Acne VulgarisPhase 3NCT03717506
Bioequivalence Study of Clindamycin Phosphate Topical Lotion, 1% in Subjects With Acne Vulgaris
A Phase 3 study testing GDC 268 Lotion and Clindamycin Phosphate Lotion 1% in people with Acne Vulgaris, run by Balmoral Medical company at 34 sites in United States.
Trial summary
The objective of the study is to evaluate the safety, tolerability, and therapeutic equivalence of GDC 268 to Clindamycin Phosphate Topical Lotion, 1% and to compare the efficacy of these two products to the GDC vehicle lotion (i.e., placebo) in the treatment of acne vulgaris. Read more about this study
- Who is it for?
- Ages 12 to 40 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- GDC 268 Lotion and Clindamycin Phosphate Lotion 1%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,236 participants
- Where
- 34 sitesUnited States
- Study dates
- 10 Oct 2018to 16 Apr 2020
- 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 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male or non-pregnant, non-lactating female, ≥12 and ≤40 years of age with a clinical diagnosis of acne vulgaris.
- Must have ≥ 25 but ≤ 100 non-inflammatory lesions (open and closed comedones) AND ≥ 20 but ≤ 70 inflammatory lesions (papules and pustules) AND ≤ 2 nodulocystic lesions (nodules and cysts) on the face (e.g., forehead, nose, cheeks, chin, upper lip) at Baseline.
- Must be willing and able to refrain from use of all other topical products in the treatment area, all acne medications other than test article, and all antibiotics (other than test article) during the 12-week treatment period.
- Women must be surgically sterile, or use an effective method of birth control with a negative urine pregnancy test (UPT) at the Baseline Visit (Day 1).
- In good general health and free of any other clinically significant disease state or physical condition.
- Subject has provided written informed consent / assent.
Who cannot join
- Subject is pregnant, breastfeeding, or is planning to become pregnant or breastfeed during the study.
- Subject has more than 2 facial nodular lesions; any nodules present will be documented but not included in the inflammatory lesion count for analysis.
- Subject has excessive facial hair (e.g., beards, sideburns, moustaches), facial tattoos, or other facial attributes that would interfere with diagnosis or assessment of acne vulgaris in the opinion of the investigator.
- Subject is planning surgery during the study.
- Subject has a history of hypersensitivity or allergy to clindamycin or lincomycin and/or any of the ingredients in the test articles.
- Other Eligibility Criteria not listed above will be reviewed for each prospective subject by the study staff.
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
United States34 sites
Site 08
Anderson, South Carolina, 29621
Site 44
Aventura, Florida, 33180
Site 09
Boise, Idaho, 83704
Site 36
Brandon, Florida, 33511
Site 29
Chattanooga, Tennessee, 37421
Site 28
Clarkston, Michigan, 48346
Site 45
DeLand, Florida, 32720
Site 19
Dublin, Ohio, 43016
Site 07
Fort Smith, Arkansas, 72916
Site 25
Fountain Valley, California, 92708
Site 24
Fridley, Minnesota, 55432
Site 17
Gresham, Oregon, 97030
Site 06
High Point, North Carolina, 27262
Site 41
Largo, Florida, 33770
Site 38
Miami, Florida, 33145
Site 35
Miami Lakes, Florida, 33014
Site 03
Murfreesboro, Tennessee, 37130
Site 04
Nashville, Tennessee, 37215
Site 10
Newnan, Georgia, 30263
Site 37
North Miami Beach, Florida, 33162
Site 33
Northridge, California, 91324
Site 49
Omaha, Nebraska, 68134
Site 27
Overland Park, Kansas, 66215
Site 34
Philadelphia, Pennsylvania, 19103
Site 02
Plainfield, Indiana, 46168
Site 32
Raleigh, North Carolina, 27612
Site 22
Rogers, Arkansas, 72758
Site 05
Rolling Meadows, Illinois, 60008
Site 30
San Diego, California, 92103
Site 26
St. Petersburg, Florida, 33709
Site 43
Sugar Land, Texas, 77479
Site 42
Tampa, Florida, 33609
Site 20
Warwick, Rhode Island, 02886
Site 01
West Palm Beach, Florida, 33406
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study to Determine the Therapeutic Equivalence of GDC 268 and Clindamycin Phosphate Topical Lotion, 1% in Subjects With Acne Vulgaris
The objective of the study is to evaluate the safety, tolerability, and therapeutic equivalence of GDC 268 to Clindamycin Phosphate Topical Lotion, 1% and to compare the efficacy of these two products to the GDC vehicle lotion (i.e., placebo) in the treatment of acne vulgaris.
- Conditions
- Acne Vulgaris
- Being tested
- GDC 268 Lotion, Clindamycin Phosphate Lotion 1%, GDC Vehicle Lotion
- Keywords
- zits, pimples, blackheads
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GDC 268 LotionDrug
GDC 268 is a topical lotion
Clindamycin Phosphate Lotion 1%Drug
Clindamycin Phosphate Lotion is an FDA-approved drug product
GDC Vehicle LotionDrug
GDC Vehicle Lotion contains 0.0% of active drug and is matched to the other two active test drugs
| Study group | Role | What they receive |
|---|---|---|
| Test product | Experimental | GDC 268 Lotion applied topically as directed. Receives: Drug: GDC 268 Lotion |
| Reference Product | Active comparator | Clindamycin Phosphate Lotion, 1% applied topically as directed. Receives: Drug: Clindamycin Phosphate Lotion 1% |
| Placebo | Placebo comparator | GDC Vehicle lotion applied topically as directed. Receives: Drug: GDC Vehicle Lotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Percent Change in the Number of Inflamed Lesions
Percent Change from Baseline to Week 12 in inflammatory lesion counts (Papules/Pustules).
