A Phase 4 interventional study of adapalene gel, 0.3% and clindamycin/benzoyl peroxide gel in Acne Vulgaris, sponsored by Galderma R&D. Completed at 4 sites in United States. Open to participants aged 12 Years to 35 Years. Per ClinicalTrials.gov, last updated 2022-08-23.
Sponsored by Galderma R&D · Phase 4, Interventional, and Treatment
This study is to determine the efficacy and safety of 12 week treatment with Differin® Gel 0.3% applied in the evening, in combination with Duac® (Clindamycin/Benzoyl Peroxide Gel) applied in the morning, in Subjects with Acne vulgaris.
Same as above.
730 studies on the registry are indexed under Acne Vulgaris; 86 are open to participants now.
This study's enrollment of 100 is above the median of 69 across 628 interventional studies indexed under Acne Vulgaris.
Browse Acne Vulgaris studies →Galderma R&D is the lead sponsor of 280 studies on the registry; 9 are open to participants now.
Of its 59 completed or terminated interventional studies of FDA-regulated products, 55 (93%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
adapalene gel, 0.3% Other Names: Differin® Gel, 0.3% Applied once daily at bedtime clindamycin/benzoyl peroxide gel Other Names: Duac® Gel Applied once daily in the morning
Drug: adapalene gel, 0.3% · Drug: clindamycin/benzoyl peroxide gel
Applied once daily at bedtime
Also known as: Differin® Gel, 0.3%
Applied once daily in the morning
Also known as: Duac® Gel
Percent Change From Baseline in Total Lesion Counts
Time frame: 6 and 12 weeks
Global Severity Assessment Success
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
Time frame: 6 and 12 weeks
Global Assessment of Improvement From Baseline
Time frame: 12 weeks
Worst Post Baseline Tolerability Assessment - Erythema
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.
Time frame: 12 weeks
Worst Post Baseline Tolerability Assessment - Scaling
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.
Time frame: 12 weeks
Worst Post Baseline Tolerability Assessment - Dryness
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.
Time frame: 12 weeks
Worst Post Baseline Tolerability Assessment - Burning/Stinging
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.
Time frame: 12 weeks
| Milestone | Combination Therapy |
|---|---|
| Started | 100 |
| Completed | 92 |
| Not completed | 8 |
| Withdrew: Adverse event | 2 |
| Withdrew: Withdrawal by subject | 4 |
| Withdrew: Protocol violation | 1 |
| Withdrew: Lost to follow-up | 1 |
| Percent Change | Combination Therapy |
|---|---|
| Week 6 | -47 ± 24.43 |
| Week 12 | -64 ± 24.07 |
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
| participants | Combination Therapy |
|---|---|
| Week 6 | 8 |
| Week 12 | 42 |
| participants | Combination Therapy |
|---|---|
| Clear | 3 |
| Almost Clear | 40 |
| Marked Improvement | 27 |
| Moderate Improvement | 16 |
| Minimal Improvement | 5 |
| No Change | 8 |
| Worse | 1 |
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.
| participants | Combination Therapy |
|---|---|
| None | 29 |
| Mild | 37 |
| Moderate | 33 |
| Severe | 0 |
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.
| participants | Combination Therapy |
|---|---|
| None | 53 |
| Mild | 27 |
| Moderate | 16 |
| Severe | 3 |
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.
| participants | Combination Therapy |
|---|---|
| None | 49 |
| Mild | 27 |
| Moderate | 20 |
| Severe | 3 |
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.
| participants | Combination Therapy |
|---|---|
| None | 67 |
| Mild | 18 |
| Moderate | 9 |
| Severe | 5 |
Collected over 12 Weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Combination Therapy | — | 0/99 (0%) | 32/99 (32.3%) |
| Event | Combination Therapy |
|---|---|
| Application Site BurnGeneral disorders | 32/99 |
| Application Site DrynessGeneral disorders | 24/99 |
| Application Site ErythemaGeneral disorders | 10/99 |
| Application Site ExfoliationGeneral disorders | 7/99 |
| Application Site DiscomfortGeneral disorders | 6/99 |
| Age, Continuous(years) | Combination Therapy |
|---|---|
| Mean | 18.2 ± 5.40 |
| Sex: Female, Male(Participants) | Combination Therapy |
|---|---|
| Female | 56 |
| Male | 44 |
| Race (NIH/OMB)(Participants) | Combination Therapy |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 2 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 10 |
| White | 77 |
| More than one race | 10 |
| Unknown or Not Reported | 0 |
| Ethnicity (NIH/OMB)(Participants) | Combination Therapy |
|---|---|
| Hispanic or Latino | 7 |
| Not Hispanic or Latino | 93 |
| Unknown or Not Reported | 0 |
| Duration of Acne(years) | Combination Therapy |
|---|---|
| Mean | 4.0 ± 3.91 |
| Fitzpatrick Skin Type(participants) | Combination Therapy |
|---|---|
| I | 1 |
| II | 27 |
| III | 38 |
| IV | 22 |
| V | 4 |
| VI | 8 |
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Galderma R&D