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Acne VulgarisPhase 3NCT01445301

Study STF115287, a Clinical Confirmation Study of GSK2585823 in the Treatment of Acne Vulgaris in Japanese Subjects

A Phase 3 study testing GSK2585823(CLDM 1%-BPO 3% gel) and CLDM 1% gel twice daily in people with Acne Vulgaris, run by GlaxoSmithKline at 26 sites in Japan.

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

This is a multicenter, randomized, single-blinded (investigator's blinded), active-controlled (clindamycin [CLDM] 1% gel), parallel-group study in Japanese subjects with acne vulgaris to demonstrate the efficacy of GSK2585823 (CLDM 1%-benzoyl peroxide [BPO] 3% gel) when applied once or twice daily for 12 weeks. 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?
GSK2585823(CLDM 1%-BPO 3% gel) and CLDM 1% gel twice daily
Could I receive a placebo?
No, everyone receives an active treatment
How many people
800 participants
Where
26 sitesJapan
Study dates
27 Sep 2011to 2 Aug 2012
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 or female subjects 12 to 45 years (inclusive) of age in good general health.
  • Subjects must have both on the face:
  • A minimum of 17 but not more than 60 inflammatory lesions (papules/pustules), including nasal lesions.
  • And B) A minimum of 20 but not more than 150 non-inflammatory lesions (open/closed comedones), including nasal lesions.
  • An ISGA score of 2 or greater at baseline.
  • Females of childbearing potential and women who are less than 2 years from their last menses must agree to use the contraception.
  • The ability and willingness to follow all study procedures and attend all scheduled visits.
  • The ability to understand and sign a written informed consent form (Written informed consent must be obtained also from the parent or guardian in case of subject under 20 years of age at the time of given consent).

Who cannot join

  • Have any nodule-cystic lesions at baseline.
  • Are pregnant or breast-feeding.
  • Have a history or presence of regional enteritis, inflammatory bowel disease (e.g., ulcerative colitis, pseudomembranous colitis, chronic diarrhea or antibiotic-associated colitis) or similar symptoms.
  • Used any of the following agents on the face within the previous 2 weeks:Topical antibiotics (or systemic antibiotics);Topical anti-acne medications (e.g., BPO, azelaic acid, resorcinol, salicylates);Abradants, facials, or peels containing glycolic or other acids;Masks, washes or soaps containing BPO, sulfacetamide sodium, or salicylic acid;Non-mild facial cleansers (e.g., facial scrub, cleansers containing agents with anti-inflammatory action); Moisturizers that contain retinol, salicylic acid, or α- or β-hydroxy acids;Astringents and toner (Subjects are allowed to enroll in this study, if the subject has been on treatment for more than 2 consecutive weeks prior to start of investigational product use).
  • Used the following agents on the face or performed the following procedure within the previous 4 weeks:Topical corticosteroids (Use of inhaled, intra-articular, or intra-lesional steroids other than for facial acne is acceptable);Facial procedure (such as chemical or laser peel, microdermabrasion, blue light treatment, etc.).
  • Used systemic retinoids within the previous 6 months or topical retinoids on the face within the previous 6 weeks.
Show all 17Show fewer
  • Received treatment with estrogens, androgens, or anti-androgenic agents within the previous 12 weeks (Subjects who have been treated with the above agents for more than 12 consecutive weeks prior to start of investigational product are allowed to enrol as long as they do not expect to change dose, drug, or discontinue use during the study).
  • Used any medication that in the opinion of the investigator may affect this clinical study or evaluation of the study.
  • Plan to use medications that are reported to exacerbate acne (e.g., mega-doses of certain vitamins, such as vitamin D [>2000 IU/day] and vitamin B12 [>1 mg/day], corticosteroids*, androgens, haloperidol, halogens [e.g., iodide and bromide], lithium, hydantoin, and phenobarbital).
  • : except the using of topical corticosteroids (e.g., inhaled, intra-articular, or intra-lesional steroids) other than for facial acne.
  • Have a known hypersensitivity or have had previous allergic reaction to any of the components of the investigational product.
  • Used any investigational therapy within the previous 12 weeks, or plan to participate in another clinical study at the same time.
  • Participated in Japanese clinical studies planned by GlaxoSmithKline K.K. in the development of investigational products for acne vulgaris.
  • Are currently abusing drugs or alcohol.
  • Have a significant medical history of being immunocompromised.
  • People as follows and the family members:Employees of GlaxoSmithKline, contract research organization (CRO) or site management organization (SMO);Investigators.
  • Have other conditions that would put the subject at unacceptable risk for participation in the study.

