Acne VulgarisPhase 2NCT03341910
A Study to Assess the Safety and Local Tolerability of DFD-03 (Tazarotene) Lotion, 0.1% Compared to Tazorac® Cream, 0.1% in the Topical Treatment of Acne Vulgaris
A Phase 2 study testing DFD-03 Lotion, 0.1% and Tazorac Cream, 0.1% in people with Acne Vulgaris, run by Dr. Reddy's Laboratories Limited at 1 site in United States.
Trial summary
A study for Subjects with mild to moderate facial acne vulgaris. During the 12-week treatment period subjects randomized to DFD-03 Lotion or Vehicle Lotion will use the study drug twice daily. Subjects randomized to Tazorac Cream or Vehicle Cream will use the study drug once daily in the evening. Read more about this study
- Who is it for?
- Ages 9 years and older
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- DFD-03 Lotion, 0.1% and Tazorac Cream, 0.1%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 155 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2017to 18 May 2018
- Phase
- Phase 2
- 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 9 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject must be at least 12 years of age. At selected site(s), a total of approximately eight subjects 9-11 years of age will be enrolled into the 2 arms of DFD-03 lotion group (active and vehicle).
- A clinical diagnosis of facial acne vulgaris with a facial Investigator's Global Assessment (IGA) score of 2 (mild) to 3 (moderate) at Baseline. At selected site(s), up to twelve subjects with acne lesions on the chest and/or back (including shoulders) in addition to those on the face will treat their chest and/or back (including shoulders) in addition to their face.
- Inflammatory lesion count (papules and pustules) of at least 20, non-inflammatory lesion count (closed and open comedones) of at least 25 on the face including the nose, and no more than 2 nodulocystic lesions. This criteria is not applicable to the 9-11 years age group as long as subjects have an IGA score of 2 (mild) to 3 (moderate) at Baseline.
- Females, regardless of childbearing potential: Must have a negative urine pregnancy test and if sexually active, must be on or use an acceptable method of birth control.
- Subjects agree not to use any product on the face during the entire course of study except for non-medicated, investigator-approved cleanser, sunscreen, face wash, and make-up as instructed by the investigator.
- Subjects must be willing to comply with sun avoidance measures for the face, including use of investigator-approved sunscreen and/or hats, have limited sun exposure time, and have no tanning bed use.
- Subject must be in good general health as determined by the investigator and supported by the medical history, physical examination and vital signs.
Who cannot join
- Females who are pregnant or lactating or planning to become pregnant during the study period.
- Treatment with the following products:
- Topical acne treatments or other topical facial medication in the 14 days prior to Baseline Systemic corticosteroids and systemic acne treatments in the 30 days prior to Baseline Systemic retinoid use in the 180 days prior to Baseline Undertaken certain facial procedures such as chemical peel, laser treatment, photodynamic therapy, acne surgery, cryodestruction or chemodestruction, x-ray therapy, intralesional steroids, dermabrasion, or depilation (except eyebrow shaping) in 30 days prior to Baseline.
- Treatment with a medication or procedure that, in the opinion of the investigator, would put the subject at unacceptable risk for participation in the study or may interfere with evaluations in the study.
- Treatment with an investigational product or device in 30 days prior to Baseline.
- Known allergic reaction to retinoids or tazarotene or any of the product ingredients.
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- Presence of any facial skin disease or condition that would interfere with the study or place the subject at unacceptable risk including sunburn, rosacea, seborrheic dermatitis, perioral dermatitis, lupus, dermatomyositis, psoriasis, eczema, squamous cell carcinoma, acneiform eruptions caused by medications, steroid acne, steroid folliculitis, bacterial folliculitis or any other facial disease or condition.
- Subjects with a serious and or chronic medical condition such as chronic or active liver disease, renal impairment, heart disease, severe respiratory disease, rheumatoid arthritis, current malignancies, immunocompromised conditions, or any other disease that, in the opinion of the investigator, would interfere with the study or place the subject at unacceptable risk.
- Subjects who have been treated for alcohol dependence or alcohol or drug abuse in the year.
Trial locations and contacts
1 site in 1 country.
United States1 site
International Dermatology Inc.
Miami, Florida, 33144
About this study
Official title: A Randomized, Double-Blind, Active-Controlled Study to Assess the Safety and Local Tolerability of DFD-03 (Tazarotene) Lotion, 0.1% Compared to Tazorac® (Tazarotene) Cream, 0.1% in the Topical Treatment of Acne Vulgaris for 12 Weeks
A study for Subjects with mild to moderate facial acne vulgaris. During the 12-week treatment period subjects randomized to DFD-03 Lotion or Vehicle Lotion will use the study drug twice daily. Subjects randomized to Tazorac Cream or Vehicle Cream will use the study drug once daily in the evening. Safety assessments will include the investigator's assessment of local cutaneous tolerance/application site reactions on the face, vital signs and adverse events.
