Acne VulgarisPhase 2NCT03599193
A Bioavailability Study of DFD-03 Compared to Tazorac® in Patients With Moderate Acne Vulgaris
A Phase 2 study testing Tazarotene Lotion, 0.1% and Tazarotene Cream, 0.1% in people with Acne Vulgaris, run by Dr. Reddy's Laboratories Limited at 2 sites in United States.
Trial summary
This was a multicenter, randomized, multiple-dose, laboratory-blinded, open-label, 2-arm, parallel-arm study in subjects with moderate acne vulgaris. 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?
- Tazarotene Lotion, 0.1% and Tazarotene Cream, 0.1%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Oct 2017to 30 Apr 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 understands the study procedures, is willing to comply with the study procedures and required visits, and agrees to participate by giving written informed consent. Subjects under the legal age of consent must provide written assent and must have the written informed consent of their legal guardian.
- Subject (or legal guardian) must be willing to authorize use and disclosure of protected health information collected for the study.
- Male or female at least 9 years of age for the DFD-03 (Test) group and at least 12 years of age for the Tazorac Cream (Reference) group.
- Female subjects must be having their menstrual period at Baseline (Day 1, 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 acne vulgaris with a facial Investigator's Global Assessment (IGA) score of 3 (moderate) at Baseline (Day 1).
- Subjects should have acne lesions on at least 1 of the following regions at the Screening visit: neck, upper chest, upper back (including shoulders).
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- This criterion is not applicable to the 9-11 years and 11 months age group.
- Inflammatory lesion count (papules and pustules) of at least 20 on the face, including the nose, at Baseline (Day 1).
- This criterion is not applicable to the 9-11 years and 11 months age group.
- Non-inflammatory lesion count (closed and open comedones) of at least 25 on the face, including the nose, at Baseline (Day 1).
- This criterion is not applicable to the 9-11 years and 11 months age group.
- No more than 2 nodulocystic lesions on the face, including the nose, at Baseline (Day 1).
- Females, regardless of childbearing potential:
- Must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline (Day 1). Urine pregnancy test must have a sensitivity of at least 25 mIU/mL for βhCG.
- If sexually active, must be on or use an acceptable method of birth control. Acceptable methods of birth control include hormonal methods* or intrauterine device in use ≥ 90 days prior to Baseline (Day 1); or partner has had a vasectomy at least 90 days prior to Baseline (Day 1); or barrier methods plus spermicide; or Essure® that has been in place for at least 3 months before the screening visit with radiograph confirmation of fallopian tube blockage.
- Hormonal methods: If on hormonal contraceptives, must have been on the same hormonal contraceptive product for 3 months (90 days) prior to Baseline (Day 1) and continued on same method and dose throughout the duration of the study. If subject had used hormonal birth control and had stopped, this should have occurred more than 6 months prior to Baseline.
- Exception: Sexually inactive female subjects are not required to practice a reliable method of contraception and may be enrolled at the investigator's discretion if they are counseled to remain sexually inactive for the duration of the study and understand the possible risks involved in getting pregnant during the study. An abstinent female must agree that if she becomes sexually active during the study she will use an acceptable form of contraception such as a barrier method with spermicide.
- 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. Subjects should continue to use these investigator-approved products for the duration of the study and should avoid any changes in these consumer products.
- 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 direct sunlight exposure time, and have no tanning bed use or use of other UV light sources during participation in the study.
- 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 (other retinoids, antibiotics, benzoyl peroxide, azelaic acid, resorcinol, salicylates, α-hydroxy/glycolic acid), or other topical facial medication (antifungals, steroids, anti-inflammatories) on the treatment area in the 14 days prior to Baseline (Day 1), including prescription and non-prescription products.
- Systemic corticosteroids, systemic acne treatments including systemic antibiotics used for treatment of acne, potential photosensitizing agents (thiazides, phenothiazines), spironolactone, flutamide, or immunosuppressant drugs in the 30 days prior to Baseline (Day 1).
- Systemic retinoid use (including high-dose vitamin A > 10,000 units per day) in the 180 days prior to Baseline (Day 1).
- 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 Baseline (Day 1). 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 Baseline (Day 1).
