a 6-point scale: 0=none, which is normal; 1=trace, which is mild and localized; 2=mild, which is mild and diffuse; 3=moderate, which is moderate and diffuse; 4=marked, which is moderate and dense; 5=severe, which is prominent and d
• Mean Change From Baseline in Burning/Stinging at Weeks 1, 2, 4, 8, and 12
  Time frame: Baseline and Weeks 1, 2, 4, 8, and 12
  Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Burning/stinging was assessed by participants based on a 6-point scale: 0=none: normal, no discomfort; 1=trace: awareness, no discomfort, no intervention required; 2=mild: noticeable discomfort, intermittent awareness; 3=moderate: noticeable discomfort, continuous awareness; 4=mar
• Mean Change From Baseline in Itching at Weeks 1, 2, 4, 8, and 12
  Time frame: Baseline and Weeks 1, 2, 4, 8, and 12
  Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 6, 8, and 12 minus the value at baseline. Itching was assessed by participants based on a 6-point scale: 0=none: normal, no discomfort; 1=trace: awareness, no discomfort, no intervention required; 2=mild: noticeable discomfort, intermittent awareness; 3=moderate: noticeable discomfort, continuous awareness; 4=marked: d
• Mean Change From Baseline in Oiliness at Weeks 1, 2, 4, 8, and 12
  Time frame: Baseline and Weeks 1, 2, 4, 8, and 12
  Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Oiliness was assessed by participants based on a 6-point scale: 0=none: normal, no discomfort; 1=trace: awareness, no discomfort, no intervention required; 2=mild: noticeable discomfort, intermittent awareness; 3=moderate: noticeable discomfort, continuous awareness; 4=marked: def

Sponsor's own description

A single-blind (investigator-blinded), randomized, parallel group, single center study to evaluate the tolerability and efficacy of combination therapy with Duac Gel / 0.1% Tazorac Cream and Acanya Gel / 0.1% Tazorac Cream for the treatment of facial acne vulgaris.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Topical benzoyl peroxide for acne.
   Yang Z, Zhang Y, Lazic Mosler E, Hu J, et al · · 2020 · cited 29× · PMID 32175593 · DOI 10.1002/14651858.cd011154.pub2