Conditions: Actinic Keratosis
Keywords: Actinic Keratosis
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 22
Healthy volunteers: no

Brief 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 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.

Detailed description:

Arms:
arm 1: lidamycin phosphate and benzoyl peroxide 1.2%/3.75% combination gel; daily use for 99 days

Interventions: intervention 1: lidamycin phosphate and benzoyl peroxide 1.2%/3.75% combination
Intervention descriptions: intervention 1: 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).

Protocol document:
Prot_SAP_000.pdf: 
Improvement of perimenstrual acne with clindamycin phosphate 
and benzoyl peroxide 1.2%/3.75% combination gel 
PI: Anjali Vekaria 
NCT03122457 
Document Date: July 22, 2015


 
Protocol Title: 
Improvement of perimenstrual acne with clindamycin phosphate 
and benzoyl peroxide 1.2%/3.75% combination gel 
Principal Investigator 
Name/Contact Info:  
Anjali Shroff, MD 
Primary Contact 
Name/Contact Info 
Matthew Gagliotti +1 212.241.3288 
Date Revised: 
22 July 2015 
Study Number: 
HSM #15-00563 
 
1 
Revised 12 May 2015 
MSSM Protocol Template HRP-503 
• 
Note that, depending on the nature of your research, certain questions, directions, or entire sections below 
may not be applicable. Provide information if and when applicable, and in cases where an entire section is not 
applicable, indicate this by marking the section “N/A”. Do not delete any sections. 
• 
For any items below that are already described in the sponsor’s protocol, the investigator’s protocol, the 
grant application, or other source documents, you may simply reference the title and page numbers of 
these documents in the sections below, rather than cutting and pasting into this document. Do not refer to 
the Sample Consent document, or information on the application form in this document. 
• 
Keep an electronic copy of this version of the document. You will need to modify this copy when making 
changes. 
 
 
Brief Summary of Research (250-400 words): 
We plan to enroll a total of 40 subjects with perimenstrual acne. Eligible women will be over the 
age of 18 and not on any current therapy. They 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). Their 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 day of their menses (as studies indicate that most women have their acne 
flare during this time). We 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). They will then return in 2 weeks, at day 15, and they will be re-
assessed. They will be dispensed the investigational product and instructed on its daily use. They 
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 we anticipate an enrollment period of 12 months. 
1) Objectives: 
In this study, we will look at the effectiveness of clindamycin phosphate and benzoyl 
peroxide 1.2%/3.75% combination gel for perimenstrual acne. The gel is the first and only 
FDA-approved fixed combination of 1.2% clindamycin phosphate and 3.75% benzoyl 
peroxide medication, and has been proven effective in the treatment of comedonal (non-
inflammatory) and inflammatory acne when used once daily. We hope to demonstrate its 
effectives as a single agent in treating perimenstrual acne. 
 
 


 
Protocol Title: 
Improvement of perimenstrual acne with clindamycin phosphate 
and benzoyl peroxide 1.2%/3.75% combination gel 
Principal Investigator 
Name/Contact Info:  
Anjali Shroff, MD 
Primary Contact 
Name/Contact Info 
Matthew Gagliotti +1 212.241.3288 
Date Revised: 
22 July 2015 
Study Number: 
HSM #15-00563 
 
2 
Revised 12 May 2015 
2) Background 
Acne is an extremely common dermatologic problem, affecting over 17 million individuals in 
the United States. While it is typically thought of as a disorder affecting adolescents, many 
individuals continue to have acne or first develop acne in adulthood. Among those over the 
age of 20, acne is more commonly seen in females than in males, and in this female 
population it is often perceived as perimenstrual. One study performed at Mount Sinai 
demonstrated that of 105 adult women with acne, 65% felt that their acne worsened 
perimenstrually. 
 
