Impact of Isotretinoin in Different Doses on Quality of Life

NCT ID: NCT05316675

Last Updated: 2022-04-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-31
• Study Completion Date: 2024-12-31

Brief Summary

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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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.

Conditions

Acne Vulgaris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group 1

:(25)patients will be treated by oral isotretinoin; 0.5 -1 mg/kg/day in two divided doses for 6 months.

Group Type: ACTIVE_COMPARATOR

Isotretinoin

Intervention Type: DRUG

isotretinoin 13-cis-retinoic acid), derived from vitamin A

Group 2

:(25) Patients will be treated by oral isotretinoin; 0.5 -1 mg/kg/day for seven days each month for 6 pulses.

Group Type: ACTIVE_COMPARATOR

Isotretinoin

Intervention Type: DRUG

isotretinoin 13-cis-retinoic acid), derived from vitamin A

Group 3

:(25) Patients will be treated by oral isotretinoin; 0.1-0.2 mg/kg/day for 6months

Group Type: ACTIVE_COMPARATOR

Isotretinoin

Intervention Type: DRUG

isotretinoin 13-cis-retinoic acid), derived from vitamin A

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

Group Type: ACTIVE_COMPARATOR

Isotretinoin

Intervention Type: DRUG

isotretinoin 13-cis-retinoic acid), derived from vitamin A

Interventions

Isotretinoin

isotretinoin 13-cis-retinoic acid), derived from vitamin A

Intervention Type: DRUG

Eligibility Criteria

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 -

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Asmaa Goda

principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

aila

Identifier Type: -

Identifier Source: org_study_id