Acne VulgarisPhase 3NCT00891982

A Clinical Study to Evaluate the Tolerability of a Topical Antibiotic and Retinoid Used in a Combined Regimen With a BPO Wash

A Phase 3 study testing CTGel/ BPO Wash and Soap Free Cleanser and CTGel in people with Acne Vulgaris, run by Stiefel, a GSK Company at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to evaluate the tolerability of a combined regimen of a topical antibiotic and retinoid and a benzoyl peroxide wash. Read more about this study

Who is it for?: Ages 12 to 45 years
Conditions the study is for: Acne Vulgaris
What is being tested?: CTGel/ BPO Wash and Soap Free Cleanser and CTGel
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 5 sitesUnited States
Study dates: 1 Apr 2009to 5 Jun 2009
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 45 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Subjects with mild to moderate facial acne vulgaris, with no history of known or suspected hypersensitivity or previous allergic reaction to any of the ingredients of the study products (eg, topical antibiotics, retinoids or benzoyl peroxide), capable of understanding and willing to provide signed and dated written voluntary informed consent and able to complete the study and to comply with study instructions.
Female subjects of childbearing potential must have a negative urine pregnancy test result at baseline and practice a reliable method of contraception throughout the study.

Who cannot join

Use of topical antibiotics on the face within the past 2 weeks or use of systemic antibiotics within the past 4 weeks.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Dermatology Associates Research
Coral Gables, Florida, 33134
Dermatology Consulting Services
High Point, North Carolina, 27262
The Skin Wellness Center, PC
Knoxville, Tennessee, 37922
Premier Clinical Research
Spokane, Washington, 99204
Grekin Skin Institute
Warren, Michigan, 48088

Other trials in United States

About this study

Official title: A Phase 3B, Multicenter, Assessor-Blinded Study of the Tolerability of Clindamycin 1%-Tretinoin 0.025% Gel Used in Conjunction With Benzoyl Peroxide 4% Wash in Subjects With Mild to Moderate Facial Acne Vulgaris

The purpose of this study is to evaluate the tolerability of a combined regimen of a topical antibiotic and retinoid and a benzoyl peroxide wash.

Conditions: Acne Vulgaris
Being tested: CTGel/ BPO Wash, Soap Free Cleanser and CTGel
Keywords: Acne Vulgaris
Medical subject headings: Acne Vulgaris

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CTGel/ BPO WashDrug
Also called Veltin
Benzoyl Peroxide (BPO) wash will be used once daily in the morning for 28 days
Clindamycin and Tretinoin (CT) gel will be used once daily in the evening for 28 days.
Soap Free Cleanser and CTGelDrug
Also called Veltin
Soap Free Cleanser will be used once daily in the morning for 28 days
Clindamycin and Tretinoin gel will be used once daily in the evening for 28 days.

Study groups in NCT00891982
Study group	Role	What they receive
CTGel plus BPO wash	Experimental	Benzoyl peroxide (BPO) Wash in the morning and CTGel in the evening Receives: Drug: CTGel/ BPO Wash
CTGel	Active comparator	Soap Free Cleanser in the morning and CTGel in the evening Receives: Drug: Soap Free Cleanser and CTGel

What is being measured

The primary outcome is the main question the study is designed to answer.

Local Tolerability - Skin Dryness
Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:
0 - None
1. - Trace
2. - Mild
3. - Moderate
4. - Marked
5. - Severe
Measured: Screening/baseline
Local Tolerability - Skin Dryness
Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:
0 - None
1. - Trace
2. - Mild
3. - Moderate
4. - Marked
5. - Severe
Measured: Week 1
Local Tolerability - Skin Dryness
Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:
0 - None
1. - Trace
2. - Mild
3. - Moderate
4. - Marked
5. - Severe
Measured: Week 2
Local Tolerability - Skin Dryness
Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:
0 - None
1. - Trace
2. - Mild
3. - Moderate
4. - Marked
5. - Severe
Measured: Week 4
Local Tolerability - Skin Scaling
Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:
0 - None
1. - Trace
2. - Mild
3. - Moderate
4. - Marked
5. - Severe
Measured: Screening/baseline
Local Tolerability - Skin Scaling
Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:
0 - None
1. - Trace
2. - Mild
3. - Moderate
4. - Marked
5. - Severe
Measured: Week 1
Local Tolerability - Skin Scaling
Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:
0 - None
1. - Trace
2. - Mild
3. - Moderate
4. - Marked
5. - Severe
Measured: Week 2
Local Tolerability - Skin Scaling
Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:
0 - None
1. - Trace
2. - Mild
3. - Moderate
4. - Marked
5. - Severe
Measured: Week 4
Local Tolerability - Erythema (Redness)
Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:
0 - None
1. - Trace
2. - Mild
3. - Moderate
4. - Marked
5. - Severe
Measured: Screening/baseline
Local Tolerability - Erythema (Redness)
Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:
0 - None
1. - Trace
2. - Mild
3. - Moderate
4. - Marked
5. - Severe
Measured: Week 1
Local Tolerability - Erythema (Redness)
Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:
0 - None
1. - Trace
2. - Mild
3. - Moderate
4. - Marked
5. - Severe
Measured: Week 2
Local Tolerability - Erythema (Redness)
Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:
0 - None
1. - Trace
2. - Mild
3. - Moderate
4. - Marked
5. - Severe
Measured: Week 4

