Skin DiseasesPhase 4NCT02052752
A Five Day Clinical Study to Examine the Effects of a Benzoyl Peroxide Treatment on Facial Acne Lesions
A Phase 4 study testing 3% Benzoyl Peroxide and Neutrogena Rapid Clear® in people with Skin Diseases, run by GlaxoSmithKline at 1 site in United States.
Trial summary
5 Day study to assess how quickly a topical acne product begins to work. Read more about this study
- Who is it for?
- Ages 12 to 45 years
- Conditions the study is for
- Skin Diseases
- What is being tested?
- 3% Benzoyl Peroxide and Neutrogena Rapid Clear®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to May 2014
- Phase
- Phase 4
- 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
- Capable of understanding and willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol specific procedures are performed.
- Fitzpatrick Skin Type I - V.
- Male or female aged from 12 to 45 years, inclusive, at time of consent.
- Mild to moderate facial acne vulgaris as determined by the Investigator, with a minimum of 10 inflammatory lesions (papules plus pustules, including nasal lesions) and a minimum of 10 non-inflammatory lesions (open and closed comedones, including nasal lesions).
- Three appropriate and evaluable target lesions, as judged by the Investigator.
- Able to complete the study and to comply with study instructions.
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- Sexually active females of childbearing potential participating in the study must agree to 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. Acceptable contraceptive methods include the following:
- Hormonal contraception, including oral, injectable, or implantable methods started at least 2 months prior to screening. If hormonal contraception was started less than 2 months prior to screening, then a form of nonhormonal contraception should be added until the third continuous month of hormonal contraception has been completed.
- Two forms of reliable nonhormonal contraception, to include the use of either an intrauterine device plus a reliable barrier method or 2 reliable barrier methods. Reliable barrier methods include condoms or diaphragms. A cervical cap is also a reliable barrier method, provided that the female participant 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. Participants with surgical sterilization, including tubal sterilization or partner's vasectomy, must use a form of nonhormonal contraception. A barrier method or sterilization plus spermicide is acceptable.
- Women 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.
Who cannot join
- Has any nodulocystic lesions at the baseline evaluation.
- Female who is pregnant, trying to become pregnant, or breastfeeding.
- Has active or chronic skin allergies.
- Has a history of acute or chronic disease that might interfere with or increase the risk of study participation.
- Had skin cancer treatment in preceding 12 months.
- Has damaged skin on facial areas (e.g., sunburn, tattoo, or scar).
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- Had any medical procedure (e.g., laser resurfacing, chemical peel, or plastic surgery) on facial areas in preceding 12 months.
- Had any cosmetic procedure (e.g., microdermabrasion) on facial areas within 8 weeks of the baseline visit.
- Has any dermatological disorder that in the opinion of the Investigator may interfere with the accurate evaluation of the participant's facial appearance.
- Received any investigational drug or procedure within 28 days of study day 1 or is scheduled to receive an investigational drug (other than the study products) or procedure during the study.
- Currently using any medication that in the opinion of the Investigator may affect the evaluation of the study products or place the participant at undue risk.
- Has a history of known or suspected intolerance to any of the ingredients of the study products (i.e., benzoyl peroxide).
- Considered unable or unlikely to attend the necessary visits.
- Has used non-steroidal anti-inflammatory drugs for the treatment of acne or for treatment durations longer than 7 days for any condition.
- Uses oil-based sunscreens or sunscreens containing active ingredients that may have an effect on acne.
- Has received treatment with estrogens (including oral, implanted, and topical contraceptives), androgens, or anti-androgenic agents for 12 weeks or less immediately prior to starting application of the study product. Participants who have been treated with estrogens, as described above, androgens, or anti-androgenic agents for more than 12 consecutive weeks prior to starting application of the study product are allowed to enroll as long as they do not expect to change dose, drug, or discontinue use during the study.
- Has used topical antibiotics on the face or use of systemic antibiotics within the previous 2 weeks.
- Has used topical anti-acne medications (e.g., BPO, azelaic acid, resorcinol, salicylates) within the previous 2 weeks.
- Has used topical corticosteroids on the face or systemic corticosteroids within the previous 4 weeks. Use of inhaled, intra-articular or intra-lesional steroids other than for facial acne is acceptable.
- Has used systemic retinoids within the previous 6 months or topical retinoids within the previous 6 weeks.
- Uses abradants, facials, peels containing glycolic or other acids; masks, washes or soaps containing BPO, salicylic acid, or sulfacetamide sodium; non-mild facial cleansers, or moisturizers that contain retinol, salicylic acid or α- or β-hydroxy acids.
- Uses medications known to exacerbate acne (e.g., mega-doses of vitamin D [>2000 IU/day] and vitamin B12 [>1 mg/day]; systemic steroids; androgens; haloperidol; halogens such as iodide and bromide; lithium; hydantoin; and phenobarbital).