Trial locations and contacts

26 sites in 1 country.

26 sites in 1 country

Japan26 sites

  • GSK Investigational Site

    Chiba, 273-0046

  • GSK Investigational Site

    Hokkaido, 002-8022

  • GSK Investigational Site

    Hokkaido, 003-0833

  • GSK Investigational Site

    Hokkaido, 004-0074

  • GSK Investigational Site

    Hokkaido, 004-0876

  • GSK Investigational Site

    Hokkaido, 006-0022

  • GSK Investigational Site

    Hokkaido, 060-0063

  • GSK Investigational Site

    Hokkaido, 062-0042

  • GSK Investigational Site

    Hokkaido, 064-0915

  • GSK Investigational Site

    Hokkaido, 066-0021

  • GSK Investigational Site

    Hokkaido, 066-0064

  • GSK Investigational Site

    Hokkaido, 069-0813

  • GSK Investigational Site

    Hokkaido, 090-0832

  • GSK Investigational Site

    Hokkaido, 093-0016

  • GSK Investigational Site

    Kanagawa, 211-0063

  • GSK Investigational Site

    Kanagawa, 221-0825

  • GSK Investigational Site

    Osaka, 532-0026

  • GSK Investigational Site

    Osaka, 559-0017

  • GSK Investigational Site

    Osaka, 572-0838

  • GSK Investigational Site

    Osaka, 593-8324

  • GSK Investigational Site

    Saitama, 350-1305

  • GSK Investigational Site

    Tokyo, 111-0053

  • GSK Investigational Site

    Tokyo, 141-0031

  • GSK Investigational Site

    Tokyo, 150-0021

  • GSK Investigational Site

    Tokyo, 169-0075

  • GSK Investigational Site

    Tokyo, 194-0013

Other trials in Japan

About this study

Official title: Study STF115287, a Clinical Confirmation Study of GSK2585823 (Clindamycin 1%-Benzoyl Peroxide 3% Gel) in the Treatment of Acne Vulgaris in Japanese Subjects. - A Multicenter, Randomized, Single-blind, Active-controlled, Parallel-group Study -

This is a multicenter, randomized, single-blinded (investigator's blinded), active-controlled (clindamycin [CLDM] 1% gel), parallel-group study in Japanese subjects with acne vulgaris to demonstrate the efficacy of GSK2585823 (CLDM 1%-benzoyl peroxide [BPO] 3% gel) when applied once or twice daily for 12 weeks. This study will also evaluate the safety of GSK2585823 when applied topically either once or twice daily for 12 weeks.

Read the detailed description

Main inclusion criteria will be 12 to 45 years of age, who have an Investigator Static Global Assessment (ISGA) score of 2 or greater at baseline visit, and have both 17 to 60 facial inflammatory lesions (papules plus pustules) and 20 to 150 facial non-inflammatory lesions (open and closed comedones), including nasal lesions. The primary objectives are to demonstrate the superiority of GSK2585823 twice daily to CLDM twice daily in total lesion counts, and to demonstrate the non-inferiority of GSK2585823 once daily to CLDM twice daily in total lesion counts. The secondary objectives are to demonstrate the non-inferiority of GSK2585823 once daily to CLDM twice daily in inflammatory lesion counts, and to evaluate the efficacy of GSK2585823 once or twice daily compared with CLDM twice daily at each visit. A total of 800 subjects will be enrolled and randomly assigned to one of the groups.

