Formulation effect in patients with Alopecia Areata

Pilot study of the application of formulation containing Clobetasol Propionate Nanoparticles for the treatment of Alopecia Areata

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

REBEC

Registry ID

RBR-79z2sh

Enrollment

Unknown

Registered

2017-12-14

Start date

2017-11-01

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alopecia areata

Interventions

The intervention will be the topical application of nanoparticle formulation containing clobetasol propionate and comparison of its efficacy with the traditional clobetasol propionate cream formulatio

Drug

E02.319.300

Eligibility

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Male or female patients; aged between 18 and 65 years; confirmed clinical diagnosis of alopecia areata; Not responding to previous treatments for alopecia; Not being treated for alopecia for at least 6 months; Female pattern of alopecia with Ludwig grade II or higher; Absence of telogen effluvium in the last 6 months; Not allergic to any compound of the formulations

Exclusion criteria

Exclusion criteria: Hyper or hypothyroidism diagnosed during the study or decompensated; FAN greater than or equal to 1:320; Serum ferritin less than 40 ng/mL; Contraindications to the use of clobetasol propionate; Pre-treatment (within 6 months) with any of the active substances: Minoxidil hydrochloride and Finasteride.

Design outcomes

Primary

Measure	Time frame
Expected outcome: increase in capillary density. Pre- and post-intervention dermatoscopy will be performed and randomly numbered photos will be evaluated by at least three blind specialists. The SALT SCORE will be calculated before and after treatment, and the change from the overall A0 score (worsening or no improvement) to at least A1 (1-25% hair growth recovery) is considered a positive outcome.	—

Measure

Time frame

Expected outcome: increase in capillary density. Pre- and post-intervention dermatoscopy will be performed and randomly numbered photos will be evaluated by at least three blind specialists. The SALT SCORE will be calculated before and after treatment, and the change from the overall A0 score (worsening or no improvement) to at least A1 (1-25% hair growth recovery) is considered a positive outcome.

—

Secondary

Measure	Time frame
Expected outcome: perception of improvement among the research patients verified by interview at the end of the treatment. The patient will be questioned about the improvement in hair growth and improvement in quality of life, with a score from 1 to 5, being 4 and 5 indicative of a positive outcome.	—

Countries

Brazil

Contacts

Public ContactDr. Tais Gratieri

Laboratory of Food, Drug and Cosmetics (LTMAC)

tgratieri@gmail.com+55-61-31071842

Outcome results

None listed

Source: REBEC (via WHO ICTRP)