Due to the significant role of androgens in the development of perimenstrual acne, hormonal 
therapy with oral contraceptive pills or spironolactone has long been a mainstay of treatment. 
Yet for many women, these therapies are problematic due to their side effects, stigma, or pill 
burden. Topical treatments are often used as well; however, at present no topical therapy has 
been demonstrated to be more effective in women with this type of hormonal acne.  
3) Setting of the Human Research 
Subjects will attend their study visits in the outpatient offices at the FPA, 5th floor, 
Department of Dermatology. 
4) Resources Available to Conduct the Human Research 
In the past we never have had any difficulty recruiting potential study patients, particularly 
for studies that focus upon acne. We will mostly rely on our database of potential subjects 
who have requested to be contacted for future studies. In addition, we have a very active 
referral base from the in-house residents, and affiliated attendings. Thus, the recruitment of 
the 40 required subjects for this study should not be difficult, and our timelines should be met 
with ease. 
 
Our staff is very well versed and experienced in conducting clinical trials. For further 
information, please locate the PI and sub-investigators’ Curriculum Vitae. 
 
All Persons assisting with the trial have copies of the protocol, and knowledge of the study 
drugs involved in the trial.  
 
 
 
 
 


 
Protocol Title: 
Improvement of perimenstrual acne with clindamycin phosphate 
and benzoyl peroxide 1.2%/3.75% combination gel 
Principal Investigator 
Name/Contact Info:  
Anjali Shroff, MD 
Primary Contact 
Name/Contact Info 
Matthew Gagliotti +1 212.241.3288 
Date Revised: 
22 July 2015 
Study Number: 
HSM #15-00563 
 
3 
Revised 12 May 2015 
5) Study Design 
a) Recruitment Methods 
Potential subjects will come from our database of patients who have requested to be 
contacted for future studies, and they will be referred by in-house residents and affiliated 
attendings. In addition, IRB approved advertisements will be used. 
b) Inclusion and Exclusion Criteria 
Please see page 3 of the protocol under sections, « Inclusion Criteria » and « Exclusion 
Criteria ». 
c) Number of Subjects 
Forty people are expected to take part in this clinical trial. This is a single-center study, which 
will only be conducted at Mount Sinai.  
d) Study Timelines 
The study duration for each subject will be 99 days. We anticipate beginning enrollment in 
August 2015, and expect to complete the enrollment of all 40 subjects by June 2016. 
Therefore, the last patient visit should occur in October 2016. We will require another 2-3 
months to complete all data analyses. We expect to complete the entire study, including 
analyses by  January 2017. 
e) Study Endpoints 
Please see page 7 of the protocol under section, « Efficacy Endpoints ».  
f) Procedures Involved in the Human Research 
Please see page 4 of the protocol under section, « Study Methodology ». 
 
The subject’s medical history and any concomitant or past medications/ therapies will be 
collected from the patient via his/her recollection. No chart review will be performed. 
 
Provided subject consent, photographs will be taken at each visit. Digital photographs of the 
subject will be taken to record the location and extent of acne. Photo consent is not 
mandatory for participation in this study. If the photos are used in publications, the eyes will 
be blackened out to protect the identity of the subjects.  
 
Female subjects of childbearing potential must consent to a urine pregnancy test. 


 
Protocol Title: 
Improvement of perimenstrual acne with clindamycin phosphate 
and benzoyl peroxide 1.2%/3.75% combination gel 
Principal Investigator 
Name/Contact Info:  
Anjali Shroff, MD 
Primary Contact 
Name/Contact Info 
Matthew Gagliotti +1 212.241.3288 
Date Revised: 
22 July 2015 
Study Number: 
HSM #15-00563 
 
