Acne VulgarisPhase 1NCT01132443
W0261-101: A Phase 1, Single Center, Randomized, Open-Label Study to Evaluate the Bioavailability of Clindamycin From Clindamycin 1%-Benzoyl Peroxide 3% Gel, Topical Gel (Clindamycin 1%- Benzoyl Peroxide 5%), and Once Daily Gel (Clindamycin 1%-Benzoyl Peroxide 5%) in Subjects With Acne
A Phase 1 study testing Clindamycin 1%-Benzoyl Peroxide (BPO) 3% Gel, in people with Acne Vulgaris, run by Stiefel, a GSK Company.
Trial summary
This study was conducted to determine if the bioavailability of clindamycin and its metabolite clindamycin sulfoxide are altered by the concentration of BPO or the absence of methylparaben. 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?
- Clindamycin 1%-Benzoyl Peroxide (BPO) 3% Gel,
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 6 May 2010to 12 Jun 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 HIPAA authorization) before any protocol-specific procedures were performed. Subjects under the legal age of consent in the state where the study was conducted must have provided assent and have had the written informed consent of a parent or guardian.
- Male or female 12 to 45 years of age at time of consent.
- Moderate-to-severe facial acne, defined as an ISGA score of 3 or greater.
- Able to complete the study and to comply with study instructions.
- Sexually-active females of childbearing potential participating in the study must have agreed to use a medically-acceptable method of contraception while receiving protocol-assigned product. A woman of childbearing potential was 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 included the following:
- Hormonal contraception, including oral, injectable, or implantable methods started at least 3 months prior to screening. If hormonal contraception was started less than 3 months prior to screening, then a form of nonhormonal contraception should have been added until the third continuous month of hormonal contraception had 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 the female subject has never given birth vaginally. 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 sterilization or partner's vasectomy, must have used a form of nonhormonal contraception. A barrier method or sterilization plus spermicide was acceptable.
- Women who were not currently sexually active must have agreed to use a medically-acceptable method of contraception should they have become sexually active while participating in the study.
Who cannot join
- Female who was pregnant, trying to become pregnant, or breast feeding.
- Participation in any investigational study within 4 weeks of Day 1 or who were scheduled to participate in another investigational study in the next 2 weeks.
- Used prohibited medications within specified time period before Day 1.
- Currently using any medication that, in the opinion of the investigator, may affect the evaluation of the study product or place the subject at undue risk.
- History or evidence of skin conditions other than acne (eg, eczema, rosacea, seborrheic dermatitis, birthmarks, tattoos) that would interfere with study evaluations.
- History or presence of regional enteritis or inflammatory bowel disease (eg, ulcerative colitis, pseudomembranous colitis, chronic diarrhea, celiac disease, Crohn's disease, or history of antibiotic-associated colitis) or similar symptoms.
Show all 20Show fewer
- Had any major illness within 4 weeks of Day 1.
- Anticipated need for surgery or hospitalization during the study.
- Blood donation, or equivalent blood loss (~480 mL), within 3 months of Day 1.
- Anemia or any other systemic disease condition for which a loss of 120 mL of blood over a 1-week period may put the subject at undue risk.
- Considered immunocompromised.
- Currently suffering from any disease or condition that, in the opinion of the investigator, may affect the evaluation of the study product or place the subject at undue risk.
- Current smoker or smoker with less than 4 weeks abstinence from smoking and nicotine-containing products.
- Anticipated need to engage in activities or exercise that would cause profuse sweating during the study.
- Required or desired excessive or prolonged exposure to ultraviolet light (eg, sunlight, or tanning beds) during the study.
- Clinically relevant history of or current evidence of abuse of alcohol or other drugs.
- History of known or suspected intolerance, hypersensitivity, or allergic reaction to any of the ingredients of the study products, including clindamycin and BPO.
- Considered unable or unlikely to attend the necessary visits.
- Lived in the same household as currently enrolled subjects.
- Employee of the investigator, clinical research organization, or Stiefel who was involved in the study, or an immediate family member (eg, partner, offspring, parents, siblings, or sibling's offspring) of an employee who was involved in the study.