Conditions
Acne Vulgaris
Being tested
GSK2585823(CLDM 1%-BPO 3% gel), CLDM 1% gel twice daily
Keywords
twice daily, once daily, CLDM 1%-BPO 3% gel, Clindamycin (CLDM), benzoyl peroxide (BPO), inflammatory lesion, non-inflammatory lesion, 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.

  • GSK2585823(CLDM 1%-BPO 3% gel)Drug

    Also called GSK2585823

    Topical gel in 1 g containing clindamycin 10 mg and benzoyl peroxide 30 mg

  • CLDM 1% gel twice dailyDrug

    Also called CLDM

    Topical gel containing clindamycin 10 mg/1 g gel

Study groups in NCT01445301
Study groupRoleWhat they receive
GSK2585823(CLDM 1%-BPO 3% gel) once dailyExperimentalSubjects will apply in a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin). Also, the dose regimen will be once daily in the evening/bedtime.
Receives: Drug: GSK2585823(CLDM 1%-BPO 3% gel)
GSK2585823(CLDM 1%-BPO 3% gel) twice dailyExperimentalSubjects will apply in a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin). Also, the dose regimen will be twice daily in the morning and evening/bedtime.
Receives: Drug: GSK2585823(CLDM 1%-BPO 3% gel)
CLDM 1% gel twice dailyActive comparatorSubjects will apply in a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin). Also, the dose regimen will be twice daily in the morning and evening/bedtime.
Receives: Drug: CLDM 1% gel twice daily

What is being measured

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

  1. Absolute Change From Baseline to Week 12 in Total Lesion Counts.

    The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedones) on the face at each study visit. An open comedone was an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedone was a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule was a small, raised, red, dome-shaped palpable lesion. A pustule was a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule might be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter. Day 1 was Baseline and change from baseline was calculated by subtracting the Baseline value from post-randomization value at Week 12.

    Measured: Baseline (Day 1) and Week 12

Secondary outcomes (9)

  1. Absolute Change From Baseline to Weeks 1, 2, 4, and 8 in Total Lesion Counts

    The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedones) on the face at each study visit. An open comedone was an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedone was a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule was a small, raised, red, dome-shaped palpable lesion. A pustule was a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule might be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter. Day 1 was Baseline and change from baseline was calculated by subtracting the Baseline value from value at indicated time points.

    Measured: Baseline (Day 1) and Weeks 1, 2, 4, and 8

  2. Absolute Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory and Non-inflammatory Lesion Counts

    The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedones) on the face at each study visit. An open comedone was an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedone was a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule was a small, raised, red, dome-shaped palpable lesion. A pustule was a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule might be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter. Day 1 was Baseline and change from baseline was calculated by subtracting the Baseline value from value at indicated time points.

    Measured: Baseline (Day 1) and Weeks 1, 2, 4, 8, and 12

  3. Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts

    The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedones) on the face at each study visit. An open comedone was an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedone was a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule was a small, raised, red, dome-shaped palpable lesion. A pustule was a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule might be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter. Day 1 was Baseline and change from baseline was calculated by subtracting the Baseline value from value at indicated time points.( Weeks 1, 2, 4, 8 and 12)

    Measured: Baseline (Day 1) and Weeks 1, 2, 4, 8, and 12

  4. Percentage of Participants With a Minimum 2-grade Improvement From Baseline to Week 12 in Investigator's Static Global Assessment (ISGA) Score

    Proportion of participants with at least a 2-Grade Improvement in ISGA was reported using a 5 point scale which indicates Score 0 (Clear): skin with no inflammatory or non-inflammatory lesions, Score 1 (Almost Clear): rare non-inflammatory lesions with no more than rare papules, Score 2 (Mild): greater than Grade 1, some non-inflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions), Score 3 (Moderate): greater than Grade 2, many non-inflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion, Score 4 (Severe): greater than Grade 3, many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions and 5(very severe): many non-inflammatory and inflammatory lesions and more than a few nodular lesions. May have cystic lesions. The investigator assessed ISGA score at baseline (Week 0/Day 1) and Weeks 1, 2, 4, 8, and 12. The area evaluated ISGA was limited to the face.

