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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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05316675
Enrollment
100
Registered
2022-04-07
Start date
2022-12-31
Completion date
2024-12-31
Last updated
2022-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne Vulgaris

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). .

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.

Interventions

DRUGIsotretinoin

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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
12 Years to 45 Years
Healthy volunteers
Yes

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 -

Design outcomes

Primary

MeasureTime frameDescription
To study the impact of different protocols of systemic isotretinoin in acne treatment on quality of life among egyptian patients using Cardiff Acne Disability Index6 monthsTo 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) .

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026