AcnePhase 3NCT02249767
Bioequivalence Study of Tretinoin Gel 0.05% to Brand Tretinoin Gel
A Phase 3 study testing Tretinoin in people with Acne, run by Spear Pharmaceuticals.
Trial summary
This was a double-blind, randomized, three-treatment, parallel study. Normal, healthy male and female children and adults (i.e., ages 12 to 40 years) with at least Grade 2 (i.e., mild severity) acne vulgaris were treated on the full face once daily for 84 days with the Tretinoin Gel 0.05%, Brand (tretinoin) Gel 0.05%… Read more about this study
- Who is it for?
- Ages 12 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne
- What is being tested?
- Tretinoin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 574 participants
- Where
- No sites listed yet
- Study dates
- Nov 2013to Jun 2014
- 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
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Normal, healthy male and female children and adults aged 12 to 40 years
- Written and verbal informed consent had to be obtained. Subjects aged 12 to 17 years, had to sign an assent for the study and a parent or a legal guardian had to sign the informed consent
- Women of childbearing potential had to be non-pregnant and non-nursing, and had to be willing to avoid pregnancy during the course of the study and during the menstrual cycle following completion of their participation in the study. Adequate contraception was defined as systemic birth control, such as oral contraceptives, for three months prior and implantable/injectable contraceptives (e.g., Norplant, intrauterine device [IUD]) for six months prior to study drug administration; or barrier methods, such as diaphragm plus spermicide or condom plus spermicide, consistently for at least 14 days prior to study drug administration; or abstinence.
- On the face, having ≥ 20 inflammatory (i.e., papules and pustules) and ≥ 25 non-inflammatory (i.e., open and closed comedones) lesions with ≤ 2 nodulocystic lesions (i.e, nodules and cysts), as per FDA Draft Guidance on Tretinoin, dated March 20
- Able to refrain from the use of all other topical acne medications or antibiotics during the treatment period
- Considered reliable and capable of understanding their responsibility and role in the study
Who cannot join
- 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, acneform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis). Note: Eczema and psoriasis on the body are not exclusions.
- Subjects with active cystic acne as evidenced by more than 2 facial nodules. Nodules are defined as in 7.3.3 as: deep-seated in the skin (i.e., centered in the dermis or subcutis) and greater than 5 mm in diameter.
- More than 40 papules and/or pustules (inflammatory lesions).
- More than 60 open and/or closed comedones/milia (non-inflammatory lesions).
- Overall severity grade of less than 2 or greater than 4.
- History of allergy or hypersensitivity to tretinoin, retinoids, or any of the study medication ingredients.
Show all 15Show fewer
- Significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hepatic, neurological, pancreatic, or renal disease.
- Use within 6 months prior to baseline of systemic retinoid (isotretinoin) treatment or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed).
- Oral contraceptives started or changed within 3 months prior to study initiation or planned to change during the study.
- Use on the face within 1 month prior to baseline of 1) cryodestruction or chemodestruction, 2) dermabrasion, 3) photodynamic therapy, 4) acne surgery, 5) intralesional steroids, or 6) x-ray therapy.
- Use within 1 month prior to baseline of 1) spironolactone, 2) systemic steroids, 3) systemic antibiotics, 4) systemic treatment for acne vulgaris (other than oral retinoids, which require a 6-month washout), or 5) systemic anti-inflammatory agents.
- Use within 2 weeks prior to baseline of 1) topical steroids, 2) topical retinoids, 3) topical acne treatments including over-the-counter preparations, 4) topical anti-inflammatory agents, or 5) topical antibiotics.
- Pregnant or breast-feeding.
- Serious psychological illness.
- Significant history (within the past year) of alcohol or drug abuse.
