AcnePhase 4NCT02457520
ABSORICA in Patients With Severe Recalcitrant Nodular Acne
A Phase 4 study testing Isotretinoin in people with Acne, run by Sun Pharmaceutical Industries Limited at 1 site in United States.
Trial summary
This is an uncontrolled, open-label study being conducted in approximately 200 healthy males, non-pregnant, non-nursing females, age 12 to 45 years, with severe recalcitrant nodular acne. ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day will be administered for 4 weeks followed by 1.0 mg/kg/day for 16 weeks. Read more about this study
- Who is it for?
- Ages 12 to 45 years
- Conditions the study is for
- Acne
- What is being tested?
- Isotretinoin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2015to Apr 2018
- Phase
- Phase 4
- 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 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
None listed.
Who cannot join
- General Exclusion Criteria
- Presence of any clinically significant physical examination finding, vital signs measurement, or abnormal laboratory value;
- Presence of a beard or other facial hair that could interfere with the study assessments;
- Participated in another clinical trial or received an investigational product within 3 months prior to screening;
- History of excessive or suspected abuse of alcohol (based on the clinical judgment of the investigator), recreational drugs, and/or drugs of abuse, e.g., club drugs, cocaine, ecstasy/ methylenedioxymethamphetamine, heroin, inhalants, marijuana, methamphetamine, phencyclidine, prescription medications, anabolic steroids, etc.
- Use of prohibited or restricted prior or concomitant medications. Female Specific Exclusion Criteria
Show all 11Show fewer
- Are pregnant;
- Are at a high risk for becoming pregnant or likely to become pregnant during treatment;
- Are breast-feeding or considering breast-feeding during the course of the study;
- Have a known history of PCOS with another clinically significant abnormality (eg, metabolic syndrome or elevated lipids);
- Are unable or unwilling to maintain compliance with birth control measures
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Dermatology and Laser Specialists
San Antonio, Texas, 78218
About this study
Official title: An Open-label Study Evaluating the Long-term Efficacy, Quality of Life, and Safety of ABSORICA® (Isotretinoin) Capsules Administered Without Food in Patients With Severe Recalcitrant Nodular Acne
This is an uncontrolled, open-label study being conducted in approximately 200 healthy males, non-pregnant, non-nursing females, age 12 to 45 years, with severe recalcitrant nodular acne.
ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day will be administered for 4 weeks followed by 1.0 mg/kg/day for 16 weeks. Female subjects consenting to use two forms of birth control or abstinence are included.
Read the detailed description
This study is designed to collect efficacy, safety, and quality of life (QOL) data from subjects who receive Absorica® without food. The study will investigate the treatment efficacy, frequency of relapse once the treatment has been discontinued, quality of life during the active treatment and during a 2-year post treatment period and the overall safety of treatment with Absorica®.
This is a single-arm, open-label study consisting of 2 phases: a 20-week (5-month) open-label Active Treatment Period (ATP) and a 104-week (2-year) post treatment period (PTP). The total study duration is to be 124 weeks, excluding a screening period. During the ATP, after week 2 visit, visits will be scheduled at 4-week intervals for a total of 8 visits (1 screening visit, 1 baseline visit, and 6 on-study visits). During the PTP, the first visit will be 4 weeks after End of Treatment (EOT), the second visit will be 12 weeks after EOT, and subsequent visits will be scheduled at 26-week (± 2 weeks) intervals for a total of 6 visits.
- Conditions
- Acne
- Being tested
- Isotretinoin
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsotretinoinDrug
Also called ABSORICA
ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| Single treatment arm | Experimental | ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks. Receives: Drug: Isotretinoin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Active Treatment Period: Total Acne-Specific Quality of Life Score at Week 20
There are 4 domains: self-perception (22 questions), role-social (50 questions), role-emotional (33 questions), and acne symptoms (85 questions) in the acne-QOL questionnaires.
Calculation of the domain scores was accomplished by summing all item responses within each domain.
Self-perception: The range of possible scores is 0 to 30 points. Role-social: The range of possible scores is 0 to 24 points. Role emotional: The domain scores range from 0 to 30 points. Acne symptoms: The domain scores range from 0 to 30 points.
