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Weekly Isotretinoin Therapy Study (WIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04594759
Recruitment Status : Completed
First Posted : October 20, 2020
Results First Posted : May 9, 2022
Last Update Posted : May 9, 2022
Sponsor:
Information provided by (Responsible Party):
Samantha Karlin, MD, Medical University of South Carolina

Brief Summary:
In current Dermatology practice, options for moderate acne vulgaris remain limited. The mainstay of treatment for moderate acne remains long courses of oral antibiotics despite emerging antibiotic resistance. The efficacy of daily to twice daily dosed isotretinoin, an oral vitamin A derivative, for treatment of severe acne has been well established. The purpose of this study is to determine if once weekly dosed isotretinoin is effective for the treatment of patients with moderate acne. Additionally, the study aims to evaluate patient satisfaction and identify any adverse effects on this alternative dosing regimen.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: Isotretinoin Phase 1 Phase 2

Detailed Description:

In current Dermatology practice, options for moderate acne vulgaris remain limited. Moderate acne is clinically defined as acne that has not responded to at least three months of topical therapy and is not severe enough for initial treatment with a conventional course of isotretinoin (formerly known as Accutane). The mainstay of treatment for moderate acne remains long courses of oral antibiotics, mainly tetracyclines (doxycycline, minocycline) and occasionally trimethoprim-sulfamethoxazole. Males with moderate acne, in particular, are especially limited in their treatment options as they are not eligible for hormonal management (spironolactone, oral contraceptive pills) like their female counterparts. Additionally, even for those regardless of gender who may eventually qualify for a traditional isotretinoin course, many insurance companies first require failure to respond to at least three months of oral antibiotics. Nagler et. al found that the average antibiotic use for moderate to severe acne prior to receiving isotretinoin was 331 days, with 15.3% of patients prescribed antibiotics for three months or less, 88% for six months or more, and 46% for at least one year.1 Despite the widespread use of oral antibiotics in acne, antibiotic resistance is considered a global threat per the CDC2, and there have been calls to limit their use in acne because of concerns of bacterial resistance3,4,5. Because of this, there is a significant need for more research on alternative treatment options for moderate acne.

Once weekly isotretinoin dosing has the potential to significantly improve moderate acne with good patient satisfaction and safety profile; however, no study findings on this treatment option have been published to date. The efficacy of isotretinoin, an oral vitamin A derivative, for treatment of acne has been well established. The traditional treatment course for severe acne consists of once to twice daily dosing (0.5-1 mg/kg/day) for 4-7 months (or 150mg/kg total cumulative dose). Though efficacious, there are numerous reported side-effects due to achieving the cumulative dose rapidly by once to twice daily dosing, such as severe dry skin, lips, and eyes, as well as liver enzyme and lipid abnormalities. Because of this, there have been studies exploring alternative isotretinoin dosing regimens including microdose, lower daily dose regimens (0.15-0.4 mg/kg/day6, 0.25-0.4 mg/kg/day7, 0.3-0.4 mg/kg/day8,9, in addition to 5 mg/day10 and 0.15-0.28 mg/kg/day with additional of local application of 1% clindamycin gel every other day11) and daily dosing for 7-10 consecutive days (0.5-0.7 mg/kg/day) out of each month only.7,12,13,14 All studies had favorable outcomes with alternative dosing, despite the lower total cumulative dose versus conventional dosing. Those who also analyzed adverse effect rates with alternative isotretinoin dosing found that these were either rarely observed or similar to conventional dosing.6,8,9,10,12,14 In contrast, the potential adverse effects of oral antibiotics used for acne include photosensitivity and nausea/vomiting (doxycycline), drug-induced pigment deposition and drug-induced systemic lupus erythematosus (minocycline), and angioedema and drug rashes including drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome (trimethoprim-sulfamethoxazole). Interestingly, rates of acne recurrence between alternative isotretinoin dosing and conventional dosing were similar at follow-up,6,7,9 despite a much older study from 1984 that found otherwise.15 Additionally, cost of alternative isotretinoin dosing was lower than with conventional dosing,8,9,13 and patient satisfaction was highest in the alternative dosing groups.7,10 For these reasons, this study aims to evaluate the efficacy of once weekly isotretinoin dosing (1-1.5 mg/kg/week) as a potential alternative to oral antibiotics for the treatment of patients with moderate acne. Secondary endpoints include patient satisfaction and adverse effects.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: The study member assessing change in acne using the Comprehensive Acne Severity Scale does not know the medication the participants are taking.
Primary Purpose: Treatment
Official Title: Weekly Isotretinoin Therapy for the Treatment of Moderate Acne Vulgaris
Actual Study Start Date : November 11, 2020
Actual Primary Completion Date : December 21, 2021
Actual Study Completion Date : December 21, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: Treatment Group Drug: Isotretinoin
Participants will be getting isotretinoin (1-1.5 mg/kg/week)