- Has had any facial procedure (e.g., blue light, chemical or laser peel, microdermabrasion) performed by any practitioner within 4 weeks before the study started or during the course of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
GSK Investigational Site
High Point, North Carolina, 27262
About this study
Official title: A Randomized, Double-blinded Study to Evaluate the Ability of an Acne Treatment Product to Produce Visible Improvements in Acne Lesions Over a 5 Day Period of Once-daily Use
5 Day study to assess how quickly a topical acne product begins to work.
- Conditions
- Skin Diseases
- Being tested
- 3% Benzoyl Peroxide, 3% Benzoyl Peroxide Placebo, Neutrogena Rapid Clear®
- Medical subject headings
- Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3% Benzoyl PeroxideDrug
Test product contained 3% benzoyl peroxide in the form of a gel. It was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
3% Benzoyl Peroxide PlaceboDrug
The vehicle gel was similar to the test product except that it did not contain 3% benzoyl peroxide. The vehicle gel served as the negative control and was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
Neutrogena Rapid Clear®Drug
A commercial product containing 2% salicylic acid that reportedly improves acne lesions was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
| Study group | Role | What they receive |
|---|---|---|
| Test Product | Experimental | Test product contained 3% benzoyl peroxide in the form of a gel. It was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3. Receives: Drug: 3% Benzoyl Peroxide |
| Vehicle gel | Active comparator | The vehicle gel was similar to the test product except that it did not contain 3% benzoyl peroxide. The vehicle gel served as the negative control and was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3. Receives: Drug: 3% Benzoyl Peroxide Placebo |
| Positive control | Placebo comparator | A commercial product containing 2% salicylic acid that reportedly improves acne lesions was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3. Receives: Drug: Neutrogena Rapid Clear® |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Assess the Percentage Change in Acne Lesion Swelling (Height) of the Target Lesion for 3% Benzoyl Peroxide (BPO) Gel Test Product Relative to the Vehicle Gel After 4 Once-daily Applications.
The Investigator assessed and score each target lesion's swelling (elevation), elevation scores were the actual dimensions, i.e. the value in millimeters at the lesion's highest points. Percent change in height of all three target lesions were calculated and averaged for each participant. The average lesion height at baseline was calculated for each participant. An analysis of covariance (ANCOVA) was performed with average percentage change in target lesion height as the response variable, treatment group (3% BPO or vehicle) as a main effect, and average baseline target lesion height as a covariate. A greater reduction in the percentage change in height of the target lesions indicated a better outcome measure
Measured: Baseline to Day 4
Secondary outcomes (5)
To Assess the Percentage Change in Acne Lesion Swelling (Height) for the 3% Benzoyl Peroxide Gel Test Product and Positive Control Relative to the Vehicle Gel.
The Investigator assessed and score each target lesion's swelling (elevation), elevation scores were the actual dimensions, i.e. the value in millimeters at the lesion's highest points. Percent change in height of all three target lesions were calculated and averaged for each participant. The average lesion height at baseline was calculated for each participant
Measured: Baseline to 2 hours, 4 hours, Day 1, Day 2 and Day 4
To Assess the Change in Acne Lesion Redness (Erythema) for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel.
The investigator assessed the erythema of the target lesion according to the following scale and tabulated the responses: 0=none, 1=minimal, 2=mild, 3=-moderate, 4=severe.
Measured: Baseline to 2 hours, 4 hours, Day 1, Day 2, and Day 4
To Assess the Percentage Change in Acne Lesion Diameter (Size) for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel.
The Investigator assessed and score each target lesion's diameter (size). Diameter scores were the actual dimensions, i.e. the value in millimeters at the lesion's widest or highest points.
Measured: Baseline to 2 hours, 4 hours, Day 1, Day 2, and Day 4
To Assess the Change in Facial Skin Clarity for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel
The Skin clarity was measured using the following scale; 0 Very Clear; 1 Clear; 2 Dull; 3 Very Dull; 4 Unclear. The responses were then tabulated
Measured: Baseline to 2 hours, 4 hours, Day 1, Day 2, and Day 4
To Assess the Change in Perceptions of the Overall Appearance of Their Skin for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel
The participants were asked to rate the overall appearance of their facial skin as; 1= Very Dissatisfied; 2= Slightly Dissatisfied; 3= Neither Satisfied nor Dissatisfied; 4= Slightly Satisfied; 5= Very Satisfied. The responses were then tabulated.
Measured: Baseline to 2 hours, 4 hours, Day 1, Day 2, and Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionMay 2014
- Study completionMay 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.