Measured: Week 20
Primary Efficacy Endpoint, Post-treatment Period: Subjects Requiring Retreatment During the Post-treatment Period and Time to Retreatment
subjects who were at least 75% compliant with their assigned treatment, had no major protocol violations, had a Week 20 count of total nodular lesions, and did not use any disallowed medications during the 20 weeks of treatment. (Retreated with Oral Isotretinoin Per Protocol Population).
Measured: 20 weeks
Secondary outcomes (15)
Active Treatment Period- Change From Baseline in Lesion Counts at Week 20
Change from baseline in the lesion count (nodules and inflammatory lesions) at the end of the ATP. (Per Protocol Population)
Measured: Baseline and at week 20
Active Treatment Period-Change From Baseline in Acne-Specific Quality of Life Total Score at Weeks 4, 8, 12, and 16
There are 4 domains: self-perception (22 questions), role-social (50 questions), role-emotional (33 questions), and acne symptoms (85 questions) in the acne-QOL questionnaires.
Calculation of the domain scores was accomplished by summing all item responses within each domain.
Self-perception: The range of possible scores is 0 to 30 points. Role-social: The range of possible scores is 0 to 24 points. Role emotional: The domain scores range from 0 to 30 points. Acne symptoms: The domain scores range from 0 to 30 points.
Measured: Baseline, at week 4, week 8, week 12, and week16
Active Treatment Period- Investigator's Global Assessment at Week 20
Investigator's Global Assessment score:
0 = Clear
- = Almost Clear
- = Mild
- = Moderate
- = Severe
- = Very Severe
Measured: week 20
Active Treatment Period- Change From Baseline in Acne-Specific Quality of Life Domain Scores by Domain at Weeks 4, 8, 12, and 16
Acne-Specific Quality of Life, by domain:
Self Perception: response on 0- to 6-point scale; the range of possible scores is 0 to 30 points.
Role-social: response on 0- to 6-point scale; the range of possible scores is 0 to 24 points.
Role-emotional: response on 0- to 6-point scale, exactly the same as those used for the Self Perception and Role-social domains.
Acne Symptoms:response on 0- to 6-point scale, domain scores range from 0 to 30 points
Measured: 20 weeks
Active Treatment Period- Change From Baseline in Nodule Count at Week 20
Measured: Baseline, and at week20
Post-treatment Period- Proportion of Subjects Requiring Treatment With Anti-Acne Medication and Time to Retreatment
Retreated with Prescription Anti-Acne Medication, n/Na (%); Over-the-Counter Anti-Acne Medication and Prescription or Over-the-Counter Anti-Acne Medication- Per Protocol Population.
Measured: 104 weeks
Post-treatment Period- Severity of Acne by Lesion Count at Time of Retreatment With Oral Isotretinoin
change from Baseline
Measured: 104 weeks
Post-treatment Period- Severity of Acne by Investigator's Global Assessment at Time of Retreatment With Oral Isotretinoin
Investigator's Global Assessment score:
0 = Clear
- = Almost Clear
- = Mild
- = Moderate
- = Severe
- = Very Severe
Measured: 104 weeks
Post-treatment Period- Severity of Acne by Lesion Count at Time of Retreatment With Prescription Other Than Oral Isotretinoin
Change from baseline
Measured: 104 weeks
Post-treatment Period- Severity of Acne by Investigator's Global Assessment Score at Time of Retreatment With Over-the-Counter Medication
Investigator's Global Assessment score:
0 = Clear
- = Almost Clear
- = Mild
- = Moderate
- = Severe
- = Very Severe
Measured: 20 weeks
Post-treatment Period-Severity of Acne by Lesion Count at Each Visit During the Post-treatment Period
Measured: week 124
Post Treatment Period- Severity of Acne by Nodule Count at Each Visit During the Post-treatment Period
Change from Baseline-Week 124
Measured: week 124
Severity of Acne by Investigator's Global Assessment Score at Each Visit During the Post-treatment Period
Investigator's Global Assessment score:
0 = Clear
- = Almost Clear
- = Mild
- = Moderate
- = Severe
- = Very Severe
Measured: week 124
Post-treatment Period- Severity of Acne by Lesion Count at Time of Retreatment With Over-the-Counter Medications
Change from Baseline
Measured: 20 weeks
Post Treatment Period-Severity of Acne by Investigator's Global Assessment Score at Time of Retreatment With Prescription Other Than Oral Isotretinoin
Investigator's Global Assessment score:
0 = Clear
- = Almost Clear
- = Mild
- = Moderate
- = Severe
- = Very Severe
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2015 (estimated)
- Study start21 Jan 2015
- Primary completionApr 2018
- Study completionApr 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AcneStudies of the same condition, open and under way.
