Impact of Isotretinoin in Different Doses on Quality of Life

NCT05316675 | Unknown Phase 4

• 1 other identifier: aila
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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). .

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Group 1

ACTIVE COMPARATOR

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

Drug: Isotretinoin

Group 2

ACTIVE COMPARATOR

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

Drug: Isotretinoin

Group 3

ACTIVE COMPARATOR

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

Drug: Isotretinoin

Group 4:

ACTIVE COMPARATOR

(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

Interventions

Isotretinoin DRUG

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

Group 1; Group 2; Group 3; Group 4:

Eligibility Criteria

• Age: 12 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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 -

Sponsors & Collaborators

• Assiut University: lead

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: March 19, 2022
• First Posted: April 7, 2022
• Study Start: December 1, 2022
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 7, 2022

Record last verified: 2022-03