Secondary outcomes (8)

Subject Assessment of Burning/Stinging
Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:
0 - None
1. - Trace
2. - Mild
3. - Moderate
4. - Marked
5. - Severe
Measured: Screening/baseline
Subject Assessment of Burning/Stinging
Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:
0 - None
1. - Trace
2. - Mild
3. - Moderate
4. - Marked
5. - Severe
Measured: Week 1
Subject Assessment of Burning/Stinging
Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:
0 - None
1. - Trace
2. - Mild
3. - Moderate
4. - Marked
5. - Severe
Measured: Week 2
Subject Assessment of Burning/Stinging
Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:
0 - None
1. - Trace
2. - Mild
3. - Moderate
4. - Marked
5. - Severe
Measured: Week 4
Subject Assessment of Itching
Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:
0 - None
1. - Trace
2. - Mild
3. - Moderate
4. - Marked
5. - Severe
Measured: Screening/Baseline
Subject Assessment of Itching
Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:
0 - None
1. - Trace
2. - Mild
3. - Moderate
4. - Marked
5. - Severe
Measured: Week 1
Subject Assessment of Itching
Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:
0 - None
1. - Trace
2. - Mild
3. - Moderate
4. - Marked
5. - Severe
Measured: Week 2
Subject Assessment of Itching
Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:
0 - None
1. - Trace
2. - Mild
3. - Moderate
4. - Marked
5. - Severe
Measured: Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 20095 Jun 2009

First posted1 May 2009 (estimated)
Study start1 Apr 2009
Primary completion1 Jun 2009
Study completion5 Jun 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Acne VulgarisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00891982
Sponsor's protocol ID: 114679
Status last verified: May 2017
First submitted: 29 Apr 2009
Last updated: 24 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Draelos ZD, Potts A, Alio Saenz AB; W0265-306 Study Group. Randomized tolerability analysis of clindamycin phosphate 1.2%-tretinoin 0.025% gel used with benzoyl peroxide wash 4% for acne vulgaris. Cutis. 2010 Dec;86(6):310-8.
PubMed 21284283

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 24 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3B, Multicenter, Assessor-Blinded Study of the Tolerability of Clindamycin 1%-Tretinoin 0.025% Gel Used in Conjunction With Benzoyl Peroxide 4% Wash in Subjects With Mild to Moderate Facial Acne Vulgaris
ClinicalTrials.gov ID: NCT00891982
Acronym / sponsor ID: 114679
Conditions: Acne Vulgaris
Keywords: Acne Vulgaris
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Stiefel, a GSK CompanyIndustry (pharma, biotech, devices)
Collaborators: GlaxoSmithKline
Study start: 1 Apr 2009 (actual)
Primary completion: 1 Jun 2009 (actual)
Study completion: 5 Jun 2009 (actual)
First posted: 1 May 2009 (estimated)
Results: Posted 25 Jul 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate the tolerability of a combined regimen of a topical antibiotic and retinoid and a benzoyl peroxide wash.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
CTGel plus BPO wash	Experimental	Drug: CTGel/ BPO WashBenzoyl peroxide (BPO) Wash in the morning and CTGel in the evening
CTGel	Active comparator	Drug: Soap Free Cleanser and CTGelSoap Free Cleanser in the morning and CTGel in the evening

Who may qualify

Ages: 12 to 45 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (2 listed)

Subjects with mild to moderate facial acne vulgaris, with no history of known or suspected hypersensitivity or previous allergic reaction to any of the ingredients of the study products (eg, topical antibiotics, retinoids or benzoyl peroxide), capable of understanding and willing to provide signed and dated written voluntary informed consent and able to complete the study and to comply with study instructions.
Female subjects of childbearing potential must have a negative urine pregnancy test result at baseline and practice a reliable method of contraception throughout the study.

Key exclusion criteria (1 listed)

Use of topical antibiotics on the face within the past 2 weeks or use of systemic antibiotics within the past 4 weeks.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CTGel/ BPO WashAlso: VeltinBenzoyl Peroxide (BPO) wash will be used once daily in the morning for 28 days Clindamycin and Tretinoin (CT) gel will be used once daily in the evening for 28 days.	Drug	CTGel plus BPO wash
Soap Free Cleanser and CTGelAlso: VeltinSoap Free Cleanser will be used once daily in the morning for 28 days Clindamycin and Tretinoin gel will be used once daily in the evening for 28 days.	Drug	CTGel

