An interventional study of Corticosteroid/Saline in Frontal Fibrosing Alopecia, sponsored by Rubina Alves. Status unknown at 1 site in Spain. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-06-09.
Sponsored by Rubina Alves · Not applicable, Interventional, and Treatment
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.
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):
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.
607 studies on the registry are indexed under Alopecia; 129 are open to participants now.
This study's planned enrollment of 10 is below the median of 45 across 512 interventional studies indexed under Alopecia.
Browse Alopecia studies →This is the only study on the registry with Rubina Alves as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Also known as: Frontal fibrosing alopecia, Cicatricial alopecia, Alopecia, Hair loss
Phototricogram of two areas of the scalp
Measuring hair count (number of hairs/0.65 cm2) by comparison with 6 months and baseline
Time frame: 6 months
Global photographs of the scalp
The evaluation of hair growth will be assessed by comparison of standardized images between baseline and 6 months.
Time frame: 6 months
This study is status unknown, as verified in May 2015. You cannot join it, but the record below documents what was studied.
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