Acne VulgarisPhase 1NCT04134273
Bio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris
A Phase 1 study testing CLPG Topical Gel 1% and Clindamycin in people with Acne Vulgaris, run by Sun Pharmaceutical Industries, Inc. at 1 site in United States.
Trial summary
This study is to evaluate the therapeutic equivalence and safety of Taro Product to RLD 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?
- CLPG Topical Gel 1% and Clindamycin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,260 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2019to 15 Oct 2019
- 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 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Healthy male or non-pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris
- Subjects who are 18 years of age or older (up to the age of 40) must have provided IRB approved written informed consent. Subjects 12 to 17 years of age, inclusive, must have provided IRB approved written assent; this written assent must be accompanied by an IRB approved written informed consent from the Subject's legally acceptable representative (i.e., parent or guardian).
- Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment (IGA).
Who cannot join
- Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
- Subjects with a known hypersensitivity to clindamycin or lincomycin and/or any ingredients in the study drugs.
- Subjects with the presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneiform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis).
Trial locations and contacts
1 site in 1 country.
United States1 site
Catawba Research, LLC
Charlotte, North Carolina, 28217
About this study
Official title: A Randomized, Double-Blind, Multiple Center Placebo Controlled Study Comparing Taro Product to RLD and Both Treatments to a Placebo Control in the Treatment of Acne Vulgaris.
This study is to evaluate the therapeutic equivalence and safety of Taro Product to RLD in the treatment of acne vulgaris.
Read the detailed description
The study objectives are to evaluate the therapeutic equivalence and safety of Taro Product to RLD in the treatment of acne vulgaris and to demonstrate the superiority of the efficacy of the test and reference products over the placebo control.
- Conditions
- Acne Vulgaris
- Being tested
- CLPG Topical Gel 1%, Clindamycin, Placebo
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLPG Topical Gel 1%Drug
Also called Topical Gel 1%
Clindamycin Phosphate Topical Gel 1% (Taro Pharmaceuticals U.S.A, Inc.)
ClindamycinDrug
Also called Topical Gel 1%
Clindamycin Phosphate topical gel 1%
PlaceboDrug
Also called Vehicle
Placebo (vehicle of the test product) (Taro Pharmaceuticals Inc.)
| Study group | Role | What they receive |
|---|---|---|
| CLPG Topical Gel 1% | Experimental | Clindamycin Phosphate Topical Gel 1%, applied to the face twice a day for 84 days. Receives: Drug: CLPG Topical Gel 1% |
| Clindamycin Phosphate Topical Gel 1% | Active comparator | Clindamycin Phosphate Topical Gel 1%, applied to the face twice a day for 84 days. Receives: Drug: Clindamycin |
| Vehicle of the test product | Placebo comparator | Placebo (vehicle of the test product), applied to the face twice a day for 84 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstration of Bioequivalence
Demonstration of Bioequivalence in percent change in inflammatory and non-inflammatory lesion counts.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2019
- Study start20 Mar 2019
- Primary completion17 Sep 2019
- Study completion15 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04134273
- Sponsor's protocol ID
- CLPG 1809
- Status last verified
- Oct 2019
- First submitted
- 18 Oct 2019
- Last updated
- 22 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Multiple Center Placebo Controlled Study Comparing Taro Product to RLD and Both Treatments to a Placebo Control in the Treatment of Acne Vulgaris.
- ClinicalTrials.gov ID
- NCT04134273
- Acronym / sponsor ID
- CLPG 1809
- Conditions
- Acne Vulgaris
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,260 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 17 Sep 2019 (actual)
- Study completion
- 15 Oct 2019 (actual)
- First posted
- 22 Oct 2019 (actual)
- 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 is to evaluate the therapeutic equivalence and safety of Taro Product to RLD in the treatment of acne vulgaris.
Detailed description
The study objectives are to evaluate the therapeutic equivalence and safety of Taro Product to RLD in the treatment of acne vulgaris and to demonstrate the superiority of the efficacy of the test and reference products over the placebo control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CLPG Topical Gel 1% | Experimental | Drug: CLPG Topical Gel 1%Clindamycin Phosphate Topical Gel 1%, applied to the face twice a day for 84 days. |
| Clindamycin Phosphate Topical Gel 1% | Active comparator | Drug: ClindamycinClindamycin Phosphate Topical Gel 1%, applied to the face twice a day for 84 days. |
| Vehicle of the test product | Placebo comparator | Drug: PlaceboPlacebo (vehicle of the test product), applied to the face twice a day for 84 days. |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Healthy male or non-pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris
- Subjects who are 18 years of age or older (up to the age of 40) must have provided IRB approved written informed consent. Subjects 12 to 17 years of age, inclusive, must have provided IRB approved written assent; this written assent must be accompanied by an IRB approved written informed consent from the Subject's legally acceptable representative (i.e., parent or guardian).
- Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment (IGA).
Key exclusion criteria (3 listed)
- Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
- Subjects with a known hypersensitivity to clindamycin or lincomycin and/or any ingredients in the study drugs.
- Subjects with the presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneiform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis).
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 |
|---|---|---|
| CLPG Topical Gel 1%Also: Topical Gel 1%Clindamycin Phosphate Topical Gel 1% (Taro Pharmaceuticals U.S.A, Inc.) | Drug | CLPG Topical Gel 1% |
| ClindamycinAlso: Topical Gel 1%Clindamycin Phosphate topical gel 1% | Drug | Clindamycin Phosphate Topical Gel 1% |
| PlaceboAlso: VehiclePlacebo (vehicle of the test product) (Taro Pharmaceuticals Inc.) | Drug | Vehicle of the test product |
Primary outcome
Demonstration of Bioequivalence
Time frame: Week 12
Demonstration of Bioequivalence in percent change in inflammatory and non-inflammatory lesion counts.
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 22 Oct 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CLPG Topical Gel 1% and Clindamycin in people with Acne Vulgaris, run by Sun Pharmaceutical Industries, Inc. 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 3 inclusion and 3 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 22 Oct 2019. 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 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?
Demonstration of Bioequivalence (time frame: Week 12). 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 22 Oct 2019.