Study to Assess the Efficacy of Intralesional Corticosteroid on the Treatment of Frontal Fibrosing Alopecia

Frontal Fibrosing Alopecia Clinical Trial

— FFA  

Official title:

Prospective Double-blind, Placebo Controlled Study to Assess the Efficacy of Intralesional Corticoid on the Treatment of Frontal Fibrosing Alopecia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02467101
• Other study ID #: UIC-FFA
• Secondary ID: UICatalunya
• Status: Not yet recruiting
• Phase: N/A
• First received: May 27, 2015
• Last updated: June 4, 2015
• Start date: July 2015
• Est. completion date: December 2015

Study information

• Verified date: May 2015
• Source: Universitat Internacional de Catalunya
• Contact: Rubina Alves, M.D..
• Phone: 00351913814831
• Email: rubinaalves[@]gmail.com
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the efficacy of treatment with intralesional injection of corticosteroids on the treatment of Frontal Fibrosing Alopecia (compared with placebo), between three months, six months and baseline.

Description:

Frontal fibrosing alopecia (FFA) is a primary lymphocytic cicatricial alopecia, that was first described in postmenopausal women, by Kossard in 1994. Since then, FFA has also been reported in premenopausal women and rarely in men.

The exact cause of FFA is unknown. One possible reason can be the disturbed immune response to some component of the scalp hair follicles, however, whether or not the hair loss is caused by hormonal fluctuations is under question. Some authors, consider that FFA is a variant of liquen planopilaris (LPP). Whether FFA is truly an LPP variant or is a distinct entity with shared clinical features remains to be determined. FFA was also diagnosed in family members (mother and daughter) suggesting a possible genetic contribution.

Clinically, it is characterized by progressive frontal and temporoparietal recession of the hairline due to inflammatory destruction of hair follicles. Hair loss occurs in a band-like distribution and the depth of recession can be from 0,5-8 cm. Often, a small number of isolated hairs are spared within the band of alopecia.

Loss of eyebrows (partial or complete) is a finding in FFA and in some cases, can precede the hairline recession. The affected skin is atrophic, shiny, and often lighter than the chronically sun-exposed forehead skin.

The diagnosis of FFA is usually made on the basis of clinical findings, and laboratory tests are rarely required. Dermoscopy, a noninvasive tool can help for the diagnosis of FFA; The dermoscopic features of FFA are: Absence of follicular openings, perifollicular scale, and a feeble perifollicular erythema. Perifollicular erythema at the receding hairline may be a sign of active disease.

Since the first description of FFA, many reports have been published, and the number of new cases of FFA appears to be increasing.

Currently, there are no evidence-based studies to guide treatment and there is no clearly defined line of treatment for the condition. Therefore treatment options vary among clinicians.

The aim of this study is to find if intralesional triamcinolone acetonide (compared to area treated with placebo) may help to halt or slow down the progression of this disease.

The patients are divided into two groups (A and B):

1. Group A: right half-head (active border of the disease): treatment with intralesional triamcinolone acetonide left half-head (active border of the disease): placebo (saline solution)

2. Group B: right half-head (active border of the disease):placebo (saline solution)

left half-head (active border of the disease): intralesional triamcinolone acetonide

The aim of this study is to find if intralesional triamcinolone may help to halt or slow down the progres- sion of this disease.

All patients provide written informed consent before participating in the study, which is performed according to the Declaration of Helsinki.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients with the diagnosis of Frontal Fibrosing Alopecia

Exclusion Criteria:

• Pregnancy

• Patient unable to accomplishing all fases of treatment

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Frontal Fibrosing Alopecia

Intervention

Other:
• Corticosteroid/Saline
Corticosteroid/Saline Two groups were defined: group A and group B. Group A receives treatment with intralesional triamcinolone acetonide on the right half-head and placebo on the left half-head Group B receives administration of intralesional triamcinolone acetonide on left half-head and placebo on the right half-head. Same patient will be injected with intralesional triamcinolone acetonide and a saline solution. Each patient will be injected on half-head.

Locations

Country	Name	City	State
Spain	Universitat Internacional Catalunya	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Rubina Alves	Universitat Internacional de Catalunya

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phototricogram of two areas of the scalp	Measuring hair count (number of hairs/0.65 cm2) by comparison with 6 months and baseline	6 months	Yes
Secondary	Global photographs of the scalp	The evaluation of hair growth will be assessed by comparison of standardized images between baseline and 6 months.	6 months	Yes