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

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ClinicalTrials.gov Identifier: NCT02467101
Recruitment Status : Unknown
Verified May 2015 by Rubina Alves, Universitat Internacional de Catalunya.
Recruitment status was:  Not yet recruiting
First Posted : June 9, 2015
Last Update Posted : June 9, 2015
Sponsor:
Collaborator:
Universitat Internacional de Catalunya
Information provided by (Responsible Party):
Rubina Alves, Universitat Internacional de Catalunya

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.

Condition or disease Intervention/treatment Phase
Frontal Fibrosing Alopecia Other: Corticosteroid/Saline Not Applicable

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):

  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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective Double-blind, Placebo Controlled Study to Assess the Efficacy of Intralesional Corticoid on the Treatment of Frontal Fibrosing Alopecia
Study Start Date : July 2015
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015


Arm Intervention/treatment
Experimental: Corticosteroid/Saline

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).

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.

Other Names:
  • Frontal fibrosing alopecia
  • Cicatricial alopecia
  • Alopecia
  • Hair loss




Primary Outcome Measures :
  1. Phototricogram of two areas of the scalp [ Time Frame: 6 months ]
    Measuring hair count (number of hairs/0.65 cm2) by comparison with 6 months and baseline


Secondary Outcome Measures :
  1. Global photographs of the scalp [ Time Frame: 6 months ]
    The evaluation of hair growth will be assessed by comparison of standardized images between baseline and 6 months.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with the diagnosis of Frontal Fibrosing Alopecia

Exclusion Criteria:

  • Pregnancy
  • Patient unable to accomplishing all fases of treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02467101


Contacts
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Contact: Rubina Alves, M.D.. 00351913814831 rubinaalves@gmail.com

Locations
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Spain
Universitat Internacional Catalunya
Barcelona, Spain, 08195
Sponsors and Collaborators
Rubina Alves
Universitat Internacional de Catalunya
Investigators
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Principal Investigator: Rubina Alves, M.D. Universitat Internacional Catalunya
Principal Investigator: Juan Antonio Moreno, M.D. Universitat Internacional Catalunya
Study Director: Ramon Grimalt, M.D.; PhD Universitat Internacional Catalunya

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Responsible Party: Rubina Alves, Specialist Dermatology, M.D., Universitat Internacional de Catalunya
ClinicalTrials.gov Identifier: NCT02467101     History of Changes
Other Study ID Numbers: UIC-FFA
UICatalunya ( Registry Identifier: Rubina Alves )
First Posted: June 9, 2015    Key Record Dates
Last Update Posted: June 9, 2015
Last Verified: May 2015

Keywords provided by Rubina Alves, Universitat Internacional de Catalunya:
cicatricial alopecia
treatment
placebo
double-blind

Additional relevant MeSH terms:
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Hair Diseases
Alopecia
Alopecia Areata
Hypotrichosis
Skin Diseases
Pathological Conditions, Anatomical
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action