- Other trials for Skin DiseasesStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 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
- NCT02052752
- Sponsor's protocol ID
- 201244
- Other IDs
- RH02060
- Status last verified
- May 2015
- First submitted
- 30 Jan 2014
- Last updated
- 18 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blinded Study to Evaluate the Ability of an Acne Treatment Product to Produce Visible Improvements in Acne Lesions Over a 5 Day Period of Once-daily Use
- ClinicalTrials.gov ID
- NCT02052752
- Acronym / sponsor ID
- 201244
- Conditions
- Skin Diseases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 3 Feb 2014 (estimated)
- Results
- Posted 18 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
5 Day study to assess how quickly a topical acne product begins to work.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test Product | Experimental | Drug: 3% Benzoyl PeroxideTest product contained 3% benzoyl peroxide in the form of a gel. It was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3. |
| Vehicle gel | Active comparator | Drug: 3% Benzoyl Peroxide PlaceboThe vehicle gel was similar to the test product except that it did not contain 3% benzoyl peroxide. The vehicle gel served as the negative control and was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3. |
| Positive control | Placebo comparator | Drug: Neutrogena Rapid Clear®A commercial product containing 2% salicylic acid that reportedly improves acne lesions was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3. |
Who may qualify
- Ages
- 12 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Capable of understanding and willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol specific procedures are performed.
- Fitzpatrick Skin Type I - V.
- Male or female aged from 12 to 45 years, inclusive, at time of consent.
- Mild to moderate facial acne vulgaris as determined by the Investigator, with a minimum of 10 inflammatory lesions (papules plus pustules, including nasal lesions) and a minimum of 10 non-inflammatory lesions (open and closed comedones, including nasal lesions).
- Three appropriate and evaluable target lesions, as judged by the Investigator.
Key exclusion criteria (23 listed)
- Has any nodulocystic lesions at the baseline evaluation.
- Female who is pregnant, trying to become pregnant, or breastfeeding.
- Has active or chronic skin allergies.
- Has a history of acute or chronic disease that might interfere with or increase the risk of study participation.
- Had skin cancer treatment in preceding 12 months.
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 |
|---|---|---|
| 3% Benzoyl PeroxideTest product contained 3% benzoyl peroxide in the form of a gel. It was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3. | Drug | Test Product |
| 3% Benzoyl Peroxide PlaceboThe vehicle gel was similar to the test product except that it did not contain 3% benzoyl peroxide. The vehicle gel served as the negative control and was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3. | Drug | Vehicle gel |
| Neutrogena Rapid Clear®A commercial product containing 2% salicylic acid that reportedly improves acne lesions was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3. | Drug | Positive control |
Primary outcome
To Assess the Percentage Change in Acne Lesion Swelling (Height) of the Target Lesion for 3% Benzoyl Peroxide (BPO) Gel Test Product Relative to the Vehicle Gel After 4 Once-daily Applications.
Time frame: Baseline to Day 4
The Investigator assessed and score each target lesion's swelling (elevation), elevation scores were the actual dimensions, i.e. the value in millimeters at the lesion's highest points. Percent change in height of all three target lesions were calculated and averaged for each participant. The average lesion height at baseline was calculated for each participant. An analysis of covariance (ANCOVA) was performed with average percentage change in target lesion height as the response variable, treatment group (3% BPO or vehicle) as a main effect, and average baseline target lesion height as a covariate. A greater reduction in the percentage change in height of the target lesions indicated a better outcome measure
5 secondary outcomes
To Assess the Percentage Change in Acne Lesion Swelling (Height) for the 3% Benzoyl Peroxide Gel Test Product and Positive Control Relative to the Vehicle Gel.
Time frame: Baseline to 2 hours, 4 hours, Day 1, Day 2 and Day 4
To Assess the Change in Acne Lesion Redness (Erythema) for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel.
Time frame: Baseline to 2 hours, 4 hours, Day 1, Day 2, and Day 4
To Assess the Percentage Change in Acne Lesion Diameter (Size) for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel.
Time frame: Baseline to 2 hours, 4 hours, Day 1, Day 2, and Day 4
To Assess the Change in Facial Skin Clarity for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel
Time frame: Baseline to 2 hours, 4 hours, Day 1, Day 2, and Day 4
To Assess the Change in Perceptions of the Overall Appearance of Their Skin for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel
Time frame: Baseline to 2 hours, 4 hours, Day 1, Day 2, and Day 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 3% Benzoyl Peroxide and Neutrogena Rapid Clear® in people with Skin Diseases, run by GlaxoSmithKline at 1 site 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 10 inclusion and 23 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 18 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 18 May 2015). 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?
To Assess the Percentage Change in Acne Lesion Swelling (Height) of the Target Lesion for 3% Benzoyl Peroxide (BPO) Gel Test Product Relative to the Vehicle Gel After 4 Once-daily Applications. (time frame: Baseline to Day 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 May 2015.