Actinic KeratosisPhase 2NCT03122457
Perimenstrual Acne With Clindamycin Phosphate and Benzoyl Peroxide
A Phase 2 study testing lidamycin phosphate and benzoyl peroxide 1.2%/3.75% combination in people with Actinic Keratosis, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
The study team plans to enroll a total of 40 subjects with self-reported perimenstrual acne. Eligible women will be over the age of 18 and not on any current therapy. The patients will first arrive for a screening visit, where they will be given questionnaires on acne quality of life (acne QOL) and subjective… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Actinic Keratosis
- What is being tested?
- lidamycin phosphate and benzoyl peroxide 1.2%/3.75% combination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2017to 19 Jul 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women 18 years or older
- Women who have had their first menses at least 12 months ago, and who currently have regular menses.
- Subjects must be able to read and understand English, and be able and willing to complete the survey.
- Subjects must have a self-reported complaint of peri-menstrual acne which has occurred monthly for the last 6 months.
- Subjects must be willing to forego any other therapy to the treatment area for the duration of the study.
- Subject is willing and able to participate in the study as an outpatient, making frequent visits to the study center during the treatment and follow-up periods and to comply with all study requirements including concomitant medication and other treatment restrictions.
- Subjects must have a negative urine pregnancy test result prior to study treatment initiation and must agree to use an approved method of birth control while enrolled in the study.
- Subjects must be willing to use a form of birth control during the study. For the purpose of this study, the following are considered acceptable methods of birth control: oral contraceptives, Norplant, Depo-Provera, double barrier methods (e.g., condom and spermicide) and abstinence.
Who cannot join
- Male subjects.
- Post-menopausal women.
- Women who do not suffer from acne.
- Subjects who are allergic to clindamycin, benzoyl peroxide, lidocaine or any other ingredients listed in the study medication.
- Subjects with an unstable medical condition as deemed by the clinical investigator.
- Subjects with ulcerative colitis or Crohn's disease.
Show all 10Show fewer
- Subjects with any dermatologic disease in the treatment area that may be exacerbated by the treatment proposed or that might impair the evaluation of acne.
- Women who are pregnant, lactating, or planning to become pregnant during the study period.
- Subjects who have used any topical prescription medications on the study area within 30 days prior to Visit 2 / Baseline.
- Subjects on a stable dose of oral contraceptives for less than 6 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Improvement of Perimenstrual Acne With Clindamycin Phosphate and Benzoyl Peroxide 1.2%/3.75% Combination Gel
The study team plans to enroll a total of 40 subjects with self-reported perimenstrual acne. Eligible women will be over the age of 18 and not on any current therapy. The patients will first arrive for a screening visit, where they will be given questionnaires on acne quality of life (acne QOL) and subjective assessments as well as flare ups (as used in the study by Geller et al). The patients' skin will be assessed for inflammatory and non-inflammatory acne vulgaris. The baseline visit (day 1) will be scheduled for one week prior to the first day of menses (as studies indicate that most women have their acne flare during this time). The study team will perform a zit count (counting papules, pustules, and comedones) and global assessment, and the patient will be instructed to record their menses (which they will do for the duration of the study). The patients will then return in 2 weeks, at day 15, and they will be re-assessed. The patients will be dispensed the investigational product and instructed on its daily use. The patients will continue to return every 14 days to have their skin assessed until their final visit on day 99, one week after their 3rd menses on treatment (4th menses on study). The duration of the study per patient is approximately 4 months, and the study team anticipates an enrollment period of 12 months.
- Conditions
- Actinic Keratosis
- Being tested
- lidamycin phosphate and benzoyl peroxide 1.2%/3.75% combination
- Keywords
- Actinic Keratosis
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lidamycin phosphate and benzoyl peroxide 1.2%/3.75% combinationDrug
At Day 15, patients will be re-assessed and dispensed the investigational product and instructed on its daily use. Patients will continue to return every 14 days to have their skin assessed until their final visit on day 99, one week after their 3rd menses on treatment (4th menses on study).
| Study group | Role | What they receive |
|---|---|---|
| lidamycin phosphate and benzoyl peroxide 1.2%/3.75% combo | Experimental | lidamycin phosphate and benzoyl peroxide 1.2%/3.75% combination gel; daily use for 99 days Receives: Drug: lidamycin phosphate and benzoyl peroxide 1.2%/3.75% combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
PGA Score
Treatment Success defined as a score of 0 (clear) to 1 (almost clear) at day 99 (final study visit) by acne PGA scoring system. Full PGA scale from 0-5, with lower score indicating better drug efficacy
Measured: Day 99
Secondary outcomes (1)
Adverse Event Severity
Safety/drug-tolerance evaluated by subject-reported adverse events as well as physician evaluated erythema, scaling, drying, and stinging/burning on a 0-3 point scale, where 0=none and 3=severe.