About this study
Official title: A Phase 1, Single Center, Randomized, Open-Label Study to Evaluate the Bioavailability of Clindamycin From Clindamycin 1%-Benzoyl Peroxide 3% Gel, Topical Gel (Clindamycin 1%- Benzoyl Peroxide 5%), and Once Daily Gel (Clindamycin 1%-Benzoyl Peroxide 5%) in Subjects With Acne Vulgaris
This study was conducted to determine if the bioavailability of clindamycin and its metabolite clindamycin sulfoxide are altered by the concentration of BPO or the absence of methylparaben. This study compared the investigational study product and 2 marketed products:
- CLN 1%-BPO 3% Gel (clindamycin 1%-BPO 3%), methylparaben-free
- Topical Gel (clindamycin 1%-BPO 5%), methylparaben-preserved (Topical Gel-MP)
- Once Daily Gel ((clindamycin 1%-BPO 5%), methylparaben-free (Topical Gel-MPF)
Read the detailed description
Clindamycin and benzoyl peroxide (BPO) are both well-known treatments for acne vulgaris (acne) and are available as single-entity and fixed-dose combination products. The same excipients are used in the gel vehicle formulations, except inclusion of the preservative methylparaben in the vehicle is dependent on geographic region. While these products have been shown to be well tolerated, effective combination therapies for acne, concentration-dependent cutaneous irritation has been associated with the use of BPO.
Clindamycin 1%-benzoyl peroxide 3% gel (CLN 1%-BPO 3%) for the topical treatment of acne was developed. CLN 1%-BPO 3% contains the same concentration of clindamycin and a lower concentration of BPO than currently-marketed products, and CLN 1%-BPO 3% is formulated without methylparaben.
A study to evaluate the plasma concentrations of clindamycin and its metabolites after topical gel was applied once daily for 4 weeks in subjects with moderate-to-severe acne showed that the absorption of clindamycin and its metabolite clindamycin sulfoxide were comparable between Topical Gel and a representative single entity product with the same clindamycin concentration. An in vitro skin penetration study demonstrated that there were no significant differences in the delivery of clindamycin in and through the skin following application of either CLN 1%-BPO 3% or topical gel; therefore, the presence of BPO in the formulation at either 3% or 5% did not have an effect on the percutaneous absorption of clindamycin.
Benzoyl peroxide has been shown to be absorbed by the skin where it is converted to benzoic acid. Following topical application, less than 2% of the dose enters systemic circulation as benzoic acid. The transepidermal delivery of BPO is dependent on concentration and no systemic toxicity is expected due to rapid renal clearance of benzoic acid. Benzoic acid is frequently utilized as a preservative or to adjust the pH in food, cosmetics, and medicinal products; therefore, the limited systemic absorption from CLN 1%-BPO 3% is not expected to notably increase exposure to benzoic acid. Due to the low potential for systemic toxicity and the limited utility of assessing plasma concentrations of benzoic acid, the systemic exposure was not evaluated in this study.
Systemic exposure to clindamycin has been associated with severe cases of diarrhea, bloody diarrhea and colitis (including pseudomembranous colitis), which could be fatal. Several studies conducted with single-entity and fixed-combination topical clindamycin-containing products have determined that systemic absorption of clindamycin is low; however, there have been documented cases of colitis after topical administration of clindamycin phosphate. Clindamycin phosphate is rapidly hydrolyzed in vivo to clindamycin, the active parent compound. Topical application of Clindagel (clindamycin phosphate 1% gel) equivalent to 3 to 12 grams once daily for 5 days resulted in peak plasma clindamycin concentrations that were less than 5.5ng/mL. Multiple topical applications of Cleocin T (clindamycin phosphate at a concentration equivalent to 10mg/mL) resulted in clindamycin serum levels ranging from 0 to 3 ng/mL. The mean systemic bioavailability of clindamycin is less than 1%.
As there exists a potential for different topical formulations to have greater systemic exposure to the active ingredients than currently marketed products, this study was conducted to determine if the bioavailability of clindamycin and its metabolite clindamycin sulfoxide are altered by the concentration of BPO or the absence of methylparaben. This study compared the investigational study product and 2 marketed products:
- CLN 1%-BPO 3% Gel (clindamycin 1%-BPO 3%), methylparaben-free
- Topical Gel (clindamycin 1%-BPO 5%), methylparaben-preserved (Topical Gel-MP)
- Once Daily Gel ((clindamycin 1%-BPO 5%), methylparaben-free (Topical Gel-MPF)
- Conditions
- Acne Vulgaris
- Being tested
- Clindamycin 1%-Benzoyl Peroxide (BPO) 3% 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.