4 
Revised 12 May 2015 
 
g) Specimen Banking 
N/A 
 
h) Data Management and Confidentiality 
All records, including photographs, identifying the subject will be kept confidential and, to 
the extent permitted by the applicable laws and/or regulations, will not be made publicly 
available. Subject names will not be supplied to the sponsor. Only the subject number will be 
recorded in the CRF, and if the subject name appears on any other document, it must be 
obliterated before a copy of the document is supplied to the sponsor. Study findings stored on 
a password protected computer will be encrypted and stored in accordance with local data 
protection laws. Only the PI, sub-investigators, and main study coordinator (back-up 
coordinator, if applicable) will have access to the data that is collected. As part of the 
informed consent process, the subjects will be informed in writing that representatives of the 
sponsor, IRB, or regulator authorities may inspect their medical records to verify the 
information collected, and that all personal information made available for inspection will be 
handled in strictest confidence and in accordance with local data protection laws. If the 
results of the study are published, the subject’s identity will remain confidential. Only the 
investigator will maintain a list to enable subjects to be identified. 
i) Provisions to Monitor the Data to Ensure the Safety of subjects 
This information is only required when Human Research involves more than Minimal risk to 
subjects. 
Part I describes the safety monitoring activities that will be undertaken in during the study. 
This should be completed for all studies that require more than the basic minimum DSMP. 
Part II describes Data and Safety Monitoring Committees or Boards and should be 
completed when one is needed for the DSMP 
Part I: Elements of a Data and Safety Monitoring Plan 
1. List the name(s) of the individual(s) at MSSM who will be responsible for data and safety 
monitoring of this study. For each individual, indicate their role, name, title, and 
department information. The Principal Investigator may be the only monitor of a study. If 
the qualifications of an individual to serve as a monitor are not contained in the PPHS 
application, they must be added to the DSMP either as a narrative description or as a 
CV. 
 
 


 
Protocol Title: 
Improvement of perimenstrual acne with clindamycin phosphate 
and benzoyl peroxide 1.2%/3.75% combination gel 
Principal Investigator 
Name/Contact Info:  
Anjali Shroff, MD 
Primary Contact 
Name/Contact Info 
Matthew Gagliotti +1 212.241.3288 
Date Revised: 
22 July 2015 
Study Number: 
HSM #15-00563 
 
5 
Revised 12 May 2015 
MSSM Principal Monitor: 
Indicate whether this person is the PI, a Team Member, or is Independent: Last Name: 
Goldenberg 
First Name: Gary 
Academic Title: Assistant Professor 
Department: Dermatology  
Mailing Address: 
 
 
; New York, NY 10029 USA 
Phone: +1 212.241.3288 
Fax: N/A 
Email: gary.goldenberg@mounsinai.org 
 
MSSM Additional Monitor:  
 
 
 
 
                                             
Indicate whether this person is the PI, a Team Member, or is Independent:                           
Last Name: Shroff 
 
 
 
 
 
 
                                                     
First Name: Anjali 
 
 
 
 
 
                                            
Academic Title: Dermatopharmacology research fellow 
 
 
 
                                 
Department: Dermatology    
 
 
 
 
 
 
 
Mailing Address: 
 
 
; New York, NY 10029 USA                                                      
Phone: +1 212.241.3288                                        
  
 
                                                  
Fax: N/A 
 
 
 
 
 
 
                                                  
Email: Anjali.shroff@mssm.edu 
 
1. The principal monitor is the most experienced investigator on this study. Please refer to 
respective curriculum vitae for further information. 
2. Please see protocol page 6, under «Safety Evaluations». Early termination subjects will be 
asked for one last follow-up to track their final progress. Safety and AEs will be assessed at 
each visit. 
3. The sum of safety data will be analyzed upon stud completion, as this is a short-term study. 
Any significant safety data will be reported to the sponsor. 
4. With regards to subject withdrawal or discontinuation, subjects may choose to withdraw 
from the study or be withdrawn by the investigator at any time without prejudice to their 
future medical care. Any subject who does not comply with the inclusion/exclusion criteria 
may be withdrawn from further participation in the study. Any subject who receives study 
product and discontinues prematurely from the study should return to the stud center for an 
End of Study Visit.  
5. N/A 
6. Adverse events will be recorded on the source for each patient during each study visit. A 
local skin reaction grading system will be used for recording the severity of adverse events.  
7. Each sub-investigator will sign/initial the source sheet for each visit after ensuring that all 
the required data is recorded accurately. 
8. Should a temporary or permanent suspension of your stud occur, in addition to the PPHS, 
we will report the occurrence to the IRB. 


