Two-week Study to Compare the Tolerance and Irritation Potential of Two Combination Topical Gel Acne Medications
This study has been completed.
Sponsor:
Stiefel, a GSK Company
Collaborator:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00926367
First received: June 21, 2009
Last updated: July 11, 2011
Last verified: July 2011
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Results First Received: September 7, 2010
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Safety Study; Intervention Model: Parallel Assignment; Masking: Single Blind (Outcomes Assessor); Primary Purpose: Treatment |
| Condition: |
Acne Vulgaris |
| Interventions: |
Drug: Clindamycin and benzoyl peroxide Drug: benzoyl peroxide 2.5% and adapalene 0.1% gel |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| Clinical research center. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| Panelists who met the eligibility criteria and were willing to participate in the study were required to undergo a 3-day pre-trial conditioning period where they had to stop the use of all facial products. Panelists were required to use the provided Soap Free Cleanser (SFC) for washing their face and were allowed to apply their normal makeup. |
Reporting Groups
| Description | |
|---|---|
| Duac | Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide |
| Epiduo | Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene |
Participant Flow: Overall Study
| Duac | Epiduo | |
|---|---|---|
| STARTED | 25 | 27 |
| COMPLETED | 23 | 24 |
| NOT COMPLETED | 2 | 3 |
| Withdrawal by Subject | 0 | 1 |
| Lost to Follow-up | 1 | 0 |
| Skin Irritation | 1 | 2 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| Duac | Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide |
| Epiduo | Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene |
| Total | Total of all reporting groups |
Baseline Measures
| Duac | Epiduo | Total | |
|---|---|---|---|
|
Number of Participants
[units: participants] |
25 | 27 | 52 |
|
Age
[units: participants] |
|||
| <=18 years | 1 | 1 | 2 |
| Between 18 and 65 years | 24 | 26 | 50 |
| >=65 years | 0 | 0 | 0 |
|
Gender
[units: participants] |
|||
| Female | 23 | 26 | 49 |
| Male | 2 | 1 | 3 |
|
Region of Enrollment
[units: participants] |
|||
| United States | 25 | 27 | 52 |
Outcome Measures
| 1. Primary: | Skin Erythema (Redness) [ Time Frame: Baseline, Day 1 through Day 14 ] |
| 2. Primary: | Skin Dryness [ Time Frame: Baseline, Day 1 through Day 14 ] |
| 3. Secondary: | Skin Moisture and Hydration [ Time Frame: Baseline, Days 3, 7, and 14 ] |
| 4. Secondary: | Skin Hydration [ Time Frame: Baseline, 4 hrs. post 1st Treatment, Days 3, 7, and 14 ] |
| 5. Secondary: | Self Assessment of Burning [ Time Frame: Baseline, Day 1 through Day 14 ] |
| 6. Secondary: | Self Assessment of Stinging [ Time Frame: Baseline, Day 1 through Day 14 ] |
| 7. Secondary: | Self Assessment of Dryness [ Time Frame: Baseline, Day 1 through Day 14 ] |
| 8. Secondary: | Self Assessment of Texture (Roughness) [ Time Frame: Baseline, Day 1 through Day 14 ] |
| 9. Secondary: | Self Assessment of Pain [ Time Frame: Baseline, Day 1 through Day 14 ] |
| 10. Secondary: | Self Assessment of Crusting [ Time Frame: Baseline, Day 1 through Day 14 ] |
| 11. Secondary: | Self Assessment of Blistering [ Time Frame: Baseline, Day 1 through Day 14 ] |
| 12. Secondary: | Self Assessment of Oiliness [ Time Frame: Baseline, Day 1 through Day 14 ] |
| 13. Secondary: | Product Acceptability and Preference Questionnaire - How do You Rate the Comfort of the Skin Where You Are Currently Treating With the Study Product? [ Time Frame: Day 14 ] |
| 14. Secondary: | Product Acceptability and Preference Questionnaire - How Compliant Were You With Applying the Study Product Each and Every Day? [ Time Frame: Day 14 ] |
| 15. Secondary: | Product Acceptability and Preference Questionnaire - Did You Feel That Your Skin Was Hydrated and Moisturized While You Were on Your Study Product? [ Time Frame: Day 14 ] |
| 16. Secondary: | Product Acceptability and Preference Questionnaire - Was the Study Product Easy to Use With Make-up? [ Time Frame: Day 14 ] |
| 17. Secondary: | Product Acceptability and Preference Questionnaire - What Was Your Overall Satisfaction of the Study Product? [ Time Frame: Day 14 ] |
| 18. Secondary: | Product Acceptability and Preference Questionnaire - How do You Rate the Ease of Application of the Study Product? [ Time Frame: Day 14 ] |
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| Principal Investigators are NOT employed by the organization sponsoring the study. |
| There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. |
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| No text entered. |
Results Point of Contact:
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343
Organization: GlaxoSmithKline
phone: 866-435-7343
No publications provided
| Responsible Party: | Cheri A. Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT00926367 History of Changes |
| Other Study ID Numbers: | C0000-405 |
| Study First Received: | June 21, 2009 |
| Results First Received: | September 7, 2010 |
| Last Updated: | July 11, 2011 |
| Health Authority: | United States: Institutional Review Board |