About this study
This was a double-blind, randomized, three-treatment, parallel study. Normal, healthy male and female children and adults (i.e., ages 12 to 40 years) with at least Grade 2 (i.e., mild severity) acne vulgaris were treated on the full face once daily for 84 days with the Tretinoin Gel 0.05%, Brand (tretinoin) Gel 0.05%, or Gel Vehicle. Acne lesions were graded by a single blinded observer at screening and at Weeks 0 (i.e., baseline), 2, 4, 8, and 12 at each location.
Read the detailed description
This was a double-blind, randomized, three-treatment, parallel study conducted at three locations with a single investigator. Normal, healthy male and female children and adults (i.e., ages 12 to 40 years) with at least Grade 2 (i.e., mild severity) acne vulgaris were treated on the full face once daily for 84 days with the Tretinoin Gel 0.05%, Brand (tretinoin) Gel 0.05%, or Gel Vehicle. Acne lesions were graded by a single blinded observer at screening and at Weeks 0 (i.e., baseline), 2, 4, 8, and 12 at each location.
The assigned study treatment was self-applied topically once daily for 84 consecutive days. Scheduled study visits included:
- Visit 1 (Baseline Visit, Day 0)
- Visit 2 (First Interim Visit, Day 14)
- Visit 3 (Second Interim Visit, Day 28)
- Visit 4 (Third Interim Visit, Day 56)
- Visit 5 (Forth Interim Visit, Day 84)
A window of ± 4 days was considered acceptable for each scheduled visit following the Baseline Visit. Subjects were admitted into the study if they had a clinical diagnosis of acne vulgaris and if they met the inclusion/exclusion criteria. During the study visits, the following procedures were performed:
- Counts of inflammatory, non-inflammatory, and nodulocystic lesions
- The Investigator's Global Assessment (IGA)
- Assessment of application site reactions Safety was assessed by the monitoring of AEs and documenting signs and/or symptoms of application site reactions.
- Conditions
- Acne
- Being tested
- Tretinoin
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TretinoinDrug
Also called Placebo
Treatment of acne once daily in evening
| Study group | Role | What they receive |
|---|---|---|
| Generic Tretinoin | Active comparator | Treatment of acne once daily over 12 weeks Receives: Drug: Tretinoin |
| Brand Tretinoin | Active comparator | Treatment of Acne once daily over 12 weeks Receives: Drug: Tretinoin |
| Placebo Vehicle | Placebo comparator | Treatment of acne once daily over 12 weeks Receives: Drug: Tretinoin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Baseline Acne Lesions at Week 12
Percent change in baseline in inflammatory and non-inflammatory lesions at week 12.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2014 (estimated)
- Study startNov 2013
- Primary completionJun 2014
- Study completionJun 2014
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 AcneStudies 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
- 574 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spear Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Susan Barker, MD, Principal investigator, Moore Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02249767
- Sponsor's protocol ID
- Tret.2014.10.01.14
- Status last verified
- Jan 2020
- First submitted
- 23 Sep 2014
- Last updated
- 10 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Study of Tretinoin Gel 0.05% to Brand Tretinoin Gel
- ClinicalTrials.gov ID
- NCT02249767
- Acronym / sponsor ID
- Tret.2014.10.01.14
- Conditions
- Acne
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 574 participants (actual)
- Lead sponsor
- Spear PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 26 Sep 2014 (estimated)
- Results
- Posted 13 Jan 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 double-blind, randomized, three-treatment, parallel study. Normal, healthy male and female children and adults (i.e., ages 12 to 40 years) with at least Grade 2 (i.e., mild severity) acne vulgaris were treated on the full face once daily for 84 days with the Tretinoin Gel 0.05%, Brand (tretinoin) Gel 0.05%, or Gel Vehicle. Acne lesions were graded by a single blinded observer at screening and at Weeks 0 (i.e., baseline), 2, 4, 8, and 12 at each location.