 
Protocol Title: 
Improvement of perimenstrual acne with clindamycin phosphate 
and benzoyl peroxide 1.2%/3.75% combination gel 
Principal Investigator 
Name/Contact Info:  
Anjali Shroff, MD 
Primary Contact 
Name/Contact Info 
Matthew Gagliotti +1 212.241.3288 
Date Revised: 
22 July 2015 
Study Number: 
HSM #15-00563 
 
6 
Revised 12 May 2015 
j) Withdrawal of Subjects 
Any subject who discontinues, for any reason, will be encouraged to return for a final visit in 
order to collect safety data (disease assessment (PGA); photographs; adverse event 
assessment; concomitant medication documentation). 
6) Risks to Subjects 
Risks from the study drug commonly include: burning sensations, contact dermatitis, 
pruritus, and rash in the treatment area. Additionally, although uncommon, systemic 
absorption of clindamycin (clindamycin being absorbed through your skin into your blood) 
has been reported following its topical use. Diarrhea, bloody diarrhea, and colitis have been 
reported with the use of topical and systemic clindamycin. If significant diarrhea occurs, the 
study drug should be discontinued. 
Allergic reactions, including anaphylaxis, have also rarely been reported.  
Risk of loss of private information; this risk always exists, but there are procedures in place to 
minimize the risk.   
If you are or become pregnant, this research may hurt your baby or your pregnancy in ways 
that are unknown. The unknown risks might be minor or might be major (death). You should 
not become pregnant while you are on this research study.  
In addition to these risks, this research may hurt you in ways that are not known.  The 
unknown risks might be minor or might be major (death). 
7) Provisions for Research Related Injury 
If a subject is injured or made sick from taking part in this research study, medical care will 
be provided. Generally, this medical care will be billed to the subject and/or the subject’s 
health care insurance. In some cases, the costs of this care may be paid by someone else. In 
the event of injury, contact the Principal Investigator.  
 
If the subject follows the directions of the study doctor and staff and the subject is physically 
injured because of a properly given drug, or procedures necessary for this study, the sponsor 
will pay the medical expenses for the treatment of that injury which are not covered by the 
subject’s medical insurance, by a government program, or by any other third party. 
8) Potential Benefits to Subjects 
Since the study drug being used commonly treats acne, there is a reasonable chance that this 
study may benefit the subjects. The possible benefit is that the subjects’ acne may clear. 
9) Provisions to Protect the Privacy Interests of Subjects 
All results and data will be collected and analyzed within Mount Sinai. Patient documents 
will be stored in a secure place. Staff at Mount Sinai school of Medicine Dermatology 
Clinical Trials department has to undergo IRB and HIPAA training. Only the investigators, 


 
Protocol Title: 
Improvement of perimenstrual acne with clindamycin phosphate 
and benzoyl peroxide 1.2%/3.75% combination gel 
Principal Investigator 
Name/Contact Info:  
Anjali Shroff, MD 
Primary Contact 
Name/Contact Info 
Matthew Gagliotti +1 212.241.3288 
Date Revised: 
22 July 2015 
Study Number: 
HSM #15-00563 
 
7 
Revised 12 May 2015 
sub-investigators and study coordinator will have access to this data. Patient photographs will 
be stored in a secure folder that only people listed in the study will have access to. 
 
Only subjects who have given us permission to contact them for studies will be contacted. All 
conversations with subjects and potential subjects will be conducted in a private examination 
room with the subject. Family members will be allowed to remain in the room only if the 
subject allows it. If the subject must be contacted by phone, then the study staff will only 
speak to the subject, and if a message is required, no information regarding the subject’s 
disease, treatment or the fact that he/she is involved in a study will be conveyed.  
10) 
Economic Impact on Subjects 
Patients will be compensated $25 per study visit for transportation, excluding screening. 
The study medications will be of no cost to the subject. 
11) 
Payment to Subjects 
Subjects will be paid $25 per study visits 1-8 totaling $125. Since this is a short study, 
subjects will be paid upon completion. 
Subjects who do not complete all study visits will be compensated for those which have 
been completed.  
12) 
Consent Process 
HRP-090 Informed Consent Process for Research will be followed. 
 
