Acne VulgarisPhase 3NCT03292640
A Study of the Safety and Efficacy of DFD-03 Lotion in the Treatment of Acne Vulgaris for 12 Weeks
A Phase 3 study testing DFD-03 (0.1% tazarotene) Lotion in people with Acne Vulgaris, run by Dr. Reddy's Laboratories Limited at 1 site in United States.
Trial summary
Enrollment of subjects with mild to moderate facial acne vulgaris. Co-Primary efficacy endpoints included: Absolute change from Baseline to Week 12 in the inflammatory lesion counts on the face Absolute change from Baseline to Week 12 in the non-inflammatory lesion counts on the face Proportion of subjects with a… 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 (0.1% tazarotene) Lotion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 547 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jul 2017to 14 May 2018
- 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 9 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject must be at least 9 years of age.
- Female subjects must be having their period at the Baseline Visit (as reported by the subject), except for subjects using hormonal contraceptives that preclude menstrual periods, if the subject is premenarcheal, is postmenopausal for at least 12 months prior to baseline, is surgically sterilized (i.e. tubal ligation) or if the subject is without a uterus and /or both ovaries.
- A clinical diagnosis of facial mild to moderate acne vulgaris. Subjects with acne lesions on the chest and/or back (including shoulders) in addition to those on the face have the option of treating their back and/or chest (including shoulders) in addition to their face.
- Inflammatory lesion count (papules and pustules) of at least 20 on the face, and 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 on the face, including the nose.
- 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 must be willing to comply with sun avoidance measures for the face (as well as back/chest and shoulders, if applicable) 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 normal or not clinically significant abnormal vital signs (blood pressure and pulse).
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 on the treatment area in the 14 days prior to the Baseline Visit, including prescription and non-prescription products.
- Systemic corticosteroids, systemic acne treatments including systemic antibiotics used for treatment of acne, potential photosensitizing agents spironolactone, flutamide, or immunosuppressant drugs in the 30 days prior to the Baseline Visit.
- Systemic retinoid use in the 180 days prior to the Baseline Visit.
- 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 the 30 days prior to the Baseline Visit. After the subject is enrolled in the study, eyebrow shaping (except for tweezing) is prohibited.
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- 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 the 30 days prior to the Baseline Visit.
- Known allergic reaction to retinoids or tazarotene or any of the other ingredients of these products.
- 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.
- 7. Subjects who have been treated for alcohol dependence or alcohol or drug abuse in the year.
- 8. Subjects who have been in another investigational trial within 30 days.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Dermatology Clinical Research Inc.
Fremont, California, 94538
About this study
Official title: A Multicenter, Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled Study of the Safety and Efficacy of DFD-03 Lotion in the Treatment of Acne Vulgaris for 12 Weeks
Enrollment of subjects with mild to moderate facial acne vulgaris.
Co-Primary efficacy endpoints included:
- Absolute change from Baseline to Week 12 in the inflammatory lesion counts on the face
- Absolute change from Baseline to Week 12 in the non-inflammatory lesion counts on the face
- Proportion of subjects with a clinical response of "success" at Week 12 for lesions on the face. Success based on IGA is defined as an IGA score of 0 (Clear) or 1 (Almost clear) at Week 12 with at least a 2-grade reduction from Baseline.
Read the detailed description
Enrollment of subjects with mild to moderate facial acne vulgaris. Acne lesions of any severity on the chest and/or back (including shoulders) were enrolled provided they had mild to moderate acne on the face. During the 12-week treatment period subjects used the study product twice daily with approximately 12 hours between applications. Subjects were instructed to treat the entire face (and chest/back including shoulders, if applicable).
Co-Primary efficacy endpoints included:
- Absolute change from Baseline to Week 12 in the inflammatory lesion counts on the face
- Absolute change from Baseline to Week 12 in the non-inflammatory lesion counts on the face
- Proportion of subjects with a clinical response of "success" at Week 12 for lesions on the face. Success based on IGA is defined as an IGA score of 0 (Clear) or 1 (Almost clear) at Week 12 with at least a 2-grade reduction from Baseline.
The primary safety endpoint was treatment-emergent adverse events (TEAEs). Other safety variables included local cutaneous tolerance evaluation (dryness, non-lesional erythema, peeling, stinging, burning, and itching) and vital signs (blood pressure and pulse rate). Urine pregnancy tests were performed at Baseline and at every visit through Week 12 for all female subjects. A physical examination was performed at the Baseline Visit.
- Conditions
- Acne Vulgaris
- Being tested
- DFD-03 (0.1% tazarotene) Lotion, DFD-03 (0% tazarotene) Lotion (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.
DFD-03 (0.1% tazarotene) LotionDrug
Also called DFD-03
DFD-03 Lotion (0.1% tazarotene) - twice daily application
DFD-03 (0% tazarotene) Lotion (Placebo)Drug
Also called Placebo
DFD-03 Vehicle Lotion (0% tazarotene) - twice daily application
| Study group | Role | What they receive |
|---|---|---|
| DFD-03 Lotion (0.1% tazarotene) | Experimental | DFD-03 Lotion (0.1% tazarotene) Receives: Drug: DFD-03 (0.1% tazarotene) Lotion |
| DFD-03 Vehicle (0% tazarotene) | Placebo comparator | DFD-03 Vehicle Lotion (0% tazarotene) Receives: Drug: DFD-03 (0% tazarotene) Lotion (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute Change in the Inflammatory Lesion Counts on the Face
Change in inflammatory lesion counts on the face from baseline to Week 12
Measured: Baseline to Week 12
Proportion of Subjects With a Clinical Response of "Success" at Week 12 for Lesions on the Face Based on IGA.
