Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01111981
Other study ID # VDC2009O
Secondary ID
Status Recruiting
Phase Phase 4
First received April 26, 2010
Last updated April 27, 2010
Start date October 2009
Est. completion date October 2010

Study information

Verified date April 2010
Source Callender Center for Clinical Research
Contact Lynn Carter, BA
Phone 301-249-0970
Email clinresearch@callenderskin.com
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to ascertain the safety and efficacy of

Clobetasol Propionate 0.05% E Foam in the treatment of Central Centrifugal

Cicatricial Alopecia.


Description:

Central Centrifugal Cicatricial Alopecia (CCCA) is an inflammation-induced

hair loss starting in the central scalp and progressing centrifugally. The

cause of CCCA is unknown. Early diagnosis and treatment is essential to stop

or slow the progression of scarring and permanent hair loss. Once scarring

occurs, the hair follicles are obliterated and the hair cannot regrow. Thus,

anti-inflammatory medications are used to decrease inflammation. Current

treatment includes topical and intralesional corticosteroids, oral

antibiotics, and hair transplantation, all which may take months to years to

show improvement. There is no evidence-based medicine on how to treat

primary cicatricial alopecias. Clobestasol Propionate 0.05% Emollient Foam is

an FDA-approved and marketed topical corticosteroid for the treatment of the

inflammatory and pruritic manifestations of moderate to severe corticosteroid-

responsive dermatoses of the scalp. Many studies found the foam to be less

irritating than the original formulation.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date October 2010
Est. primary completion date February 2010
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Patients with CCCA, treated or untreated

- Score 0 - 1 on Scale/Questionnaire

- 18 years of age or older

- Women of African descent

Exclusion Criteria:

- Score > 1 on Scale/Questionnaire

- Alopecias other than CCCA, including alopecia arreata, lichen planopilaris, trichotillomania, and traction alopecia

- History of hair transplantation

- Children less than 18 years of age

- Males

- Women of non-African descent

- Pregnancy or breastfeeding. Women of childbearing age must use reliable forms of contraception (e.g., abstinence, oral contraceptives, or spermicide and condoms)

- Anti-dandruff shampoo within 30 days

- Anti-inflammatory medications such as antibiotics (doxycycline, minocycline, rifampin, etc.), steroids (oral prednisone, topical corticosteroids,etc.), NSAIDs (ibuprofen, aspirin, etc.)

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Clobetasol Propionate 0.05% Emollient Foam
Clobetasol Propionate 0.05% E Foam to be applied to affected area once a day for 16 weeks

Locations

Country Name City State
United States Callender Center for Clinical Research Mitchellville Maryland

Sponsors (1)

Lead Sponsor Collaborator
Callender Center for Clinical Research

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Improvement of pruritis, tenderness, and pain 4 months Yes
Secondary Absence of inflammation on biopsy 4 months Yes
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04953416 - Fractional Non-ablative Laser for the Treatment of Hair Loss N/A
Completed NCT01929330 - Bioequivalence Study of Dutasteride Five 0.1 mg and One 0.5 mg Soft Gelatin Capsules in Healthy Male Volunteers Phase 1
Recruiting NCT05213936 - Scalp Cooling for Chemotherapy-Induced Alopecia in Patients of Color N/A
Completed NCT02919735 - Efficacy, Safety and Tolerability of CG428 Cutaneous Solution on Chemotherapy Induced Alopecia; Controlled Study (ELAN) Phase 2
Recruiting NCT02591823 - Hair Fall in Patients on Low Dose Methotrexate N/A
Enrolling by invitation NCT01651689 - Hair Counts From Vertical and Horizontal Sections of Scalp Biopsy SPecimens in Thai Population With Alopecia N/A
Completed NCT01189279 - Safety and Pharmacokinetics Study of New Formulation of Bimatoprost in Patients With Alopecia Phase 1
Terminated NCT01385839 - Efficacy of Hair Transplantation Compared With Hypodermic Needle Irritation in Alopecia Areata N/A
Active, not recruiting NCT03382184 - Fractional Photothermolysis for Hair Follicle Induction Early Phase 1
Not yet recruiting NCT05544448 - In Vitro Effect Study of Interleukin-2 Muteins on Regulatory T Cells of Patients With Different Autoimmune, Allo-immune or Inflammatory Diseases N/A
Completed NCT03689452 - The Effect of Platelet Rich Plasma on Non-scarring Alopecia N/A
Completed NCT06409650 - To Evaluate Safety and Efficacy of KX-826 in Chinese Female Subjects With Androgenetic Alopecia Phase 2
Recruiting NCT00801086 - Efficacy Study of Tempol to Prevent Hair Loss From Radiotherapy to the Brain Phase 2
Completed NCT06095739 - Study to Investigate the Effectiveness of a Topical Cosmetic Formulation DA-OTC-002 N/A
Completed NCT05587699 - The Parallel Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of CKD-843 A Phase 1
Completed NCT03351322 - ENERGI-F701 for Female Hair Loss Treatment Phase 2
Terminated NCT02935569 - Compression Headband Use to Prevent Hair Loss During Whole Brain Radiotherapy N/A
Not yet recruiting NCT01557491 - Hair Regrowth After Bicoronal Incision N/A
Completed NCT01590238 - Enhancing Hair Density With Platelet Rich Fibrin Matrix (PRFM) Phase 3
Completed NCT00515762 - Prevention of Persistent Alopecia Following Docetaxel by Means of Scalp Cooling Phase 2