Measured: Day 99
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2017
- Study start1 Jan 2017
- Primary completion19 Jul 2018
- Study completion19 Jul 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 Actinic KeratosisStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Application of clindamycin phosphate and benzoyl peroxide 1.2%/3.75% combination gel to treat perimenstrual acne
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Bausch Health Americas, Inc.
- Responsible party
- Principal investigator, Anjali Vekaria, Icahn School of Medicine at Mount Sinai
- Investigators
- Anjali Shroff, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03122457
- Sponsor's protocol ID
- GCO 15-1230
- Status last verified
- Aug 2020
- First submitted
- 17 Apr 2017
- Last updated
- 4 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Perimenstrual Acne With Clindamycin Phosphate and Benzoyl Peroxide 1.2%/3.75% Combination Gel
- ClinicalTrials.gov ID
- NCT03122457
- Acronym / sponsor ID
- GCO 15-1230
- Conditions
- Actinic Keratosis
- Keywords
- Actinic Keratosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Bausch Health Americas, Inc.
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 19 Jul 2018 (actual)
- Study completion
- 19 Jul 2018 (actual)
- First posted
- 20 Apr 2017 (actual)
- Results
- Posted 4 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study team plans to enroll a total of 40 subjects with self-reported perimenstrual acne. Eligible women will be over the age of 18 and not on any current therapy. The patients will first arrive for a screening visit, where they will be given questionnaires on acne quality of life (acne QOL) and subjective assessments as well as flare ups (as used in the study by Geller et al). The patients' skin will be assessed for inflammatory and non-inflammatory acne vulgaris. The baseline visit (day 1) will be scheduled for one week prior to the first day of menses (as studies indicate that most women have their acne flare during this time). The study team will perform a zit count (counting papules, pustules, and comedones) and global assessment, and the patient will be instructed to record their menses (which they will do for the duration of the study). The patients will then return in 2 weeks, at day 15, and they will be re-assessed. The patients will be dispensed the investigational product and instructed on its daily use. The patients will continue to return every 14 days to have their skin assessed until their final visit on day 99, one week after their 3rd menses on treatment (4th menses on study). The duration of the study per patient is approximately 4 months, and the study team anticipates an enrollment period of 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Application of clindamycin phosphate and benzoyl peroxide 1.2%/3.75% combination gel to treat perimenstrual acne
| Arm | Type | Receives |
|---|---|---|
| lidamycin phosphate and benzoyl peroxide 1.2%/3.75% combo | Experimental | Drug: lidamycin phosphate and benzoyl peroxide 1.2%/3.75% combinationlidamycin phosphate and benzoyl peroxide 1.2%/3.75% combination gel; daily use for 99 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Women 18 years or older
- Women who have had their first menses at least 12 months ago, and who currently have regular menses.
- Subjects must be able to read and understand English, and be able and willing to complete the survey.
- Subjects must have a self-reported complaint of peri-menstrual acne which has occurred monthly for the last 6 months.
- Subjects must be willing to forego any other therapy to the treatment area for the duration of the study.
Key exclusion criteria (10 listed)
- Male subjects.
- Post-menopausal women.
- Women who do not suffer from acne.
- Subjects who are allergic to clindamycin, benzoyl peroxide, lidocaine or any other ingredients listed in the study medication.
- Subjects with an unstable medical condition as deemed by the clinical investigator.
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 |
|---|---|---|
| lidamycin phosphate and benzoyl peroxide 1.2%/3.75% combinationAt Day 15, patients will be re-assessed and dispensed the investigational product and instructed on its daily use. Patients will continue to return every 14 days to have their skin assessed until their final visit on day 99, one week after their 3rd menses on treatment (4th menses on study). | Drug | lidamycin phosphate and benzoyl peroxide 1.2%/3.75% combo |
Primary outcome
PGA Score
Time frame: Day 99
Treatment Success defined as a score of 0 (clear) to 1 (almost clear) at day 99 (final study visit) by acne PGA scoring system. Full PGA scale from 0-5, with lower score indicating better drug efficacy
1 secondary outcome
Adverse Event Severity
Time frame: Day 99
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 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.
Anjali Shroff, MD principal investigator
Icahn School of Medicine at Mount Sinai
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 lidamycin phosphate and benzoyl peroxide 1.2%/3.75% combination in people with Actinic Keratosis, run by Icahn School of Medicine at Mount Sinai 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 10 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 4 Sep 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. 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 4 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?
PGA Score (time frame: Day 99). 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 4 Sep 2020.