- Known allergic reaction to retinoids or tazarotene or any of the other ingredients of these products. The inactive ingredients are sodium lauryl sulphate, stearyl alcohol, cetyl alcohol, gluconolactone, Vitamin E polyethylene glycol succinate, glycerin, carbomer P 971, propylparaben, methylparaben, edetate disodium, butylated hydroxytoluene, medium-chain triglyceride, trolamine, and purified water.
- 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.
- Excessive facial hair (i.e., heavy beard or mustache), facial tattoos, or facial disfigurement, excessive hair on the neck, upper chest, shoulders and upper back region that would interfere with study assessments.
- 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 prior to Baseline (Day 1).
- Subjects who have been in another investigational trial within 30 days of Baseline (Day 1).
- Subjects may not have a personal relationship with any member of the study staff or be part of the staff at the medical practice.
- HIV Ag/Ab Combo, Hepatitis B (HBsAg (B)) and Hepatitis C (anti-HCV (C)) positive subjects.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dr. DuBois
Austin, Texas, 73301
Dr. Jones
Austin, Texas, 73301
About this study
Official title: A Randomized, Open-Label, Multiple Dose, Bioavailability Study of DFD-03 (Tazarotene Lotion, 0.1 % ) Dosed Twice Daily Compared to Once Daily Tazorac® (Tazarotene) Cream, 0.1% in Patients With Moderate Acne Vulgaris
This was a multicenter, randomized, multiple-dose, laboratory-blinded, open-label, 2-arm, parallel-arm study in subjects with moderate acne vulgaris.
Read the detailed description
This was a multicenter, randomized, multiple-dose, laboratory-blinded, open-label, 2-arm, parallel-arm study in subjects with moderate acne vulgaris.
Approximately 62 subjects were randomized, stratified by age (Adult subjects: 17 years or older; Pediatric subjects: 9 years to 16 years 11 months for the Test product and 12 years to 16 years 11 months for the Reference product). The study was conducted in two parts, Part A and Part B in a sequential manner. Based on full PK profiles generated for adult subjects in Part A, the sparse PK sampling design in pediatric population was established in Part B.
- Conditions
- Acne Vulgaris
- Being tested
- Tazarotene Lotion, 0.1%, Tazarotene Cream, 0.1%
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tazarotene Lotion, 0.1%Drug
Also called DFD-03 Lotion
DFD-03 (Tazarotene Lotion, 0.1%) applied Twice Daily for 1 minute and rinsed off
Tazarotene Cream, 0.1%Drug
Also called Tazorac Cream
Tazorac® (tazarotene) Cream, 0.1% applied Once Daily and left for approximately 12 hours
| Study group | Role | What they receive |
|---|---|---|
| DFD-03 Lotion | Experimental | DFD-03 Lotion will be applied to the affected areas twice daily for 1 minute and rinsed off. 29 subjects will be enrolled into this arm. Receives: Drug: Tazarotene Lotion, 0.1% |
| Tazorac Cream | Active comparator | Tazorac Cream will be applied to the affected areas once daily and left on for ~12 hours. 29 subjects will be enrolled into this arm. Receives: Drug: Tazarotene Cream, 0.1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax)
The maximum plasma concentration of tazarotenic acid post dosing on Day 21 (Cmax(ss))
Measured: Day 21
Area Under the Curve (AUC0-24) at Steady State
The Area Under the Curve time 0 to 24 hours (AUC0-24ss) of tazarotenic acid at steady state (Day 21)
Measured: Day 21
Number of Subjects With Treatment Emergent Adverse Events (TEAE)
Number of subjects with at least one TEAE from the time of signing the consent until the end of the study (Approximately 21 days).
Measured: Day 1 to Day 21
Secondary outcomes (1)
Time to Maximum Concentration (Tmax) of Tazarotenic Acid
Time to maximum concentration (Tmax(ss)) of tazarotenic acid at steady state (Day 21)
Measured: Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start4 Oct 2017
- Primary completion30 Apr 2018
- Study completion30 Apr 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anirudh Gautam, Study director, Dr. Reddy's Laboratories Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03599193
- Sponsor's protocol ID
- DFD-03-CD-007
- Status last verified
- Feb 2021
- First submitted
- 29 Jun 2018
- Last updated
- 1 Mar 2021
- 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 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Multiple Dose, Bioavailability Study of DFD-03 (Tazarotene Lotion, 0.1 % ) Dosed Twice Daily Compared to Once Daily Tazorac® (Tazarotene) Cream, 0.1% in Patients With Moderate Acne Vulgaris
- ClinicalTrials.gov ID
- NCT03599193
- Acronym / sponsor ID
- DFD-03-CD-007
- Conditions
- Acne Vulgaris
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- 4 Oct 2017 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Posted 14 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a multicenter, randomized, multiple-dose, laboratory-blinded, open-label, 2-arm, parallel-arm study in subjects with moderate acne vulgaris.