IGA success at Week 12 (an IGA score of 0 (Clear) or 1 (almost clear) with at least a 2-grade reduction from baseline)
Measured: Baseline to Week 12
Absolute Change in the Non-inflammatory Lesion Counts on the Face
Change in non-inflammatory lesion counts on the face from baseline to Week 12 - will be analyzed using the ANCOVA model
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 posted25 Sep 2017
- Study start6 Jul 2017
- Primary completion14 May 2018
- Study completion14 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 547 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03292640
- Sponsor's protocol ID
- DFD-03-CD-006
- Status last verified
- Feb 2021
- First submitted
- 21 Sep 2017
- Last updated
- 1 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled Study of the Safety and Efficacy of DFD-03 Lotion in the Treatment of Acne Vulgaris for 12 Weeks
- ClinicalTrials.gov ID
- NCT03292640
- Acronym / sponsor ID
- DFD-03-CD-006
- Conditions
- Acne Vulgaris
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 547 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- 6 Jul 2017 (actual)
- Primary completion
- 14 May 2018 (actual)
- Study completion
- 14 May 2018 (actual)
- First posted
- 25 Sep 2017 (actual)
- Results
- Posted 9 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Enrollment of subjects with mild to moderate facial acne vulgaris.
Co-Primary efficacy endpoints included:
- Absolute change from Baseline to Week 12 in the inflammatory lesion counts on the face
- Absolute change from Baseline to Week 12 in the non-inflammatory lesion counts on the face
- Proportion of subjects with a clinical response of "success" at Week 12 for lesions on the face. Success based on IGA is defined as an IGA score of 0 (Clear) or 1 (Almost clear) at Week 12 with at least a 2-grade reduction from Baseline.
Detailed description
Enrollment of subjects with mild to moderate facial acne vulgaris. Acne lesions of any severity on the chest and/or back (including shoulders) were enrolled provided they had mild to moderate acne on the face. During the 12-week treatment period subjects used the study product twice daily with approximately 12 hours between applications. Subjects were instructed to treat the entire face (and chest/back including shoulders, if applicable).
Co-Primary efficacy endpoints included:
- Absolute change from Baseline to Week 12 in the inflammatory lesion counts on the face
- Absolute change from Baseline to Week 12 in the non-inflammatory lesion counts on the face
- Proportion of subjects with a clinical response of "success" at Week 12 for lesions on the face. Success based on IGA is defined as an IGA score of 0 (Clear) or 1 (Almost clear) at Week 12 with at least a 2-grade reduction from Baseline.
The primary safety endpoint was treatment-emergent adverse events (TEAEs). Other safety variables included local cutaneous tolerance evaluation (dryness, non-lesional erythema, peeling, stinging, burning, and itching) and vital signs (blood pressure and pulse rate). Urine pregnancy tests were performed at Baseline and at every visit through Week 12 for all female subjects. A physical examination was performed at the Baseline Visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DFD-03 Lotion (0.1% tazarotene) | Experimental | Drug: DFD-03 (0.1% tazarotene) LotionDFD-03 Lotion (0.1% tazarotene) |
| DFD-03 Vehicle (0% tazarotene) | Placebo comparator | Drug: DFD-03 (0% tazarotene) Lotion (Placebo)DFD-03 Vehicle Lotion (0% tazarotene) |
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Subject must be at least 9 years of age.
- Female subjects must be having their period at the Baseline Visit (as reported by the subject), except for subjects using hormonal contraceptives that preclude menstrual periods, if the subject is premenarcheal, is postmenopausal for at least 12 months prior to baseline, is surgically sterilized (i.e. tubal ligation) or if the subject is without a uterus and /or both ovaries.
- A clinical diagnosis of facial mild to moderate acne vulgaris. Subjects with acne lesions on the chest and/or back (including shoulders) in addition to those on the face have the option of treating their back and/or chest (including shoulders) in addition to their face.
- Inflammatory lesion count (papules and pustules) of at least 20 on the face, and 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 on the face, including the nose.
- Females, regardless of childbearing potential:
Key exclusion criteria (13 listed)
- Females who are pregnant or lactating or planning to become pregnant during the study period.
- Treatment with the following products:
- Known allergic reaction to retinoids or tazarotene or any of the other ingredients of these products.
- 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.
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 (0.1% tazarotene) LotionAlso: DFD-03DFD-03 Lotion (0.1% tazarotene) - twice daily application | Drug | DFD-03 Lotion (0.1% tazarotene) |
| DFD-03 (0% tazarotene) Lotion (Placebo)Also: PlaceboDFD-03 Vehicle Lotion (0% tazarotene) - twice daily application | Drug | DFD-03 Vehicle (0% tazarotene) |
Primary outcome
Absolute Change in the Inflammatory Lesion Counts on the Face
Time frame: Baseline to Week 12
Change in inflammatory lesion counts on the face from baseline to Week 12
Proportion of Subjects With a Clinical Response of "Success" at Week 12 for Lesions on the Face Based on IGA.
Time frame: Baseline to Week 12
IGA success at Week 12 (an IGA score of 0 (Clear) or 1 (almost clear) with at least a 2-grade reduction from baseline)
Absolute Change in the Non-inflammatory Lesion Counts on the Face
Time frame: Baseline to Week 12
Change in non-inflammatory lesion counts on the face from baseline to Week 12 - will be analyzed using the ANCOVA model
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2021.
- 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.
Srinivas R. Sidgiddi, M.D. study director
Dr. Reddy's Laboratories
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DFD-03 (0.1% tazarotene) Lotion 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 8 inclusion and 13 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 1 Mar 2021. 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 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 9 Jun 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?
Absolute Change in the Inflammatory Lesion Counts on the Face (time frame: Baseline to Week 12). The study lists 3 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 1 Mar 2021.