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

Primary Purpose

Frontal Fibrosing Alopecia

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Corticosteroid/Saline
Sponsored by
Rubina Alves
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Frontal Fibrosing Alopecia focused on measuring cicatricial alopecia, treatment, placebo, double-blind

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with the diagnosis of Frontal Fibrosing Alopecia

Exclusion Criteria:

  • Pregnancy
  • Patient unable to accomplishing all fases of treatment

Sites / Locations

  • Universitat Internacional Catalunya

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Corticosteroid/Saline

Arm Description

Corticosteroid/Saline Patients with diagnosis of frontal fibrosing alopecia are included in the study. The diagnosis is based on the clinical findings of frontal and temporoparietal hairline recession with loss of follicular ostia. In the same patient, intralesional triamcinolone acetone will be injected to half-head (in the active border of hairline) and in the other half-head the patient will be injected with saline solution (placebo). The intralesional triamcinolone acetone (40 mg/ml)l) of 0,1 mL/1cm, is given along the frontal and frontoparietal hairline every 4 weeks (3 sessions). This study includes 4 visits: 3 visits of treatment (with 1-month interval) and 1 visit of follow-up (month 6).

Outcomes

Primary Outcome Measures

Phototricogram of two areas of the scalp
Measuring hair count (number of hairs/0.65 cm2) by comparison with 6 months and baseline

Secondary Outcome Measures

Global photographs of the scalp
The evaluation of hair growth will be assessed by comparison of standardized images between baseline and 6 months.

Full Information

First Posted
May 27, 2015
Last Updated
June 4, 2015
Sponsor
Rubina Alves
Collaborators
Universitat Internacional de Catalunya
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1. Study Identification

Unique Protocol Identification Number
NCT02467101
Brief Title
Study to Assess the Efficacy of Intralesional Corticosteroid on the Treatment of Frontal Fibrosing Alopecia
Acronym
FFA
Official Title
Prospective Double-blind, Placebo Controlled Study to Assess the Efficacy of Intralesional Corticoid on the Treatment of Frontal Fibrosing Alopecia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Rubina Alves
Collaborators
Universitat Internacional de Catalunya

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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): 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) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frontal Fibrosing Alopecia
Keywords
cicatricial alopecia, treatment, placebo, double-blind

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Corticosteroid/Saline
Arm Type
Experimental
Arm Description
Corticosteroid/Saline Patients with diagnosis of frontal fibrosing alopecia are included in the study. The diagnosis is based on the clinical findings of frontal and temporoparietal hairline recession with loss of follicular ostia. In the same patient, intralesional triamcinolone acetone will be injected to half-head (in the active border of hairline) and in the other half-head the patient will be injected with saline solution (placebo). The intralesional triamcinolone acetone (40 mg/ml)l) of 0,1 mL/1cm, is given along the frontal and frontoparietal hairline every 4 weeks (3 sessions). This study includes 4 visits: 3 visits of treatment (with 1-month interval) and 1 visit of follow-up (month 6).
Intervention Type
Other
Intervention Name(s)
Corticosteroid/Saline
Other Intervention Name(s)
Frontal fibrosing alopecia, Cicatricial alopecia, Alopecia, Hair loss
Intervention Description
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.
Primary Outcome Measure Information:
Title
Phototricogram of two areas of the scalp
Description
Measuring hair count (number of hairs/0.65 cm2) by comparison with 6 months and baseline
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Global photographs of the scalp
Description
The evaluation of hair growth will be assessed by comparison of standardized images between baseline and 6 months.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with the diagnosis of Frontal Fibrosing Alopecia Exclusion Criteria: Pregnancy Patient unable to accomplishing all fases of treatment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rubina Alves, M.D..
Phone
00351913814831
Email
rubinaalves@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rubina Alves, M.D.
Organizational Affiliation
Universitat Internacional Catalunya
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Juan Antonio Moreno, M.D.
Organizational Affiliation
Universitat Internacional Catalunya
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ramon Grimalt, M.D.; PhD
Organizational Affiliation
Universitat Internacional Catalunya
Official's Role
Study Director
Facility Information:
Facility Name
Universitat Internacional Catalunya
City
Barcelona
ZIP/Postal Code
08195
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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