Detailed description
This was a multicenter, randomized, multiple-dose, laboratory-blinded, open-label, 2-arm, parallel-arm study in subjects with moderate acne vulgaris.
Approximately 62 subjects were randomized, stratified by age (Adult subjects: 17 years or older; Pediatric subjects: 9 years to 16 years 11 months for the Test product and 12 years to 16 years 11 months for the Reference product). The study was conducted in two parts, Part A and Part B in a sequential manner. Based on full PK profiles generated for adult subjects in Part A, the sparse PK sampling design in pediatric population was established in Part B.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DFD-03 Lotion | Experimental | Drug: Tazarotene Lotion, 0.1%DFD-03 Lotion will be applied to the affected areas twice daily for 1 minute and rinsed off. 29 subjects will be enrolled into this arm. |
| Tazorac Cream | Active comparator | Drug: Tazarotene Cream, 0.1%Tazorac Cream will be applied to the affected areas once daily and left on for ~12 hours. 29 subjects will be enrolled into this arm. |
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (20 listed)
- Subject understands the study procedures, is willing to comply with the study procedures and required visits, and agrees to participate by giving written informed consent. Subjects under the legal age of consent must provide written assent and must have the written informed consent of their legal guardian.
- Subject (or legal guardian) must be willing to authorize use and disclosure of protected health information collected for the study.
- Male or female at least 9 years of age for the DFD-03 (Test) group and at least 12 years of age for the Tazorac Cream (Reference) group.
- Female subjects must be having their menstrual period at Baseline (Day 1, 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 acne vulgaris with a facial Investigator's Global Assessment (IGA) score of 3 (moderate) at Baseline (Day 1).
Key exclusion criteria (16 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. The inactive ingredients are sodium lauryl sulphate, stearyl alcohol, cetyl alcohol, gluconolactone, Vitamin E polyethylene glycol succinate, glycerin, carbomer P 971, propylparaben, methylparaben, edetate disodium, butylated hydroxytoluene, medium-chain triglyceride, trolamine, and purified water.
- 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.
- Excessive facial hair (i.e., heavy beard or mustache), facial tattoos, or facial disfigurement, excessive hair on the neck, upper chest, shoulders and upper back region that would interfere with study assessments.
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 |
|---|---|---|
| Tazarotene Lotion, 0.1%Also: DFD-03 LotionDFD-03 (Tazarotene Lotion, 0.1%) applied Twice Daily for 1 minute and rinsed off | Drug | DFD-03 Lotion |
| Tazarotene Cream, 0.1%Also: Tazorac CreamTazorac® (tazarotene) Cream, 0.1% applied Once Daily and left for approximately 12 hours | Drug | Tazorac Cream |
Primary outcome
Maximum Plasma Concentration (Cmax)
Time frame: Day 21
The maximum plasma concentration of tazarotenic acid post dosing on Day 21 (Cmax(ss))
Area Under the Curve (AUC0-24) at Steady State
Time frame: Day 21
The Area Under the Curve time 0 to 24 hours (AUC0-24ss) of tazarotenic acid at steady state (Day 21)
Number of Subjects With Treatment Emergent Adverse Events (TEAE)
Time frame: Day 1 to Day 21
Number of subjects with at least one TEAE from the time of signing the consent until the end of the study (Approximately 21 days).
1 secondary outcome
Time to Maximum Concentration (Tmax) of Tazarotenic Acid
Time frame: Day 21
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.
- 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.
Anirudh Gautam study director
Dr. Reddy's Laboratories Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tazarotene Lotion, 0.1% and Tazarotene Cream, 0.1% in people with Acne Vulgaris, run by Dr. Reddy's Laboratories Limited at 2 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 20 inclusion and 16 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 2 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. 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 14 Sep 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?
Maximum Plasma Concentration (Cmax) (time frame: Day 21). 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.