Acne VulgarisPhase 3NCT01915732
A Efficacy and Safety of Duac™Compared With Clindamycin Phosphate Gel in the Treatment of Mild to Moderate Acne Vulgaris
A Phase 3 study testing Duac™Once Daily Gel and 1% clindamycin phosphate gel in people with Acne Vulgaris, run by GlaxoSmithKline at 24 sites in China.
Trial summary
This is a multicentre, randomized, assessor-blind, comparator-controlled evaluation of the efficacy, safety, and tolerability of Duac™Once Daily Gel and clindamycin phosphate gel in the topical treatment of mild to moderate facial acne vulgaris. A total of 1020 subjects will be enrolled, 510 per study arm. 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?
- Duac™Once Daily Gel and 1% clindamycin phosphate gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,018 participants
- Where
- 24 sitesChina
- Study dates
- Apr 2013to Apr 2014
- 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
- Male and female subjects between 12 and 45 years of age, inclusive age will be calculated by date of birth, from 0 at birth.
- Subjects who have:
- A minimum of 17 but not more than 60 facial inflammatory lesions (papules plus pustules), and no more than 1 facial nodular lesion, with NO cystic lesions.
- and ii. A minimum of 20 but not more than 125 facial noninflammatory lesions (open and closed comedones).
- Subjects who have an ISGA score of 2 or 3 at Baseline.
- Subjects 18 years of age or older must provide written informed consent (according to any local or national authorization requirements). Subjects under the legal age of consent must provide assent and have written informed consent of both the subject and a parent or the legal guardian (according to any local or national authorization requirements).
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- Subjects who are willing and able to complete the study, to understand and comply with the requirements of the study, abide by the restrictions, apply the medication as instructed, and return for the required study visits.
- Subjects who are in good health and free from any clinically significant disease, other than acne vulgaris, that might interfere with the study evaluations.
- Female subjects of childbearing potential must have a negative pregnancy test at baseline. Sexually active females of childbearing potential participating in the study must use a medically acceptable method of contraception for at least 6 consecutive months prior to start of study treatment, and must use a medically acceptable method of contraception while receiving protocol-assigned product. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant; including perimenopausal women who are less than 2 years from their last menses. Medically acceptable contraceptive methods include the following:
- Hormonal contraception, including oral, injectable, or implantable methods started at least 6 months prior to screening.
- Reliable barrier methods include condoms and diaphragms. A cervical cap is also a reliable barrier method, provided that the female subject has never given birth naturally. The combined use of a condom and spermicide constitute 2 forms of acceptable nonhormonal contraception, provided that they are both used properly. The use of spermicide alone and the improper use of condoms are inferior methods of contraception. Subjects with surgical sterilization, including tubal ligation or partner's vasectomy, must use a form of nonhormonal contraception. A barrier method or sterilization plus spermatocide are acceptable.
- Females who are not currently sexually active must agree to use a medically accepted method of contraception should they become sexually active while participating in the study.
- Subjects who have been treated with estrogens, androgens, or anti-androgenic agents used for prevention of pregnancy (and not for control of acne) for at least 6 consecutive months prior to the first dose of investigational product may enrol as long as they do not expect to change dose, drug, or discontinue use during the study.
Who cannot join
- Female subjects who are pregnant, trying to become pregnant, or who are lactating.
- Subjects who have cystic acne lesions, acne conglobata, acne fulminans, or secondary acne (e.g. chloracne or drug-induced acne).
- Subjects who have any clinically relevant finding at their baseline physical examination or medical history such as severe systemic diseases or diseases of the facial skin other than acne vulgaris.
- Subjects who have facial hair that may prevent the accurate assessment of acne vulgaris grade or lesion count.
- Subjects who have a history or presence of regional enteritis or inflammatory bowel disease (e.g. ulcerative colitis, pseudomembranous colitis, chronic diarrhoea, or a history of antibiotic-associated colitis, bloody diarrhoea) or similar symptoms.
- Subjects who have used a prohibited medication, or undergone a prohibited procedure or treatment within the required washout period.