    Measured: Baseline (Day 1) and Week 12

  5. Percentage of Participants With an ISGA Score of 0 (Clear) or 1 (Almost Clear) at Weeks 1, 2, 4, 8, and 12

    Proportion of participants with at least a 2-Grade Improvement in ISGA was reported using a 5 point scale which indicates Score 0 (Clear): skin with no inflammatory or non-inflammatory lesions, Score 1 (Almost Clear): rare non-inflammatory lesions with no more than rare papules, Score 2 (Mild): greater than Grade 1, some non-inflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions), Score 3 (Moderate): greater than Grade 2, many non-inflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion, Score 4 (Severe): greater than Grade 3, many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions and 5 (very severe): many non-inflammatory and inflammatory lesions and more than a few nodular lesions. May have cystic lesions. The investigator assessed ISGA score at baseline (Week 0/Day 1) and Weeks 1, 2, 4, 8, and 12. The area evaluated ISGA was limited to the face.

    Measured: Week 1, 2, 4, 8, and 12

  6. Percentage of Participants Who Have a Reduction of at Least 50 Percent in Total Lesions

    The percentage of participants who had reduction in total lesions (inflammatory and non-inflammatory) of at least 50 percent from Baseline at Weeks 1, 2, 4, 8, and 12 was measured.

    Measured: Baseline (Day 1) and Week 1, 2, 4, 8, and 12

  7. Minimum Inhibitory Concentration (MIC) of Clinical Isolates to Antibiotics CLDM and Nadifloxacin (NDFX)

    MIC50 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 50% of isolates from a particular organism). MIC90 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 90% of isolates from a particular organism) for the susceptibility of clinical isolates (Propionibacterium acnes before and after application of the CLDM and NDFX was reported. MIC50 and MIC90 values are single measurements for the entire population and not measured on a per-participant basis.

    Measured: Baseline (Day 1) and Week12

  8. Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12

    Erythema (redness), dryness, and peeling, were evaluated independently by the investigator on a five point scale from 0 to 4 defined as 0-none, 1-very minimal, 2-mild, 3-moderate, 4-severe. Day 1 was Baseline and Change from Baseline was calculated by subtracting Baseline value from value at specified time points (Week 1, 2, 4, 8, and 12).

    Measured: Baseline (Day 1) and Week 1, 2, 4, 8, and 12

  9. Change in Participant Assessment of Tolerability ( Itching and Burning/Stinging ) From Baseline to Weeks 1, 2, 4, 8 and 12

    Burning/stinging, itching were evaluated independently by the participant on a five point scale from 0 to 4 defined as 0-none, 1-very minimal, 2-mild, 3-moderate, 4-severe. Day 1 was Baseline and Change from Baseline was calculated by subtracting Baseline value from value at specified time points (Week 1, 2, 4, 8, and 12).

    Measured: Baseline (Day 1) and Week 1, 2, 4, 8 and 12

Timeline

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

  1. First posted3 Oct 2011 (estimated)
  2. Study start27 Sep 2011
  3. Primary completion2 Aug 2012
  4. Study completion2 Aug 2012

Resources

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
Investigator
Enrolment
800 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01445301
Sponsor's protocol ID
115287
Status last verified
Sep 2017
First submitted
15 Sep 2011
Last updated
27 Apr 2018
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GSK2585823(CLDM 1%-BPO 3% gel) and CLDM 1% gel twice daily in people with Acne Vulgaris, run by GlaxoSmithKline at 26 sites in Japan.

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 8 inclusion and 17 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 27 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in Japan. 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 27 Apr 2018). 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 From Baseline to Week 12 in Total Lesion Counts. (time frame: Baseline (Day 1) and Week 12). 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 NCT01445301.

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 27 Apr 2018.

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