Effects of Naltrexon in patients with Frontal Fibrosing Alopecia

Clinical comparison between oral low dose of Naltrexon and standard medication in patients with Frontal Fibrosing Alopecia

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230326057776N1

Enrollment

Registered

2023-04-01

Start date

2023-04-21

Completion date

Unknown

Last updated

2023-04-03

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

Conditions

Frontal Fibrosing Alopecia. Cicatricial alopecia, unspecified

Interventions

Intervention 1: Intervention group: Naltrexon. Intervention 2: Intervention group: Standard medication.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: New patients without any other medications Active status of illness after leaving a systemic medication (at least a month) Active status of illness while the participants are using a topical medication

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Pre-follicular scale. Timepoint: Examinations is done at the beginning of the study and then 2, 4 and 6 months later. Method of measurement: Using Dermoscope.;Erythema. Timepoint: Examinations is done at the beginning of the study and then 2, 4 and 6 months later. Method of measurement: Observiation.;Interfollicular scale. Timepoint: Examinations is done at the beginning of the study and then 2, 4 and 6 months later. Method of measurement: Using a dermoscope.;Decline in frontal and temple hair line. Timepoint: Examinations is done at the beginning of the study and then 2, 4 and 6 months later. Method of measurement: Using a ruler.	—

Measure

Time frame

Pre-follicular scale. Timepoint: Examinations is done at the beginning of the study and then 2, 4 and 6 months later. Method of measurement: Using Dermoscope.;Erythema. Timepoint: Examinations is done at the beginning of the study and then 2, 4 and 6 months later. Method of measurement: Observiation.;Interfollicular scale. Timepoint: Examinations is done at the beginning of the study and then 2, 4 and 6 months later. Method of measurement: Using a dermoscope.;Decline in frontal and temple hair line. Timepoint: Examinations is done at the beginning of the study and then 2, 4 and 6 months later. Method of measurement: Using a ruler.

—

Secondary

Measure	Time frame
Ceasing the progression of disease. Timepoint: Examination is done at the beginning of the study and then 2, 4 and 6 months later. Method of measurement: Frontal Fibrosing Alopecia Severity Index (FFASI).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFatemeh Azadmanesh

Esfahan University of Medical Sciences

fatemehazadmanesh95@gmail.com009831202020

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026