Measured: 12 weeks
Mean Percent Change in the Non-inflammatory Lesion Counts
Percent Change (i.e., reduction) from Baseline to Week 12 in non-inflammatory (open and closed comedones) lesion counts.
Measured: 12 weeks
Secondary outcomes (1)
The Percentage of Subjects With a Clinical Response (IGA) of "Success" at Week 12
Investigator's Global Assessment, IGA. Overall severity of acne was assessed using a five-point scale from 0=Clear to 4=Severe. Subjects must have had an IGA score of 2 (mild), 3 (moderate), or 4 (severe) at Baseline. Success is defined as an IGA score at week 12 that is at least 2 grades less than the baseline assessment.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2018
- Study start10 Oct 2018
- Primary completion17 Feb 2020
- Study completion16 Apr 2020
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 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balmoral Medical company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03717506
- Sponsor's protocol ID
- GDC-268-001
- Status last verified
- Apr 2021
- First submitted
- 22 Oct 2018
- Last updated
- 4 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study to Determine the Therapeutic Equivalence of GDC 268 and Clindamycin Phosphate Topical Lotion, 1% in Subjects With Acne Vulgaris
- ClinicalTrials.gov ID
- NCT03717506
- Acronym / sponsor ID
- GDC-268-001
- Conditions
- Acne Vulgaris
- Keywords
- zits, pimples, blackheads
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,236 participants (actual)
- Lead sponsor
- Balmoral Medical companyIndustry (pharma, biotech, devices)
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 17 Feb 2020 (actual)
- Study completion
- 16 Apr 2020 (actual)
- First posted
- 24 Oct 2018 (actual)
- Results
- Posted 4 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to evaluate the safety, tolerability, and therapeutic equivalence of GDC 268 to Clindamycin Phosphate Topical Lotion, 1% and to compare the efficacy of these two products to the GDC vehicle lotion (i.e., placebo) in the treatment of acne vulgaris.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test product | Experimental | Drug: GDC 268 LotionGDC 268 Lotion applied topically as directed. |
| Reference Product | Active comparator | Drug: Clindamycin Phosphate Lotion 1%Clindamycin Phosphate Lotion, 1% applied topically as directed. |
| Placebo | Placebo comparator | Drug: GDC Vehicle LotionGDC Vehicle lotion applied topically as directed. |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Male or non-pregnant, non-lactating female, ≥12 and ≤40 years of age with a clinical diagnosis of acne vulgaris.
- Must have ≥ 25 but ≤ 100 non-inflammatory lesions (open and closed comedones) AND ≥ 20 but ≤ 70 inflammatory lesions (papules and pustules) AND ≤ 2 nodulocystic lesions (nodules and cysts) on the face (e.g., forehead, nose, cheeks, chin, upper lip) at Baseline.
- Must be willing and able to refrain from use of all other topical products in the treatment area, all acne medications other than test article, and all antibiotics (other than test article) during the 12-week treatment period.
- Women must be surgically sterile, or use an effective method of birth control with a negative urine pregnancy test (UPT) at the Baseline Visit (Day 1).
- In good general health and free of any other clinically significant disease state or physical condition.
Key exclusion criteria (6 listed)
- Subject is pregnant, breastfeeding, or is planning to become pregnant or breastfeed during the study.
- Subject has more than 2 facial nodular lesions; any nodules present will be documented but not included in the inflammatory lesion count for analysis.
- Subject has excessive facial hair (e.g., beards, sideburns, moustaches), facial tattoos, or other facial attributes that would interfere with diagnosis or assessment of acne vulgaris in the opinion of the investigator.
- Subject is planning surgery during the study.
- Subject has a history of hypersensitivity or allergy to clindamycin or lincomycin and/or any of the ingredients in the test articles.
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 |
|---|---|---|
| GDC 268 LotionGDC 268 is a topical lotion | Drug | Test product |
| Clindamycin Phosphate Lotion 1%Clindamycin Phosphate Lotion is an FDA-approved drug product | Drug | Reference Product |
| GDC Vehicle LotionGDC Vehicle Lotion contains 0.0% of active drug and is matched to the other two active test drugs | Drug | Placebo |
Primary outcome
Mean Percent Change in the Number of Inflamed Lesions
Time frame: 12 weeks
Percent Change from Baseline to Week 12 in inflammatory lesion counts (Papules/Pustules).
Mean Percent Change in the Non-inflammatory Lesion Counts
Time frame: 12 weeks
Percent Change (i.e., reduction) from Baseline to Week 12 in non-inflammatory (open and closed comedones) lesion counts.
1 secondary outcome
The Percentage of Subjects With a Clinical Response (IGA) of "Success" at Week 12
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GDC 268 Lotion and Clindamycin Phosphate Lotion 1% in people with Acne Vulgaris, run by Balmoral Medical company at 34 sites 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 6 inclusion and 6 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 4 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites 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 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 4 May 2021). 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?
Mean Percent Change in the Number of Inflamed Lesions (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 4 May 2021.