- More trials run by Sun Pharmaceutical Industries LimitedThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Pharmaceutical Industries Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ashish Anvekar, MD, Study director, Ranbaxy Laboratories Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02457520
- Sponsor's protocol ID
- ABS157LT
- Status last verified
- Apr 2021
- First submitted
- 16 May 2015
- Last updated
- 27 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Del Rosso JQ, Stein Gold L, Segal J, Zaenglein AL. An Open-label, Phase IV Study Evaluating Lidose-isotretinoin Administered without Food in Patients with Severe Recalcitrant Nodular Acne: Low Relapse Rates Observed Over the 104-week Post-treatment Period. J Clin Aesthet Dermatol. 2019 Nov;12(11):13-18. Epub 2019 Nov 1.
PubMed 32038751
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Study Evaluating the Long-term Efficacy, Quality of Life, and Safety of ABSORICA® (Isotretinoin) Capsules Administered Without Food in Patients With Severe Recalcitrant Nodular Acne
- ClinicalTrials.gov ID
- NCT02457520
- Acronym / sponsor ID
- ABS157LT
- Conditions
- Acne
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries LimitedIndustry (pharma, biotech, devices)
- Study start
- 21 Jan 2015 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 29 May 2015 (estimated)
- Results
- Posted 27 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an uncontrolled, open-label study being conducted in approximately 200 healthy males, non-pregnant, non-nursing females, age 12 to 45 years, with severe recalcitrant nodular acne.
ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day will be administered for 4 weeks followed by 1.0 mg/kg/day for 16 weeks. Female subjects consenting to use two forms of birth control or abstinence are included.
Detailed description
This study is designed to collect efficacy, safety, and quality of life (QOL) data from subjects who receive Absorica® without food. The study will investigate the treatment efficacy, frequency of relapse once the treatment has been discontinued, quality of life during the active treatment and during a 2-year post treatment period and the overall safety of treatment with Absorica®.
This is a single-arm, open-label study consisting of 2 phases: a 20-week (5-month) open-label Active Treatment Period (ATP) and a 104-week (2-year) post treatment period (PTP). The total study duration is to be 124 weeks, excluding a screening period. During the ATP, after week 2 visit, visits will be scheduled at 4-week intervals for a total of 8 visits (1 screening visit, 1 baseline visit, and 6 on-study visits). During the PTP, the first visit will be 4 weeks after End of Treatment (EOT), the second visit will be 12 weeks after EOT, and subsequent visits will be scheduled at 26-week (± 2 weeks) intervals for a total of 6 visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single treatment arm | Experimental | Drug: IsotretinoinABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks. |
Who may qualify
- Ages
- 12 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (11 listed)
- General Exclusion Criteria
- Presence of any clinically significant physical examination finding, vital signs measurement, or abnormal laboratory value;
- Presence of a beard or other facial hair that could interfere with the study assessments;
- Participated in another clinical trial or received an investigational product within 3 months prior to screening;
- History of excessive or suspected abuse of alcohol (based on the clinical judgment of the investigator), recreational drugs, and/or drugs of abuse, e.g., club drugs, cocaine, ecstasy/ methylenedioxymethamphetamine, heroin, inhalants, marijuana, methamphetamine, phencyclidine, prescription medications, anabolic steroids, etc.