Clindamycin 1%-Benzoyl Peroxide (BPO) 3% Gel,Drug
Apply topically once daily
| Study group | Role | What they receive |
|---|---|---|
| Clindamycin 1%-Benzoyl Peroxide (BPO) 3% Gel, | Experimental | Apply topically once daily; clindamycin (CLN); benzoyl peroxide (BPO); methylparaben-free (MPF) Receives: Drug: Clindamycin 1%-Benzoyl Peroxide (BPO) 3% Gel, |
| Duac/ formulation 1 | Active comparator | Apply topically once daily, Topical Gel (CLN 1%-BPO 5%), methylparaben-preserved Receives: Drug: Clindamycin 1%-Benzoyl Peroxide (BPO) 3% Gel, |
| Duac/ formulation 2 | Active comparator | Apply topically once daily, Duac Once Daily Gel (CLN 1%-BPO 5%), MPF Receives: Drug: Clindamycin 1%-Benzoyl Peroxide (BPO) 3% Gel, |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clindamycin plasma concentrations
Plasma concentrations of clindamycin in subjects with acne vulgaris
Measured: Baseline to Day 6
Secondary outcomes (1)
Clindamycin sulfoxide plasma concentrations
Plasma concentrations of clindamycin sulfoxide in subjects with acne vulgaris
Measured: Baseline/Day 1, Day 2, 3, 4, and 5 (pre-dose and 1, 2, 4, 6, 8, 12, and 24 hours post dost - Day 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2010 (estimated)
- Study start6 May 2010
- Primary completion12 Jun 2010
- Study completion12 Jun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stiefel, a GSK Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01132443
- Sponsor's protocol ID
- 115902
- Status last verified
- Jun 2017
- First submitted
- 24 May 2010
- Last updated
- 16 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
Jones TM, Jasper S, Alio Saenz AB. Bioavailability of Clindamycin From a New Clindamycin Phosphate 1.2%-Benzoyl Peroxide 3% Combination Gel. Clin Pharmacol Drug Dev. 2013 Jan;2(1):33-47. doi: 10.1002/cpdd.7. Epub 2013 Mar 4.
PubMed 27121558
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single Center, Randomized, Open-Label Study to Evaluate the Bioavailability of Clindamycin From Clindamycin 1%-Benzoyl Peroxide 3% Gel, Topical Gel (Clindamycin 1%- Benzoyl Peroxide 5%), and Once Daily Gel (Clindamycin 1%-Benzoyl Peroxide 5%) in Subjects With Acne Vulgaris
- ClinicalTrials.gov ID
- NCT01132443
- Acronym / sponsor ID
- 115902
- Conditions
- Acne Vulgaris
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Stiefel, a GSK CompanyIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- 6 May 2010 (actual)
- Primary completion
- 12 Jun 2010 (actual)
- Study completion
- 12 Jun 2010 (actual)
- First posted
- 28 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was conducted to determine if the bioavailability of clindamycin and its metabolite clindamycin sulfoxide are altered by the concentration of BPO or the absence of methylparaben. This study compared the investigational study product and 2 marketed products:
- CLN 1%-BPO 3% Gel (clindamycin 1%-BPO 3%), methylparaben-free
- Topical Gel (clindamycin 1%-BPO 5%), methylparaben-preserved (Topical Gel-MP)
- Once Daily Gel ((clindamycin 1%-BPO 5%), methylparaben-free (Topical Gel-MPF)
Detailed description
Clindamycin and benzoyl peroxide (BPO) are both well-known treatments for acne vulgaris (acne) and are available as single-entity and fixed-dose combination products. The same excipients are used in the gel vehicle formulations, except inclusion of the preservative methylparaben in the vehicle is dependent on geographic region. While these products have been shown to be well tolerated, effective combination therapies for acne, concentration-dependent cutaneous irritation has been associated with the use of BPO.
Clindamycin 1%-benzoyl peroxide 3% gel (CLN 1%-BPO 3%) for the topical treatment of acne was developed. CLN 1%-BPO 3% contains the same concentration of clindamycin and a lower concentration of BPO than currently-marketed products, and CLN 1%-BPO 3% is formulated without methylparaben.
A study to evaluate the plasma concentrations of clindamycin and its metabolites after topical gel was applied once daily for 4 weeks in subjects with moderate-to-severe acne showed that the absorption of clindamycin and its metabolite clindamycin sulfoxide were comparable between Topical Gel and a representative single entity product with the same clindamycin concentration. An in vitro skin penetration study demonstrated that there were no significant differences in the delivery of clindamycin in and through the skin following application of either CLN 1%-BPO 3% or topical gel; therefore, the presence of BPO in the formulation at either 3% or 5% did not have an effect on the percutaneous absorption of clindamycin.
Benzoyl peroxide has been shown to be absorbed by the skin where it is converted to benzoic acid. Following topical application, less than 2% of the dose enters systemic circulation as benzoic acid. The transepidermal delivery of BPO is dependent on concentration and no systemic toxicity is expected due to rapid renal clearance of benzoic acid. Benzoic acid is frequently utilized as a preservative or to adjust the pH in food, cosmetics, and medicinal products; therefore, the limited systemic absorption from CLN 1%-BPO 3% is not expected to notably increase exposure to benzoic acid. Due to the low potential for systemic toxicity and the limited utility of assessing plasma concentrations of benzoic acid, the systemic exposure was not evaluated in this study.
