Impact of Isotretinoin in Different Doses on Quality of Life

Impact of Different Protocols of Systemic Isotretinoin in Acne Treatment on Quality of Life Among Egyptien Patients:Avalidity and Reliability Study

The Cardiff Acne Disability Index is a short five-item questionnaire derived from the longer Acne Disability Index.It is designed for use in teenagers and young adults with acne. It is self explanatory and can be simply handed to the patient who is asked to complete it without the need for detailed explanation( .Abdelrazik etal., 2021).

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Study Overview

• Status: Not yet recruiting
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: Isotretinoin

Detailed Description

Lower doses of isotretinoin can be effective in terms of cost and decreasing systemic side effects. Therefore, other regimens may be used instead of daily conventional dose as alternate, pulse and low doses of oral isotretinoin in acne vulgaris( Agarwal et al., 2011).

To study the impact of different protocols of systemic isotretinoin in acne treatment on quality of life among egyptian patients using Cardiff Acne Disability Index (CADI) and dermatology life quality index (DLQI)questionnaires.

To assess validity and reliability of the translated Arabic version of CADI. To compare the clinical efficacy and tolerability of different protocols of systemic isotretinoin in acne treatment.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Patients with clinically diagnosed acne vulgaris older than 18 years of age

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Exclusion Criteria:

Patients having personal or family history of hyperlipidemia. Pregnancy and lactation. Newly married female desiring to get pregnant or using temporary method of contraception.

Patients with a history suggestive of any psychic disturbance -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1; :(25)patients will be treated by oral isotretinoin; 0.5 -1 mg/kg/day in two divided doses for 6 months.	Drug: Isotretinoin; isotretinoin 13-cis-retinoic acid), derived from vitamin A
Active Comparator: Group 2; :(25) Patients will be treated by oral isotretinoin; 0.5 -1 mg/kg/day for seven days each month for 6 pulses.	Drug: Isotretinoin; isotretinoin 13-cis-retinoic acid), derived from vitamin A
Active Comparator: Group 3; :(25) Patients will be treated by oral isotretinoin; 0.1-0.2 mg/kg/day for 6months	Drug: Isotretinoin; isotretinoin 13-cis-retinoic acid), derived from vitamin A
Active Comparator: Group 4: (25) Patients will be treated by oral isotretinoin;20mg /day for one month then the dose increased in monthly steps to reach the standard dosing for 6 months	Drug: Isotretinoin; isotretinoin 13-cis-retinoic acid), derived from vitamin A

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To study the impact of different protocols of systemic isotretinoin in acne treatment on quality of life among egyptian patients using Cardiff Acne Disability Index	To assess validity and reliability of the translated Arabic version of CADI.CADI is a tool to assess the effect of acne on quality of life with a possible maximum score of 15 and a minimum of 0. (grade of impairment; 0 no impairment, 1-5 mild impairment, 6-10 moderate impairment, and 11-15 severe impairment).The Cardiff Acne Disability Index (CADI) is a short five-item questionnaire derived from the longer Acne Disability Index. CADI is designed for use in teenagers and young adults with acne. It is self explanatory and can be simply handed to the patient who is asked to complete it without the need for detailed explanation (Abdelrazik etal., 2021).the higher the score, the more the quality of life is impaired. The CADI is usually completed in one minute (Motley and Finlay,1992) .	6 months

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2022
• Primary Completion (Anticipated): October 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: March 19, 2022
• First Submitted That Met QC Criteria: March 30, 2022
• First Posted (Actual): April 7, 2022

Study Record Updates

• Last Update Posted (Actual): April 7, 2022
• Last Update Submitted That Met QC Criteria: March 30, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Dermatologic Agents; Isotretinoin
• Other Study ID Numbers: aila

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No