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Acne VulgarisPhase 3NCT01400932

Study STF115288, a Clinical Confirmation Study of GI148512 in the Treatment of Acne Vulgaris in Japanese Subjects

A Phase 3 study testing GI148512 in people with Acne Vulgaris, run by GlaxoSmithKline at 19 sites in Japan.

Completed

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

Official record
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Trial summary

This is a multicenter, randomized, double-blinded, vehicle-controlled, parallel-group study in Japanese subjects with acne vulgaris to demonstrate the efficacy of GI148512 (benzoyl peroxide [BPO] 3% gel) when applied once 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?
GI148512
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
360 participants
Where
19 sitesJapan
Study dates
Jul 2011to Apr 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 (global assessment of severity by the investigator: refer to Section 6.2.1 "Assessment") 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.
  • 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.
  • 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).
Show all 16Show fewer
  • 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 intralesional 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

19 sites in 1 country.

19 sites in 1 country

Japan19 sites

  • GSK Investigational Site

    Kanagawa, 215-0036

  • GSK Investigational Site

    Kanagawa, 220-0004

  • GSK Investigational Site

    Kanagawa, 224-0001

  • GSK Investigational Site

    Kanagawa, 234-0051

  • GSK Investigational Site

    Kanagawa, 240-0013

  • GSK Investigational Site

    Kanagawa, 242-0007

  • GSK Investigational Site

    Osaka, 530-6012

  • GSK Investigational Site

    Osaka, 554-0021

  • GSK Investigational Site

    Saitama, 332-0031

  • GSK Investigational Site

    Tokyo, 102-0072

  • GSK Investigational Site

    Tokyo, 107-0062

  • GSK Investigational Site

    Tokyo, 116-0003

  • GSK Investigational Site

    Tokyo, 150-0047

  • GSK Investigational Site

    Tokyo, 157-0071

  • GSK Investigational Site

    Tokyo, 169-0075

  • GSK Investigational Site

    Tokyo, 180-0004

  • GSK Investigational Site

    Tokyo, 180-0023

  • GSK Investigational Site

    Tokyo, 190-0023

  • GSK Investigational Site

    Tokyo, 195-0053

Other trials in Japan

About this study

Official title: Study STF115288, a Clinical Confirmation Study of GI148512 (Benzoyl Peroxide 3% Gel) in the Treatment of Acne Vulgaris in Japanese Subjects.- A Multicenter, Randomized, Double-blinded, Vehicle-controlled, Parallel-group Study -

This is a multicenter, randomized, double-blinded, vehicle-controlled, parallel-group study in Japanese subjects with acne vulgaris to demonstrate the efficacy of GI148512 (benzoyl peroxide [BPO] 3% gel) when applied once daily for 12 weeks. This study will also evaluate the safety of GI148512 when applied topically once 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 objective is to demonstrate the superiority of GI148512 to vehicle gel in total lesion counts. The secondary objectives are to demonstrate the superiority of GI148512 to vehicle gel in inflammatory lesion counts, and to evaluate the efficacy of GI148512 compared with vehicle gel at each visit. A total of 360 subjects will be enrolled and randomly assigned to one of the groups.

Conditions
Acne Vulgaris
Being tested
GI148512, vehicle gel
Keywords
inflammatory lesion, Benzoyl peroxide (BPO), once daily, acne vulgaris, vehicle gel, clindamycin (CLDM) 1%-BPO 3% gel, non-inflammatory lesion
Medical subject headings
Acne Vulgaris

What participants receive

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

  • GI148512Drug

    Also called Benzoyl Peroxide 3% Gel

    GI148512, Topical gel in 1 g containing benzoyl peroxide 30 mg

  • vehicle gelDrug

    Matching vehicle gel of GI148512, not containing active ingredient (benzoyl peroxide)

Study groups in NCT01400932
Study groupRoleWhat they receive
GI148512 (Benzoyl Peroxide 3% Gel)ExperimentalSubjects 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. Comparison of 2 arms (GI148512 vs vehicle)
Receives: Drug: GI148512
vehicle gelPlacebo 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 once daily in the evening/bedtime.
Receives: Drug: vehicle gel

What is being measured

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

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

    The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedos; diagnosis based on palpation) on the face at each study visit. An open comedo is 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 comedo is a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule is a small, raised, red, dome-shaped palpable lesion. A pustule is a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule may be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter.

    Measured: Baseline and Week 12

Secondary outcomes (8)

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

    The investigator/subinvestigator counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedo) on the face at each study visit. An open comedo is 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 comedo is a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule is a small, raised, red, dome-shaped palpable lesion. A pustule is a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule may be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter.Data were analyzed using an ANCOVA model with terms for Baseline value, treatment, and center.