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- Subjects who have a known hypersensitivity or previous allergic reaction to any of the active components, lincomycin, or excipients of the investigational product.
- Subjects who are employees of a clinical research organization involved in the study, Stiefel, or GSK or who are an immediate family member (partner, offspring, parents, siblings, or sibling's offspring) of an employee, the investigator, or his/her study staff.
- Subjects who have a member of the same household in this study at the same time.
- Subjects who have used traditional remedies known to affect acne vulgaris within the last 4 weeks.
- Subjects who have had any major illness within 30 days before study enrolment.
- Subjects who have any other condition that in the judgement of the investigator would put the subject at unacceptable risk for participation in the study.
- Subjects who have participated in any clinical trials or taken any investigate drugs within 4 weeks before study enrolment.
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
China24 sites
GSK Investigational Site
Beijing, 100020
GSK Investigational Site
Beijing, 100034
GSK Investigational Site
Beijing, 100036
GSK Investigational Site
Beijing, 100730
GSK Investigational Site
Changchun, Jilin, 130041
GSK Investigational Site
Changsha, Hunan, 410011
GSK Investigational Site
Changsha, Hunan, 410013
GSK Investigational Site
Chongqing, 400038
GSK Investigational Site
Guangzhou, Guangdong, 510010
GSK Investigational Site
Guangzhou, Guangdong, 510080
GSK Investigational Site
Guangzhou, Guangdong, 510120
GSK Investigational Site
Hangzhou, Zhejiang, 310003
GSK Investigational Site
Hangzhou, Zhejiang, 310009
GSK Investigational Site
Jinan, Shandong, 250022
GSK Investigational Site
Nanjing, Jiangsu, 210029
GSK Investigational Site
Nanjing, Jiangsu, 210042
GSK Investigational Site
Shanghai, 200025
GSK Investigational Site
Shanghai, 200032
GSK Investigational Site
Shanghai, 200040
GSK Investigational Site
Shanghai, 200092
GSK Investigational Site
Shanghai, 200433
GSK Investigational Site
Wuhan, Hebei, 430071
GSK Investigational Site
Wuhan, 430022
GSK Investigational Site
Xian, Shanxi, 710032
About this study
Official title: A Multicentre, Randomized, Assessor-blind, Comparator-Controlled, Parallel-Group Clinical Trial to Establish the Efficacy and Safety of Duac™(1% Clindamycin as Clindamycin Phosphate and 5% Benzoyl Peroxide) Once Daily Gel Compared With Clindamycin Phosphate Gel (1% Clindamycin as Clindamycin Phosphate) Twice Daily in the Treatment of Mild to Moderate Acne Vulgaris.
This is a multicentre, randomized, assessor-blind, comparator-controlled evaluation of the efficacy, safety, and tolerability of Duac™Once Daily Gel and clindamycin phosphate gel in the topical treatment of mild to moderate facial acne vulgaris. A total of 1020 subjects will be enrolled, 510 per study arm. The subjects will be males and females between 12 and 45 years of age, inclusive, at the time of consent, who have mild to moderate facial acne vulgaris.
Subjects will use Duac™Once Daily Gel (once daily in the evening) or clindamycin phosphate gel twice daily (once in the morning and once in the evening) for 12 weeks. The subjects will be evaluated for change in lesion counts, investigator's static global assessment (ISGA), subject's global assessment (SGA), local tolerability and AEs/SAEs at Weeks0, 1, 2, 4, 8, and 12 (or at early withdrawal). In addition, quality of life measures will be performed at every study visit.