Primary outcome

Local Tolerability - Skin Dryness
Time frame: Screening/baseline
Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale: 0 - None 1. - Trace 2. - Mild 3. - Moderate 4. - Marked 5. - Severe
Local Tolerability - Skin Dryness
Time frame: Week 1
Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale: 0 - None 1. - Trace 2. - Mild 3. - Moderate 4. - Marked 5. - Severe
Local Tolerability - Skin Dryness
Time frame: Week 2
Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale: 0 - None 1. - Trace 2. - Mild 3. - Moderate 4. - Marked 5. - Severe
Local Tolerability - Skin Dryness
Time frame: Week 4
Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale: 0 - None 1. - Trace 2. - Mild 3. - Moderate 4. - Marked 5. - Severe
Local Tolerability - Skin Scaling
Time frame: Screening/baseline
Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale: 0 - None 1. - Trace 2. - Mild 3. - Moderate 4. - Marked 5. - Severe
Local Tolerability - Skin Scaling
Time frame: Week 1
Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale: 0 - None 1. - Trace 2. - Mild 3. - Moderate 4. - Marked 5. - Severe
Local Tolerability - Skin Scaling
Time frame: Week 2
Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale: 0 - None 1. - Trace 2. - Mild 3. - Moderate 4. - Marked 5. - Severe
Local Tolerability - Skin Scaling
Time frame: Week 4
Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale: 0 - None 1. - Trace 2. - Mild 3. - Moderate 4. - Marked 5. - Severe
Local Tolerability - Erythema (Redness)
Time frame: Screening/baseline
Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale: 0 - None 1. - Trace 2. - Mild 3. - Moderate 4. - Marked 5. - Severe
Local Tolerability - Erythema (Redness)
Time frame: Week 1
Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale: 0 - None 1. - Trace 2. - Mild 3. - Moderate 4. - Marked 5. - Severe
Local Tolerability - Erythema (Redness)
Time frame: Week 2
Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale: 0 - None 1. - Trace 2. - Mild 3. - Moderate 4. - Marked 5. - Severe
Local Tolerability - Erythema (Redness)
Time frame: Week 4
Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale: 0 - None 1. - Trace 2. - Mild 3. - Moderate 4. - Marked 5. - Severe

8 secondary outcomes

Subject Assessment of Burning/Stinging
Time frame: Screening/baseline
Subject Assessment of Burning/Stinging
Time frame: Week 1
Subject Assessment of Burning/Stinging
Time frame: Week 2
Subject Assessment of Burning/Stinging
Time frame: Week 4
Subject Assessment of Itching
Time frame: Screening/Baseline
Subject Assessment of Itching
Time frame: Week 1
Subject Assessment of Itching
Time frame: Week 2
Subject Assessment of Itching
Time frame: Week 4

Results and safety

Results posted to the registry on 25 Jul 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CTGel Plus BPO Wash	30	28
CTGel	31	30

Primary outcome: Local Tolerability - Skin Dryness

Time frame: Screening/baseline. Number. Unit: participants

Measure	CTGel Plus BPO Wash n = 30	CTGel n = 31
Grade 0	28	26
Grade 1	2	4
Grade 2	0	1
Grade 3	0	0
Grade 4	0	0
Grade 5	0	0
Missing	0	0

Primary outcome: Local Tolerability - Skin Dryness

Time frame: Week 1. Number. Unit: participants

Measure	CTGel Plus BPO Wash n = 30	CTGel n = 31
Grade 0	12	16
Grade 1	5	8
Grade 2	5	5
Grade 3	6	0
Grade 4	0	1
Grade 5	1	0
Missing	1	1

Primary outcome: Local Tolerability - Skin Dryness

Time frame: Week 2. Number. Unit: participants

Measure	CTGel Plus BPO Wash n = 30	CTGel n = 31
Grade 0	15	17
Grade 1	7	8
Grade 2	5	4
Grade 3	1	0
Grade 4	0	0
Grade 5	0	0
Missing	2	2

Primary outcome: Local Tolerability - Skin Dryness

Time frame: Week 4. Number. Unit: participants

Measure	CTGel Plus BPO Wash n = 30	CTGel n = 31
Grade 0	19	19
Grade 1	7	11
Grade 2	2	1
Grade 3	0	0
Grade 4	0	0
Grade 5	0	0
Missing	2	0

8 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CTGel Plus BPO Wash	0 of 30 (0%)	1 of 30 (3.3%)	Not reported
CTGel	0 of 31 (0%)	5 of 31 (16.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 21284283Draelos ZD, Potts A, Alio Saenz AB; W0265-306 Study Group. Randomized tolerability analysis of clindamycin phosphate 1.2%-tretinoin 0.025% gel used with benzoyl peroxide wash 4% for acne vulgaris. Cutis. 2010 Dec;86(6):310-8.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CTGel/ BPO Wash and Soap Free Cleanser and CTGel in people with Acne Vulgaris, run by Stiefel, a GSK Company at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Local Tolerability - Skin Dryness (time frame: Screening/baseline). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00891982, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2017.