The Consent will be obtained prior to any study procedures and administered by the Principal 
Investigator or delegates. The consent process will be performed either at the first visit to the 
study site (not necessarily the first stud visit as specified in the protocol) or should the subject 
prefer to take the consent home to read at leisure, at a subsequent visit. Consent will be 
obtained in a private, closed-door patient room which will not permit others to overhear the 
consent process. The Screening Visit will occur immediately after consent is obtained. No 
study procedures will be performed until written consent is provided. 
 
If necessary, in cases where the subject does not speak/read English, a translator will be used 
and an IRB approved consent form in his/her native language will be used. If a potential 
subject requires a consent form in a specific language which cannot be obtained, that that 
subject will not be eligible to participate in this stud. The Screening Visit will occur 
immediately after consent is obtained. No study procedures will be performed until written 
consent is provided. 
 
Subjects are required to provide their date of birth at the first visit. We use this information to 
document the subject’s legal age. If we feel a date is questionable we ask for a photo ID. 
Should the subjects have a birthday that makes them under 18 years of age the will not be 
enrolled in this study. 


 
Protocol Title: 
Improvement of perimenstrual acne with clindamycin phosphate 
and benzoyl peroxide 1.2%/3.75% combination gel 
Principal Investigator 
Name/Contact Info:  
Anjali Shroff, MD 
Primary Contact 
Name/Contact Info 
Matthew Gagliotti +1 212.241.3288 
Date Revised: 
22 July 2015 
Study Number: 
HSM #15-00563 
 
8 
Revised 12 May 2015 
13) 
Process to Document Consent in Writing 
This study will be using the standard PPHS consent template. 
14) 
Vulnerable Populations 
Indicate specifically whether you will include (target) or exclude each of the following 
populations: 
 
Include 
Exclude 
Vulnerable Population Type 
 
√ 
Adults unable to consent 
 
√ 
Individuals who are not yet adults (e.g. infants, infants, 
teenagers) 
 
√ 
Wards of the State (e.g. foster children) 
 
√ 
Pregnant women 
 
√ 
Prisoners 
 
 
15) 
Multi-Site Human Research (Coordinating Center) 
N/A 
16) 
Community-Based Participatory Research 
N/A 
17) 
Sharing of Results with Subjects 
It is a requirement that the study subject’s involvement in this study be noted in his or her 
medical records. If the study subject’s primary care physician is different from the study 
doctor for this study, the PCP may also be notified of the subject’s involvement in this 
study. 
 
Direct access to the study subject’s records will be require by authorized representatives 
of the sponsor to check the information collected for the study. Medical records may also 
be reviewed and copies made by members of either the institutional review 


 
Protocol Title: 
Improvement of perimenstrual acne with clindamycin phosphate 
and benzoyl peroxide 1.2%/3.75% combination gel 
Principal Investigator 
Name/Contact Info:  
Anjali Shroff, MD 
Primary Contact 
Name/Contact Info 
Matthew Gagliotti +1 212.241.3288 
Date Revised: 
22 July 2015 
Study Number: 
HSM #15-00563 
 
9 
Revised 12 May 2015 
board/independent ethics committee responsible for this study site, regulatory agencies in 
countries where approval for the investigational products may be sought and/or 
authorized representatives of the sponsor. These individuals will see the subject’s name, 
other personal information such as date of birth and gender, and medical information, but 
should not disclose the subject’s name to anyone else. However, because of the need for 
these parties to have access to medical information, absolute confidentiality cannot be 
guaranteed. 
 
18) 
IRB Review History 
N/A 
19) 
Control of Drugs, Biologics, or Devices 
Study drug is stored in a temperature-controlled, combination-locked room accessible 
only by clinical trials personnel. It will be dispensed to eligible subjects by PI-delegated 
study personnel.