- Conditions
- Acne Vulgaris
- Being tested
- Duac™Once Daily Gel, 1% clindamycin phosphate gel
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duac™Once Daily GelDrug
1% clindamycin as clindamycin phosphate and 5% benzoyl peroxide
1% clindamycin phosphate gelDrug
1% clindamycin as clindamycin phosphate
| Study group | Role | What they receive |
|---|---|---|
| Duac™Once Daily Gel | Experimental | Subjects will use Duac™Once Daily Gel (once daily in the evening)for 12 weeks. The subjects will be evaluated for change in lesion counts, ISGA, SGA , local tolerability, and AEs/SAEs at Weeks0, 1, 2, 4, 8, and 12 (or at early withdrawal). In addition, quality of life measures will be performed at every study visit Receives: Drug: 1% clindamycin phosphate gel |
| 1% clindamycin phosphate gel | Active comparator | Subjects will use 1% clinidamycin phosphate gel (twice daily in the morning and evening)for 12 weeks. The subjects will be evaluated for change in lesion counts, ISGA, SGA , local tolerability, and AEs/SAEs at Weeks0, 1, 2, 4, 8, and 12 (or at early withdrawal). In addition, quality of life measures will be performed at every study visit Receives: Drug: Duac™Once Daily Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute Change in Total Lesion Count From Baseline to Week 12
The assessor performed a count of inflammatory lesions (IL) (papules, pustules, nodules, and cysts), non-inflammatory lesions (NIL) (open and closed comedones) and total lesions (the sum of IL and NIL) at each study visit. Lesion counts were confined to the face. Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline. Parameters were estimated using analysis of covariance (ANCOVA) with treatment, center, treatment-by-centre interaction and Baseline lesion count in the model. Missing values were imputed using the last observation carried forward (LOCF), i.e., the last available observation was used to estimate subsequent missing data.
Measured: Baseline (Week 0) and Week 12
Number of Participants With an Improvement of 2 Grades in the Investigator Static Global Assessment (ISGA) Score From Baseline to Week 12
ISGA success is defined as the improvement of 2 grades or more in the participant's acne severity scale at Week 12. Acne severity of the participants' face was assessed by the assessor using the ISGA scale, ranging from 0 to 4: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than one small IL; 2=mild, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: up to many NILs and ILs, but no more than a few NLs. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data.
Measured: Baseline (Week 0) and Week 12
Number of Participants With an Improvement of 2 Grades in the Investigator Static Global Assessment (ISGA) Score From Baseline to Week 12
ISGA success is defined as the improvement of 2 grades or more in the participant's acne severity scale at Week 12. Acne severity of the participants' face was assessed by the assessor using the ISGA scale, ranging from 0 to 4: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than one small IL; 2=mild, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: up to many NILs and ILs, but no more than a few NLs. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data .
Measured: Baseline (Week 0) and Week 12
Secondary outcomes (3)
Absolute Change in Inflammatory Lesion Counts and Non-inflammatory Lesion Counts From Baseline to Week 12
The assessor performed a count of ILs (papules, pustules, nodules, and cysts), NILs (open and closed comedones at each study visit. Lesion counts were confined to the face. Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline. Analysis of covariance (ANCOVA) model was used with terms for Baseline lesion count, treatment, and center. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data.
Measured: Baseline (Week 0) and Week 12
Percent Change in Inflammatory, Non-inflammatory and Total Lesion Counts From Baseline to Week 12
The assessor performed a count of ILs (papules, pustules, nodules, and cysts), NILs (open and closed comedones) and total lesions (the sum of ILs and NILs)at each study visit. Lesion counts were confined to the face. Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline. Analysis of covariance (ANCOVA) model was used with terms for Baseline lesion count, treatment, and center. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data.
Measured: Baseline (Week 0) and Week 12
Number of Participants Who Had an ISGA Score of 0 or 1 at Week 12
The assessor evaluated the acne severity of the participants' face using the ISGA scale, ranging from 0 to 4: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than one small IL; 2=mild, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: up to many NILs and ILs, but no more than a few NLs. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2013 (estimated)
- Study startApr 2013
- Primary completionApr 2014
- Study completionApr 2014
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.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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
- 1,018 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01915732
- Sponsor's protocol ID
- 114543
- Status last verified
- Jan 2017
- First submitted
- 5 Apr 2013
- Last updated
- 28 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Xu JH, Lu QJ, Huang JH, Hao F, Sun QN, Fang H, Gu J, Dong XQ, Zheng J, Luo D, Li FQ, Wang G, Gu H, Tian HQ, Yang HL, Xi LY, Li M, Zheng M, Wu Y, Tu YT, He YL, Zhao G, Sheng WX, Li J, Hamedani AG. A multicentre, randomized, single-blind comparison of topical clindamycin 1%/benzoyl peroxide 5% once-daily gel versus clindamycin 1% twice-daily gel in the treatment of mild to moderate acne vulgaris in Chinese patients. J Eur Acad Dermatol Venereol. 2016 Jul;30(7):1176-82. doi: 10.1111/jdv.13622. Epub 2016 Apr 13.