Systemic exposure to clindamycin has been associated with severe cases of diarrhea, bloody diarrhea and colitis (including pseudomembranous colitis), which could be fatal. Several studies conducted with single-entity and fixed-combination topical clindamycin-containing products have determined that systemic absorption of clindamycin is low; however, there have been documented cases of colitis after topical administration of clindamycin phosphate. Clindamycin phosphate is rapidly hydrolyzed in vivo to clindamycin, the active parent compound. Topical application of Clindagel (clindamycin phosphate 1% gel) equivalent to 3 to 12 grams once daily for 5 days resulted in peak plasma clindamycin concentrations that were less than 5.5ng/mL. Multiple topical applications of Cleocin T (clindamycin phosphate at a concentration equivalent to 10mg/mL) resulted in clindamycin serum levels ranging from 0 to 3 ng/mL. The mean systemic bioavailability of clindamycin is less than 1%.
As there exists a potential for different topical formulations to have greater systemic exposure to the active ingredients than currently marketed products, this study was conducted to determine if the bioavailability of clindamycin and its metabolite clindamycin sulfoxide are altered by the concentration of BPO or the absence of methylparaben. This study compared the investigational study product and 2 marketed products:
- CLN 1%-BPO 3% Gel (clindamycin 1%-BPO 3%), methylparaben-free
- Topical Gel (clindamycin 1%-BPO 5%), methylparaben-preserved (Topical Gel-MP)
- Once Daily Gel ((clindamycin 1%-BPO 5%), methylparaben-free (Topical Gel-MPF)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Clindamycin 1%-Benzoyl Peroxide (BPO) 3% Gel, | Experimental | Drug: Clindamycin 1%-Benzoyl Peroxide (BPO) 3% Gel,Apply topically once daily; clindamycin (CLN); benzoyl peroxide (BPO); methylparaben-free (MPF) |
| Duac/ formulation 1 | Active comparator | Drug: Clindamycin 1%-Benzoyl Peroxide (BPO) 3% Gel,Apply topically once daily, Topical Gel (CLN 1%-BPO 5%), methylparaben-preserved |
| Duac/ formulation 2 | Active comparator | Drug: Clindamycin 1%-Benzoyl Peroxide (BPO) 3% Gel,Apply topically once daily, Duac Once Daily Gel (CLN 1%-BPO 5%), MPF |
Who may qualify
- Ages
- 12 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Capable of understanding and willing to provide signed and dated written voluntary informed consent (and HIPAA authorization) before any protocol-specific procedures were performed. Subjects under the legal age of consent in the state where the study was conducted must have provided assent and have had the written informed consent of a parent or guardian.
- Male or female 12 to 45 years of age at time of consent.
- Moderate-to-severe facial acne, defined as an ISGA score of 3 or greater.
- Able to complete the study and to comply with study instructions.
- Sexually-active females of childbearing potential participating in the study must have agreed to use a medically-acceptable method of contraception while receiving protocol-assigned product. A woman of childbearing potential was 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 included the following:
Key exclusion criteria (20 listed)
- Female who was pregnant, trying to become pregnant, or breast feeding.
- Participation in any investigational study within 4 weeks of Day 1 or who were scheduled to participate in another investigational study in the next 2 weeks.
- Used prohibited medications within specified time period before Day 1.
- Currently using any medication that, in the opinion of the investigator, may affect the evaluation of the study product or place the subject at undue risk.
- History or evidence of skin conditions other than acne (eg, eczema, rosacea, seborrheic dermatitis, birthmarks, tattoos) that would interfere with study evaluations.
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 |
|---|---|---|
| Clindamycin 1%-Benzoyl Peroxide (BPO) 3% Gel,Apply topically once daily | Drug | Clindamycin 1%-Benzoyl Peroxide (BPO) 3% Gel,, Duac/ formulation 1, Duac/ formulation 2 |
Primary outcome
Clindamycin plasma concentrations
Time frame: Baseline to Day 6
Plasma concentrations of clindamycin in subjects with acne vulgaris
1 secondary outcome
Clindamycin sulfoxide plasma concentrations
Time frame: Baseline/Day 1, Day 2, 3, 4, and 5 (pre-dose and 1, 2, 4, 6, 8, 12, and 24 hours post dost - Day 6)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2017.
- Background: PubMed 27121558Jones TM, Jasper S, Alio Saenz AB. Bioavailability of Clindamycin From a New Clindamycin Phosphate 1.2%-Benzoyl Peroxide 3% Combination Gel. Clin Pharmacol Drug Dev. 2013 Jan;2(1):33-47. doi: 10.1002/cpdd.7. Epub 2013 Mar 4.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Results for study 115902 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Clindamycin 1%-Benzoyl Peroxide (BPO) 3% Gel, in people with Acne Vulgaris, run by Stiefel, a GSK Company.
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 20 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 16 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clindamycin plasma concentrations (time frame: Baseline to Day 6). 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 NCT01132443, 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 16 Jun 2017.