Primary Outcome Measures :
  1. Number of Participants That Showed Improvement in Their Visible Acne (Efficacy of Once Weekly Isotretinoin) [ Time Frame: Baseline and end of treatment, approximately 4 months ]
    Will look at clinical photos before, during, and after treatment and grade acne using a validated, clinical grading system (Comprehensive Acne Severity Scale, CASS) with "0" being clear skin and "5" being very severe acne. Participants are eligible for the study if their score is 3 or higher. An improvement in their visible acne is a score of 2, 1, or 0 at the end of the 4 months of treatment.


Secondary Outcome Measures :
  1. Number of Participants With a Change in Quality of Life [ Time Frame: Baseline, monthly, and end of treatment, total of 4 months ]
    Participants will use the Dermatology Life Quality Index survey which measures how much their skin problems affect their life. 10 questions are asked with answers "Very much," " A lot," "A little," "Not at all," or "Not relevant". The answers correlate to a number ("Very much" =3, " A lot" = 2, "A little"=1, "Not at all"= 0, "Not relevant"=0) and the answered are added together to get a score for that month. The higher the score the more their skin impacts their day to day activities. An improvement in their quality of life is a lower score at 4 months compared to baseline score.

  2. Number of Side Effects Reported at the End of 4 Months [ Time Frame: through study completion, an average of 4 months ]
    Participants will fill out a survey regarding nonserious and serious adverse events.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients 12 years and older with the diagnosis of moderate acne vulgaris

Exclusion Criteria:

  • Patients who are at baseline on long-term tetracycline antibiotics, long-term trimethoprim-sulfamethoxazole, or on spironolactone for any reason
  • Patients who have taken isotretinoin in the past 6 months
  • Patients with hypersensitivity to isotretinoin or to any of its components
  • Females who are pregnant, likely to become pregnant, or will be breast-feeding during the study period
  • Patients with a history of major depression, mania, or psychosis with an active episode during the past year including current psychotic symptoms and/or current suicidal ideation
  • Adult patients with cognitive impairment
  • Patients with baseline kidney or liver disease
  • Patients with baseline hypertriglyceridemia
  • Patients with history of or current pseudotumor cerebri
  • Patients with any clinically significant unstable medical condition which could pose a risk to the safety of the patient
  • Inability or unwillingness of subject or legal guardian/representative to give informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04594759


Locations
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United States, South Carolina
Samantha Karline
Charleston, South Carolina, United States, 29403
Sponsors and Collaborators
Medical University of South Carolina
Investigators
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Principal Investigator: Samantha Karlin, MD Medical University of South Carolina
  Study Documents (Full-Text)

Documents provided by Samantha Karlin, MD, Medical University of South Carolina:
Study Protocol  [PDF] November 12, 2020
No Statistical Analysis Plan (SAP) exists for this study.

Publications:
Center for Disease Control (https://www.cdc.gov/drugresistance/biggest-threats.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fdrugresistance%2Fbiggest_threats.html)

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Responsible Party: Samantha Karlin, MD, Dermatology Resident Principal Investigator, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT04594759    
Other Study ID Numbers: 00103493
First Posted: October 20, 2020    Key Record Dates
Results First Posted: May 9, 2022
Last Update Posted: May 9, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The individual participant data collected during the study after de-identification
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Analytic Code
Time Frame: Immediately following publication, indefinitely

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Isotretinoin
Dermatologic Agents