PubMed 27075705
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Randomized, Assessor-blind, Comparator-Controlled, Parallel-Group Clinical Trial to Establish the Efficacy and Safety of Duac™(1% Clindamycin as Clindamycin Phosphate and 5% Benzoyl Peroxide) Once Daily Gel Compared With Clindamycin Phosphate Gel (1% Clindamycin as Clindamycin Phosphate) Twice Daily in the Treatment of Mild to Moderate Acne Vulgaris.
- ClinicalTrials.gov ID
- NCT01915732
- Acronym / sponsor ID
- 114543
- Conditions
- Acne Vulgaris
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,018 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 5 Aug 2013 (estimated)
- Results
- Posted 25 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicentre, randomized, assessor-blind, comparator-controlled evaluation of the efficacy, safety, and tolerability of Duac™Once Daily Gel and clindamycin phosphate gel in the topical treatment of mild to moderate facial acne vulgaris. A total of 1020 subjects will be enrolled, 510 per study arm. The subjects will be males and females between 12 and 45 years of age, inclusive, at the time of consent, who have mild to moderate facial acne vulgaris.
Subjects will use Duac™Once Daily Gel (once daily in the evening) or clindamycin phosphate gel twice daily (once in the morning and once in the evening) for 12 weeks. The subjects will be evaluated for change in lesion counts, investigator's static global assessment (ISGA), subject's global assessment (SGA), local tolerability and AEs/SAEs at Weeks0, 1, 2, 4, 8, and 12 (or at early withdrawal). In addition, quality of life measures will be performed at every study visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Duac™Once Daily Gel | Experimental | Drug: 1% clindamycin phosphate gelSubjects will use Duac™Once Daily Gel (once daily in the evening)for 12 weeks. The subjects will be evaluated for change in lesion counts, ISGA, SGA , local tolerability, and AEs/SAEs at Weeks0, 1, 2, 4, 8, and 12 (or at early withdrawal). In addition, quality of life measures will be performed at every study visit |
| 1% clindamycin phosphate gel | Active comparator | Drug: Duac™Once Daily GelSubjects will use 1% clinidamycin phosphate gel (twice daily in the morning and evening)for 12 weeks. The subjects will be evaluated for change in lesion counts, ISGA, SGA , local tolerability, and AEs/SAEs at Weeks0, 1, 2, 4, 8, and 12 (or at early withdrawal). In addition, quality of life measures will be performed at every study visit |
Who may qualify
- Ages
- 12 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (13 listed)
- Male and female subjects between 12 and 45 years of age, inclusive age will be calculated by date of birth, from 0 at birth.
- Subjects who have:
- and ii. A minimum of 20 but not more than 125 facial noninflammatory lesions (open and closed comedones).
- Subjects who have an ISGA score of 2 or 3 at Baseline.
- Subjects 18 years of age or older must provide written informed consent (according to any local or national authorization requirements). Subjects under the legal age of consent must provide assent and have written informed consent of both the subject and a parent or the legal guardian (according to any local or national authorization requirements).
Key exclusion criteria (13 listed)
- Female subjects who are pregnant, trying to become pregnant, or who are lactating.
- Subjects who have cystic acne lesions, acne conglobata, acne fulminans, or secondary acne (e.g. chloracne or drug-induced acne).
- Subjects who have any clinically relevant finding at their baseline physical examination or medical history such as severe systemic diseases or diseases of the facial skin other than acne vulgaris.
