Impact of Isotretinoin in Different Doses on Quality of Life

Assiut University

Status and phase: Not yet enrolling; Phase 4

Conditions: Acne Vulgaris

Treatments: Drug: Isotretinoin

Study type: Interventional

Funder types: Other

Identifiers

NCT05316675

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Details and patient eligibility

About

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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Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 12 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

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 -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 4 patient groups

Group 1

Active Comparator group

Description:

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

Treatment:

Drug: Isotretinoin

Group 2

Active Comparator group

Description:

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

Treatment:

Drug: Isotretinoin

Group 3

Active Comparator group

Description:

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

Treatment:

Drug: Isotretinoin

Group 4:

Active Comparator group

Description:

(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

Treatment:

Drug: Isotretinoin