Read the detailed description
A study for Subjects with mild to moderate facial acne vulgaris. Subjects will be randomized to treatment with either DFD-03 (tazarotene) Lotion 0.1%, Tazorac (tazarotene) Cream, 0.1%, Vehicle Lotion or Vehicle Cream. During the 12-week treatment period subjects randomized to DFD-03 Lotion or Vehicle Lotion will use the study drug twice daily. Subjects randomized to Tazorac Cream or Vehicle Cream will use the study drug once daily in the evening. Subjects will be instructed to treat the entire face.
Safety assessments will include the investigator's assessment of local cutaneous tolerance/application site reactions on the face, vital signs and adverse events. Urine pregnancy tests will be performed for all female subjects. A physical examination will be performed.
- Conditions
- Acne Vulgaris
- Being tested
- DFD-03 Lotion, 0.1%, Tazorac Cream, 0.1%, DFD-03 Vehicle Lotion 0%, Tazorac Vehicle Cream 0%
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DFD-03 Lotion, 0.1%Drug
Also called Tazarotene Lotion, 0.1%
DFD-03 Lotion will be applied to the face (avoiding areas around the eyes and mouth) twice daily, approximately 12 hours apart, and washed off after 1 minute.
Tazorac Cream, 0.1%Drug
Also called Tazarotene Cream, 0.1%
Tazorac Cream will be applied to the face (avoiding areas around the eyes and mouth) once daily in the evening and left on overnight.
DFD-03 Vehicle Lotion 0%Drug
Also called Vehicle Lotion 0%
Vehicle Lotion will be applied to the face (avoiding areas around the eyes and mouth) twice daily, approximately 12 hours apart, and washed off after 1 minute.
Tazorac Vehicle Cream 0%Drug
Also called Vehicle Cream 0%
Vehicle Cream will be applied to the face (avoiding areas around the eyes and mouth) once daily in the evening and left on overnight.
| Study group | Role | What they receive |
|---|---|---|
| DFD-03 Lotion, 0.1% | Experimental | DFD-03 Lotion, 0.1% to be applied twice daily approximately 12 hours apart, for 1 minute and rinsed off Receives: Drug: DFD-03 Lotion, 0.1% |
| Tazorac Cream, 0.1% | Active comparator | Tazorac Cream, 0.1% to be applied once in the evening and left overnight for approximately 12 hours Receives: Drug: Tazorac Cream, 0.1% |
| Vehicle Lotion | Placebo comparator | Vehicle Lotion to be applied twice daily for 1 minute and rinsed off Receives: Drug: DFD-03 Vehicle Lotion 0% |
| Vehicle Cream | Placebo comparator | Vehicle Cream to be applied once in the evening and left overnight for approximately 12 hours Receives: Drug: Tazorac Vehicle Cream 0% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event Occurences in DFD-03 Lotion Versus Tazorac Cream Groups
Frequency count of treatment emergent adverse events will be compared between DFD-03 Lotion and Tazorac Cream groups.
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2017
- Study start21 Aug 2017
- Primary completion18 May 2018
- Study completion18 May 2018
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Srinivas R. Sidgiddi, M.D., Study director, Dr. Reddy's Laboratories Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03341910
- Sponsor's protocol ID
- DFD-03-CD-008
- Status last verified
- Aug 2020
- First submitted
- 13 Oct 2017
- Last updated
- 17 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- 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 17 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Active-Controlled Study to Assess the Safety and Local Tolerability of DFD-03 (Tazarotene) Lotion, 0.1% Compared to Tazorac® (Tazarotene) Cream, 0.1% in the Topical Treatment of Acne Vulgaris for 12 Weeks
- ClinicalTrials.gov ID
- NCT03341910
- Acronym / sponsor ID
- DFD-03-CD-008
- Conditions
- Acne Vulgaris
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- 21 Aug 2017 (actual)
- Primary completion
- 18 May 2018 (actual)
- Study completion
- 18 May 2018 (actual)
- First posted
- 14 Nov 2017 (actual)
- Results
- Posted 17 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study for Subjects with mild to moderate facial acne vulgaris. During the 12-week treatment period subjects randomized to DFD-03 Lotion or Vehicle Lotion will use the study drug twice daily. Subjects randomized to Tazorac Cream or Vehicle Cream will use the study drug once daily in the evening. Safety assessments will include the investigator's assessment of local cutaneous tolerance/application site reactions on the face, vital signs and adverse events.
Detailed description
A study for Subjects with mild to moderate facial acne vulgaris. Subjects will be randomized to treatment with either DFD-03 (tazarotene) Lotion 0.1%, Tazorac (tazarotene) Cream, 0.1%, Vehicle Lotion or Vehicle Cream. During the 12-week treatment period subjects randomized to DFD-03 Lotion or Vehicle Lotion will use the study drug twice daily. Subjects randomized to Tazorac Cream or Vehicle Cream will use the study drug once daily in the evening. Subjects will be instructed to treat the entire face.