- Subjects who have facial hair that may prevent the accurate assessment of acne vulgaris grade or lesion count.
- Subjects who have a history or presence of regional enteritis or inflammatory bowel disease (e.g. ulcerative colitis, pseudomembranous colitis, chronic diarrhoea, or a history of antibiotic-associated colitis, bloody diarrhoea) or similar symptoms.
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 |
|---|---|---|
| Duac™Once Daily Gel1% clindamycin as clindamycin phosphate and 5% benzoyl peroxide | Drug | 1% clindamycin phosphate gel |
| 1% clindamycin phosphate gel1% clindamycin as clindamycin phosphate | Drug | Duac™Once Daily Gel |
Primary outcome
Absolute Change in Total Lesion Count From Baseline to Week 12
Time frame: Baseline (Week 0) and Week 12
The assessor performed a count of inflammatory lesions (IL) (papules, pustules, nodules, and cysts), non-inflammatory lesions (NIL) (open and closed comedones) and total lesions (the sum of IL and NIL) at each study visit. Lesion counts were confined to the face. Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline. Parameters were estimated using analysis of covariance (ANCOVA) with treatment, center, treatment-by-centre interaction and Baseline lesion count in the model. Missing values were imputed using the last observation carried forward (LOCF), i.e., the last available observation was used to estimate subsequent missing data.
Number of Participants With an Improvement of 2 Grades in the Investigator Static Global Assessment (ISGA) Score From Baseline to Week 12
Time frame: Baseline (Week 0) and Week 12
ISGA success is defined as the improvement of 2 grades or more in the participant's acne severity scale at Week 12. Acne severity of the participants' face was assessed by the assessor using the ISGA scale, ranging from 0 to 4: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than one small IL; 2=mild, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: up to many NILs and ILs, but no more than a few NLs. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data.
Number of Participants With an Improvement of 2 Grades in the Investigator Static Global Assessment (ISGA) Score From Baseline to Week 12
Time frame: Baseline (Week 0) and Week 12
ISGA success is defined as the improvement of 2 grades or more in the participant's acne severity scale at Week 12. Acne severity of the participants' face was assessed by the assessor using the ISGA scale, ranging from 0 to 4: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than one small IL; 2=mild, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: up to many NILs and ILs, but no more than a few NLs. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data .
3 secondary outcomes
Absolute Change in Inflammatory Lesion Counts and Non-inflammatory Lesion Counts From Baseline to Week 12
Time frame: Baseline (Week 0) and Week 12
Percent Change in Inflammatory, Non-inflammatory and Total Lesion Counts From Baseline to Week 12
Time frame: Baseline (Week 0) and Week 12
Number of Participants Who Had an ISGA Score of 0 or 1 at Week 12
Time frame: Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27075705Xu JH, Lu QJ, Huang JH, Hao F, Sun QN, Fang H, Gu J, Dong XQ, Zheng J, Luo D, Li FQ, Wang G, Gu H, Tian HQ, Yang HL, Xi LY, Li M, Zheng M, Wu Y, Tu YT, He YL, Zhao G, Sheng WX, Li J, Hamedani AG. A multicentre, randomized, single-blind comparison of topical clindamycin 1%/benzoyl peroxide 5% once-daily gel versus clindamycin 1% twice-daily gel in the treatment of mild to moderate acne vulgaris in Chinese patients. J Eur Acad Dermatol Venereol. 2016 Jul;30(7):1176-82. doi: 10.1111/jdv.13622. Epub 2016 Apr 13.
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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
24 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 Duac™Once Daily Gel and 1% clindamycin phosphate gel in people with Acne Vulgaris, run by GlaxoSmithKline at 24 sites in China.
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 13 inclusion and 13 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 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in China. 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 Nov 2014). 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?
Absolute Change in Total Lesion Count From Baseline to Week 12 (time frame: Baseline (Week 0) and Week 12). The study lists 3 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 NCT01915732, 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 28 Feb 2017.