NCT05839223

Brief Summary

The objective of the study was to evaluate the role of clinical pharmacists in improving adherence to medication and the recommendations related to isotretinoin, awareness about proper use, dealing with the side effects, and anxiety and depressive symptoms. Patients were randomly assigned to an intervention group (received the educational process (recommendations) about isotretinoin by a clinical pharmacist in addition to the routine education about isotretinoin provided by the physician) and a control group (received only the routine education about isotretinoin provided by the physician) and then followed for three months. Patient's adherence to the recommendations, patient's knowledge about isotretinoin, and side effects management for both groups were measured through a set of questions adapted from a validated questionnaire at baseline and after three months. Adherence scale was used to evaluate adherence to the medication after three months. Hospital Anxiety and Depression Scale were used to assess depressive and anxiety symptoms at baseline and at follow-up in each group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
207

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2021

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2021

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

March 12, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 3, 2023

Completed
Last Updated

May 3, 2023

Status Verified

April 1, 2023

Enrollment Period

6 months

First QC Date

March 12, 2023

Last Update Submit

April 20, 2023

Conditions

Acne Vulgaris

Keywords

Isotretinoin, Clinical Pharmacist, Counseling, Adherence

Outcome Measures

Primary Outcomes (2)

  • Knowledge

    The patient knowledge section consisted of ten different questions/items, and each item had two answers (yes/no). Items were coded according to the answer; the correct (adequate) answer was coded as one (1), while the wrong (not adequate) answer was coded as zero (0). So, the knowledge score could take the values of 0 (no knowledge) to 10 (perfect knowledge).

    3 months

  • Adherence to the Recommendations

    10 items for all patients, and each item had answers (yes/no). Items were coded according to the answer; the correct (adherent) answer was coded as one (1), while the wrong (not adherent) answer was coded as zero (0). The adherence score of patients 'compliance with the recommendations ranged between 0 (least adherent) to 10 (most adherent).

    3 months

Secondary Outcomes (1)

  • HADS

    3 MONTHS

Study Arms (2)

Intervention

EXPERIMENTAL

received the educational process (recommendations) about isotretinoin by a clinical pharmacist in addition to the routine education about isotretinoin provided by the physician

Other: Education

Control

NO INTERVENTION

received only the routine education about isotretinoin provided by the physician

Interventions

EducationOTHER

educational process (recommendations) about isotretinoin by a clinical pharmacist. The information included: the degree of the importance of adherence to the drug and the recommendations, the correct method of taking it, the importance of doing periodic laboratory tests (lipid profile, liver enzyme test, and pregnancy test), common side effects, how to properly avoid and deal with side effects, precaution warnings they should pay attention to, and what are the cases in which the drug should be stopped.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female patients aged 18 years or older who were using isotretinoin.
  • Patients with a current diagnosis of moderate to severe acne vulgaris.
  • Patients who were on or going to receive standard isotretinoin doses (0.5-1mg/kg/day).
  • Patients who were willing to participate in the study and to do a follow-up.

You may not qualify if:

  • Pregnant women and women who intend to become pregnant.
  • Breastfeeding women.
  • Presence of any renal or hepatic compromise or any pre-existing hyperlipidemia.
  • Patients who were not willing to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Abdullah University Hospital

Irbid, Select Region, 22110, Jordan

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 12, 2023

First Posted

May 3, 2023

Study Start

September 1, 2020

Primary Completion

February 15, 2021

Study Completion

February 20, 2021

Last Updated

May 3, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

JO(1)