Safety assessments will include the investigator's assessment of local cutaneous tolerance/application site reactions on the face, vital signs and adverse events. Urine pregnancy tests will be performed for all female subjects. A physical examination will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| DFD-03 Lotion, 0.1% | Experimental | Drug: DFD-03 Lotion, 0.1%DFD-03 Lotion, 0.1% to be applied twice daily approximately 12 hours apart, for 1 minute and rinsed off |
| Tazorac Cream, 0.1% | Active comparator | Drug: Tazorac Cream, 0.1%Tazorac Cream, 0.1% to be applied once in the evening and left overnight for approximately 12 hours |
| Vehicle Lotion | Placebo comparator | Drug: DFD-03 Vehicle Lotion 0%Vehicle Lotion to be applied twice daily for 1 minute and rinsed off |
| Vehicle Cream | Placebo comparator | Drug: Tazorac Vehicle Cream 0%Vehicle Cream to be applied once in the evening and left overnight for approximately 12 hours |
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Subject must be at least 12 years of age. At selected site(s), a total of approximately eight subjects 9-11 years of age will be enrolled into the 2 arms of DFD-03 lotion group (active and vehicle).
- A clinical diagnosis of facial acne vulgaris with a facial Investigator's Global Assessment (IGA) score of 2 (mild) to 3 (moderate) at Baseline. At selected site(s), up to twelve subjects with acne lesions on the chest and/or back (including shoulders) in addition to those on the face will treat their chest and/or back (including shoulders) in addition to their face.
- Inflammatory lesion count (papules and pustules) of at least 20, non-inflammatory lesion count (closed and open comedones) of at least 25 on the face including the nose, and no more than 2 nodulocystic lesions. This criteria is not applicable to the 9-11 years age group as long as subjects have an IGA score of 2 (mild) to 3 (moderate) at Baseline.
- Females, regardless of childbearing potential: Must have a negative urine pregnancy test and if sexually active, must be on or use an acceptable method of birth control.
- Subjects agree not to use any product on the face during the entire course of study except for non-medicated, investigator-approved cleanser, sunscreen, face wash, and make-up as instructed by the investigator.
Key exclusion criteria (9 listed)
- Females who are pregnant or lactating or planning to become pregnant during the study period.
- Treatment with the following products:
- Topical acne treatments or other topical facial medication in the 14 days prior to Baseline Systemic corticosteroids and systemic acne treatments in the 30 days prior to Baseline Systemic retinoid use in the 180 days prior to Baseline Undertaken certain facial procedures such as chemical peel, laser treatment, photodynamic therapy, acne surgery, cryodestruction or chemodestruction, x-ray therapy, intralesional steroids, dermabrasion, or depilation (except eyebrow shaping) in 30 days prior to Baseline.
- Treatment with a medication or procedure that, in the opinion of the investigator, would put the subject at unacceptable risk for participation in the study or may interfere with evaluations in the study.
- Treatment with an investigational product or device in 30 days prior to Baseline.
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 |
|---|---|---|
| DFD-03 Lotion, 0.1%Also: Tazarotene Lotion, 0.1%DFD-03 Lotion will be applied to the face (avoiding areas around the eyes and mouth) twice daily, approximately 12 hours apart, and washed off after 1 minute. | Drug | DFD-03 Lotion, 0.1% |
| Tazorac Cream, 0.1%Also: Tazarotene Cream, 0.1%Tazorac Cream will be applied to the face (avoiding areas around the eyes and mouth) once daily in the evening and left on overnight. | Drug | Tazorac Cream, 0.1% |
| DFD-03 Vehicle Lotion 0%Also: Vehicle Lotion 0%Vehicle Lotion will be applied to the face (avoiding areas around the eyes and mouth) twice daily, approximately 12 hours apart, and washed off after 1 minute. | Drug | Vehicle Lotion |
| Tazorac Vehicle Cream 0%Also: Vehicle Cream 0%Vehicle Cream will be applied to the face (avoiding areas around the eyes and mouth) once daily in the evening and left on overnight. | Drug | Vehicle Cream |
Primary outcome
Adverse Event Occurences in DFD-03 Lotion Versus Tazorac Cream Groups
Time frame: Baseline to Week 12
Frequency count of treatment emergent adverse events will be compared between DFD-03 Lotion and Tazorac Cream groups.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2020.
- 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.
Srinivas R. Sidgiddi, M.D. study director
Dr. Reddy's Laboratories Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DFD-03 Lotion, 0.1% and Tazorac Cream, 0.1% in people with Acne Vulgaris, run by Dr. Reddy's Laboratories Limited 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 7 inclusion and 9 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 17 Aug 2020. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 17 Aug 2020). 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?
Adverse Event Occurences in DFD-03 Lotion Versus Tazorac Cream Groups (time frame: Baseline to 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 17 Aug 2020.