    Measured: Baseline; Weeks 1, 2, 4, and 8

  2. Absolute Change From Baseline in Inflammatory Lesion (IL) Count and Non-inflammatory Lesion (NIL) Count to Weeks 1, 2, 4, 8, and 12

    The investigator/subinvestigator counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedo) on the face at each study visit. An open comedo is 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 comedo is a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule is a small, raised, red, dome-shaped palpable lesion. A pustule is a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule may be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter. Data were analyzed using an ANCOVA model with terms for Baseline value, treatment, and center.

    Measured: Baseline; Weeks 1, 2, 4, 8, and 12

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

    The percent change from Baseline to Weeks 1, 2, 4, 8, and 12 in lesion counts (total [inflammatory and non-inflammatory], inflammatory [IL], and non-inflammatory [NIL]) was analyzed using an ANOVA model with terms for treatment and center. Percent change from Baseline was calculated as: (post-Baseline value minus Baseline value) * 100.

    Measured: Baseline; Weeks 1, 2, 4 and 8 and 12

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

    Investigators evaluated the acne severity of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no inflammatory lesions (ILs) or non-inflammatory lesions (NILs); 1=almost clear: rare NILs with no more than rare papules; 2=mild acne: greater than Grade 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate acne: greater than Grade 2, up to many NILs and had some ILs, but no more than one small NL; 4=severe acne: greater than Grade 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe acne: many NILs and ILs and more than a few NLs, had cystic lesions.

    Measured: Baseline and Week 12

  5. Number of Participants Who Had an ISGA Score of 0 or 1 at Weeks 1, 2, 4, 8, and 12

    Investigators evaluated the acne severity of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no inflammatory lesions (ILs) or non-inflammatory lesions (NILs); 1=almost clear: rare NILs with no more than rare papules; 2=mild acne: greater than Grade 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate acne: greater than Grade 2, up to many NILs and had some ILs, but no more than one small NL; 4=severe acne: greater than Grade 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe acne: many NILs and ILs and more than a few NLs, had cystic lesions.

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

  6. Number of Participants Who Had a Reduction in Total Lesions of at Least 50% From Baseline to Weeks 1, 2, 4, 8, and 12

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

    Measured: Baseline; Weeks 1, 2, 4, 8, and 12

  7. Mean Change From Baseline in Erythema, Dryness, and Peeling Scores at Weeks 1, 2, 4, 8, 12/Withdrawal

    Erythema (redness), dryness, and peeling were evaluated independently by the investigator as: 0 (absent)=no erythema, dryness, or peeling; 1 (slight)=faint red/pink coloration, barely perceptible dryness with no flakes or fissure, mild localized peeling; 2 (mild)=light red/pink coloration, perceptible dryness with no flakes/fissure, mild and diffuse peeling; 3 (moderate)=medium red coloration, easily noted dryness and flakes but no fissure, moderate and diffuse peeling; 4 (severe)=beet red coloration, dryness with flakes and fissure, prominent dense peeling. Change from Baseline was calculated as the post-Baseline/Withdrawal value minus the Baseline value.

    Measured: Baseline; Weeks 1, 2, 4, 8, 12 or Withdrawal

  8. Mean Change From Baseline in Itching and Burning/Stinging Scores at Weeks 1, 2, 4, 8, 12/Withdrawal

    Itching and burning/stinging were evaluated by the participant as: 0 (none)=normal, no discomfort; 1 (slight)=noticeable discomfort that caused intermittent awareness; 2 (mild)=noticeable discomfort that caused continuous awareness; 3 (moderate)=noticeable discomfort that caused intermittent awareness and interfered occasionally with normal daily activities; 4 (severe)=definite continuous discomfort that interfered with normal daily activities. Change from Baseline was calculated as the post-Baseline/Withdrawal value minus the Baseline value.

    Measured: Baseline; Weeks 1, 2, 4, 8, 12 or withdrawal

Timeline

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

  1. First posted25 Jul 2011 (estimated)
  2. Study startJul 2011
  3. Primary completionApr 2012
  4. Study completionApr 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
Double blind
Who is masked
Participant, Investigator
Enrolment
360 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01400932
Sponsor's protocol ID
115288
Status last verified
May 2012
First submitted
21 Jul 2011
Last updated
5 Aug 2014
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GI148512 in people with Acne Vulgaris, run by GlaxoSmithKline at 19 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 16 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 5 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 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. Some participants in this study may receive a placebo. 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 5 Aug 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 Counts From Baseline to Week 12 (time frame: Baseline 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 NCT01400932.

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 5 Aug 2014.

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