Detailed description
This was a double-blind, randomized, three-treatment, parallel study conducted at three locations with a single investigator. Normal, healthy male and female children and adults (i.e., ages 12 to 40 years) with at least Grade 2 (i.e., mild severity) acne vulgaris were treated on the full face once daily for 84 days with the Tretinoin Gel 0.05%, Brand (tretinoin) Gel 0.05%, or Gel Vehicle. Acne lesions were graded by a single blinded observer at screening and at Weeks 0 (i.e., baseline), 2, 4, 8, and 12 at each location.
The assigned study treatment was self-applied topically once daily for 84 consecutive days. Scheduled study visits included:
- Visit 1 (Baseline Visit, Day 0)
- Visit 2 (First Interim Visit, Day 14)
- Visit 3 (Second Interim Visit, Day 28)
- Visit 4 (Third Interim Visit, Day 56)
- Visit 5 (Forth Interim Visit, Day 84)
A window of ± 4 days was considered acceptable for each scheduled visit following the Baseline Visit. Subjects were admitted into the study if they had a clinical diagnosis of acne vulgaris and if they met the inclusion/exclusion criteria. During the study visits, the following procedures were performed:
- Counts of inflammatory, non-inflammatory, and nodulocystic lesions
- The Investigator's Global Assessment (IGA)
- Assessment of application site reactions Safety was assessed by the monitoring of AEs and documenting signs and/or symptoms of application site reactions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Generic Tretinoin | Active comparator | Drug: TretinoinTreatment of acne once daily over 12 weeks |
| Brand Tretinoin | Active comparator | Drug: TretinoinTreatment of Acne once daily over 12 weeks |
| Placebo Vehicle | Placebo comparator | Drug: TretinoinTreatment of acne once daily over 12 weeks |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Normal, healthy male and female children and adults aged 12 to 40 years
- Written and verbal informed consent had to be obtained. Subjects aged 12 to 17 years, had to sign an assent for the study and a parent or a legal guardian had to sign the informed consent
- Women of childbearing potential had to be non-pregnant and non-nursing, and had to be willing to avoid pregnancy during the course of the study and during the menstrual cycle following completion of their participation in the study. Adequate contraception was defined as systemic birth control, such as oral contraceptives, for three months prior and implantable/injectable contraceptives (e.g., Norplant, intrauterine device [IUD]) for six months prior to study drug administration; or barrier methods, such as diaphragm plus spermicide or condom plus spermicide, consistently for at least 14 days prior to study drug administration; or abstinence.
- On the face, having ≥ 20 inflammatory (i.e., papules and pustules) and ≥ 25 non-inflammatory (i.e., open and closed comedones) lesions with ≤ 2 nodulocystic lesions (i.e, nodules and cysts), as per FDA Draft Guidance on Tretinoin, dated March 20
- Able to refrain from the use of all other topical acne medications or antibiotics during the treatment period
Key exclusion criteria (15 listed)
- 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, acneform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis). Note: Eczema and psoriasis on the body are not exclusions.
- Subjects with active cystic acne as evidenced by more than 2 facial nodules. Nodules are defined as in 7.3.3 as: deep-seated in the skin (i.e., centered in the dermis or subcutis) and greater than 5 mm in diameter.
- More than 40 papules and/or pustules (inflammatory lesions).
- More than 60 open and/or closed comedones/milia (non-inflammatory lesions).
- Overall severity grade of less than 2 or greater than 4.
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 |
|---|---|---|
| TretinoinAlso: PlaceboTreatment of acne once daily in evening | Drug | Brand Tretinoin, Generic Tretinoin, Placebo Vehicle |
Primary outcome
Percent Change in Baseline Acne Lesions at Week 12
Time frame: Baseline and 12 weeks
Percent change in baseline in inflammatory and non-inflammatory lesions at week 12.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2020.
- 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.
Susan Barker, MD principal investigator
Moore Clinical Research
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tretinoin in people with Acne, run by Spear Pharmaceuticals.
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 15 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 10 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
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 13 Jan 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?
Percent Change in Baseline Acne Lesions at Week 12 (time frame: Baseline and 12 weeks). 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 10 Feb 2020.