Weekly Isotretinoin Therapy Study

NCT04594759 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 00103493
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

• Number of Participants That Showed Improvement in Their Visible Acne (Efficacy of Once Weekly Isotretinoin)

  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.

  Baseline and end of treatment, approximately 4 months

Secondary Outcomes (2)

• Number of Participants With a Change in Quality of Life

  Baseline, monthly, and end of treatment, total of 4 months

• Number of Side Effects Reported at the End of 4 Months

  through study completion, an average of 4 months

Study Arms (1)

Treatment Group

EXPERIMENTAL

Drug: Isotretinoin

Interventions

Isotretinoin DRUG

Participants will be getting isotretinoin (1-1.5 mg/kg/week)

Treatment Group

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Samantha Karline

Charleston, South Carolina, 29403, United States

Location

Related Publications (15)

• Nagler AR, Milam EC, Orlow SJ. The use of oral antibiotics before isotretinoin therapy in patients with acne. J Am Acad Dermatol. 2016 Feb;74(2):273-9. doi: 10.1016/j.jaad.2015.09.046. Epub 2015 Oct 30.

  PMID: 26525749 BACKGROUND

• 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)

  BACKGROUND

• Dreno B, Thiboutot D, Gollnick H, Bettoli V, Kang S, Leyden JJ, Shalita A, Torres V; Global Alliance to Improve Outcomes in Acne. Antibiotic stewardship in dermatology: limiting antibiotic use in acne. Eur J Dermatol. 2014 May-Jun;24(3):330-4. doi: 10.1684/ejd.2014.2309.

  PMID: 24721547 BACKGROUND

• Bowe WP. Antibiotic resistance and acne: where we stand and what the future holds. J Drugs Dermatol. 2014 Jun;13(6):s66-70.

  PMID: 24918574 BACKGROUND

• Ross JI, Snelling AM, Carnegie E, Coates P, Cunliffe WJ, Bettoli V, Tosti G, Katsambas A, Galvan Perez Del Pulgar JI, Rollman O, Torok L, Eady EA, Cove JH. Antibiotic-resistant acne: lessons from Europe. Br J Dermatol. 2003 Mar;148(3):467-78. doi: 10.1046/j.1365-2133.2003.05067.x.

  PMID: 12653738 BACKGROUND

• Mandekou-Lefaki I, Delli F, Teknetzis A, Euthimiadou R, Karakatsanis G. Low-dose schema of isotretinoin in acne vulgaris. Int J Clin Pharmacol Res. 2003;23(2-3):41-6.

  PMID: 15018017 BACKGROUND

• Lee JW, Yoo KH, Park KY, Han TY, Li K, Seo SJ, Hong CK. Effectiveness of conventional, low-dose and intermittent oral isotretinoin in the treatment of acne: a randomized, controlled comparative study. Br J Dermatol. 2011 Jun;164(6):1369-75. doi: 10.1111/j.1365-2133.2010.10152.x. Epub 2011 May 17.

  PMID: 21114478 BACKGROUND

• Amichai B, Shemer A, Grunwald MH. Low-dose isotretinoin in the treatment of acne vulgaris. J Am Acad Dermatol. 2006 Apr;54(4):644-6. doi: 10.1016/j.jaad.2005.11.1061.

  PMID: 16546586 BACKGROUND

• Kotori MG. Low-dose Vitamin "A" Tablets-treatment of Acne Vulgaris. Med Arch. 2015 Feb;69(1):28-30. doi: 10.5455/medarh.2015.69.28-30. Epub 2015 Feb 21.

  PMID: 25870473 BACKGROUND

• Rademaker M, Wishart JM, Birchall NM. Isotretinoin 5 mg daily for low-grade adult acne vulgaris--a placebo-controlled, randomized double-blind study. J Eur Acad Dermatol Venereol. 2014 Jun;28(6):747-54. doi: 10.1111/jdv.12170. Epub 2013 Apr 26.

  PMID: 23617693 BACKGROUND

• Sardana K, Garg VK, Sehgal VN, Mahajan S, Bhushan P. Efficacy of fixed low-dose isotretinoin (20 mg, alternate days) with topical clindamycin gel in moderately severe acne vulgaris. J Eur Acad Dermatol Venereol. 2009 May;23(5):556-60. doi: 10.1111/j.1468-3083.2008.03022.x. Epub 2009 Jan 9.

  PMID: 19143903 BACKGROUND

• Akman A, Durusoy C, Senturk M, Koc CK, Soyturk D, Alpsoy E. Treatment of acne with intermittent and conventional isotretinoin: a randomized, controlled multicenter study. Arch Dermatol Res. 2007 Dec;299(10):467-73. doi: 10.1007/s00403-007-0777-2. Epub 2007 Aug 21.

  PMID: 17710426 BACKGROUND

• Goulden V, Clark SM, McGeown C, Cunliffe WJ. Treatment of acne with intermittent isotretinoin. Br J Dermatol. 1997 Jul;137(1):106-8.

  PMID: 9274635 BACKGROUND

• Kaymak Y, Ilter N. The effectiveness of intermittent isotretinoin treatment in mild or moderate acne. J Eur Acad Dermatol Venereol. 2006 Nov;20(10):1256-60. doi: 10.1111/j.1468-3083.2006.01784.x.

  PMID: 17062042 BACKGROUND

• Strauss JS, Rapini RP, Shalita AR, Konecky E, Pochi PE, Comite H, Exner JH. Isotretinoin therapy for acne: results of a multicenter dose-response study. J Am Acad Dermatol. 1984 Mar;10(3):490-6. doi: 10.1016/s0190-9622(84)80100-0.

  PMID: 6233335 BACKGROUND

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Isotretinoin

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors

Results Point of Contact

• Title: Dr. Samantha Karlin
• Organization: Medical University of South Carolina

karlin@musc.edu

(843)- 714-0146

Study Officials

• Samantha Karlin, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: The study member assessing change in acne using the Comprehensive Acne Severity Scale does not know the medication the participants are taking.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dermatology Resident Principal Investigator

Study Record Dates

• First Submitted: October 14, 2020
• First Posted: October 20, 2020
• Study Start: November 11, 2020
• Primary Completion: December 21, 2021
• Study Completion: December 21, 2021
• Last Updated: May 9, 2022
• Results First Posted: May 9, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: Immediately following publication, indefinitely

Locations

US (1)