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 |
|---|---|---|
| IsotretinoinAlso: ABSORICAABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks | Drug | Single treatment arm |
Primary outcome
Active Treatment Period: Total Acne-Specific Quality of Life Score at Week 20
Time frame: Week 20
There are 4 domains: self-perception (22 questions), role-social (50 questions), role-emotional (33 questions), and acne symptoms (85 questions) in the acne-QOL questionnaires. Calculation of the domain scores was accomplished by summing all item responses within each domain. Self-perception: The range of possible scores is 0 to 30 points. Role-social: The range of possible scores is 0 to 24 points. Role emotional: The domain scores range from 0 to 30 points. Acne symptoms: The domain scores range from 0 to 30 points.
Primary Efficacy Endpoint, Post-treatment Period: Subjects Requiring Retreatment During the Post-treatment Period and Time to Retreatment
Time frame: 20 weeks
subjects who were at least 75% compliant with their assigned treatment, had no major protocol violations, had a Week 20 count of total nodular lesions, and did not use any disallowed medications during the 20 weeks of treatment. (Retreated with Oral Isotretinoin Per Protocol Population).
15 secondary outcomes
Active Treatment Period- Change From Baseline in Lesion Counts at Week 20
Time frame: Baseline and at week 20
Active Treatment Period-Change From Baseline in Acne-Specific Quality of Life Total Score at Weeks 4, 8, 12, and 16
Time frame: Baseline, at week 4, week 8, week 12, and week16
Active Treatment Period- Investigator's Global Assessment at Week 20
Time frame: week 20
Active Treatment Period- Change From Baseline in Acne-Specific Quality of Life Domain Scores by Domain at Weeks 4, 8, 12, and 16
Time frame: 20 weeks
Active Treatment Period- Change From Baseline in Nodule Count at Week 20
Time frame: Baseline, and at week20
Post-treatment Period- Proportion of Subjects Requiring Treatment With Anti-Acne Medication and Time to Retreatment
Time frame: 104 weeks
Post-treatment Period- Severity of Acne by Lesion Count at Time of Retreatment With Oral Isotretinoin
Time frame: 104 weeks
Post-treatment Period- Severity of Acne by Investigator's Global Assessment at Time of Retreatment With Oral Isotretinoin
Time frame: 104 weeks
Post-treatment Period- Severity of Acne by Lesion Count at Time of Retreatment With Prescription Other Than Oral Isotretinoin
Time frame: 104 weeks
Post-treatment Period- Severity of Acne by Investigator's Global Assessment Score at Time of Retreatment With Over-the-Counter Medication
Time frame: 20 weeks
Post-treatment Period-Severity of Acne by Lesion Count at Each Visit During the Post-treatment Period
Time frame: week 124
Post Treatment Period- Severity of Acne by Nodule Count at Each Visit During the Post-treatment Period
Time frame: week 124
Severity of Acne by Investigator's Global Assessment Score at Each Visit During the Post-treatment Period
Time frame: week 124
Post-treatment Period- Severity of Acne by Lesion Count at Time of Retreatment With Over-the-Counter Medications
Time frame: 20 weeks
Post Treatment Period-Severity of Acne by Investigator's Global Assessment Score at Time of Retreatment With Prescription Other Than Oral Isotretinoin
Time frame: 20 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32038751Del Rosso JQ, Stein Gold L, Segal J, Zaenglein AL. An Open-label, Phase IV Study Evaluating Lidose-isotretinoin Administered without Food in Patients with Severe Recalcitrant Nodular Acne: Low Relapse Rates Observed Over the 104-week Post-treatment Period. J Clin Aesthet Dermatol. 2019 Nov;12(11):13-18. Epub 2019 Nov 1.
- 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.
Ashish Anvekar, MD study director
Ranbaxy Laboratories Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Isotretinoin in people with Acne, run by Sun Pharmaceutical Industries 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 0 inclusion and 11 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 27 Apr 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 27 Apr 2021). 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?
Active Treatment Period: Total Acne-Specific Quality of Life Score at Week 20 (time frame: Week 20). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02457520, which also lists 1 linked publication.
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 27 Apr 2021.