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

NCT02467101 | Unknown

• 2 other identifiers: UIC-FFAUICatalunya
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Frontal Fibrosing Alopecia

Keywords

cicatricial alopecia; treatment; placebo; double-blind

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Global photographs of the scalp

  6 months

Study Arms (1)

Corticosteroid/Saline

EXPERIMENTAL

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

Interventions

Corticosteroid/Saline OTHER

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

Corticosteroid/Saline

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with the diagnosis of Frontal Fibrosing Alopecia

You may not qualify if:

• Pregnancy
• Patient unable to accomplishing all fases of treatment

Sponsors & Collaborators

• Rubina Alves: lead
• Universitat Internacional de Catalunya: collaborator

Study Sites (1)

Universitat Internacional Catalunya

Barcelona, Barcelona, 08195, Spain

Location

MeSH Terms

Conditions

Alopecia

Interventions

Adrenal Cortex Hormones; Sodium Chloride

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Rubina Alves, M.D.

  Universitat Internacional Catalunya

  PRINCIPAL INVESTIGATOR

• Juan Antonio Moreno, M.D.

  Universitat Internacional Catalunya

  PRINCIPAL INVESTIGATOR

• Ramon Grimalt, M.D.; PhD

  Universitat Internacional Catalunya

  STUDY DIRECTOR

Central Study Contacts

Rubina Alves, M.D..

CONTACT

00351913814831; rubinaalves@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Specialist Dermatology, M.D.

Study Record Dates

• First Submitted: May 27, 2015
• First Posted: June 9, 2015
• Study Start: July 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: June 9, 2015

Record last verified: 2015-05

Locations

ES (1)