Development of Retinoic Acid Formulation for Acne

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

REBEC

Registry ID

RBR-3t5ts4

Enrollment

Unknown

Registered

2020-09-16

Start date

2018-09-03

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

Disorders of skin appendages

Interventions

The volunteers will be separated into 12 different groups, with 40 individuals each group, being: 1- Women, phototype I, 2- Women, phototype II, 3- Women, phototype III, 4- Women, phototype IV, 5- Wom

Drug

E02.319.267.120.060

Eligibility

Age

18 Years to 35 Years

Inclusion criteria

Inclusion criteria: Healthy volunteers; both genders; age between 18 and 35 years

Exclusion criteria

Exclusion criteria: Present hypersensitivity to any of the components of the formulation; pregnant women; lactating; have skin burns, eczema or any other chronic skin disease; atopic individuals; present any metabolic disease; have any autoimmune disease; having had a vaccine up to two weeks before the start of the study or having the intention to have a vaccine while the study was being conducted; having already undergone chemotherapy treatment or being undergoing this type of treatment; making use of corticosteroid medications; make use of potentially photosensitizing drugs, such as thiazides, tetracyclines, fluoroquinolones, phenothiazines and sulfonamides during the conduct of the experiment; individuals who are exposed to the intense sun frequently or who have been exposed to the intense sun in the last four months; individuals whose forearm skin has undergone procedures such as hair removal, chemical peels, dermabrasion or laser resurfacing.

Design outcomes

Primary

Measure	Time frame
Decrease in skin toxicity promoted by topical application of retinoic acid carried in formulations of nanostructured lipid carriers (NLC) and solid lipid nanoparticles (SLN) when compared to the conventional formulation of commercially available retinoic acid (Vitanol®, Stiefel), verified by the reduction of transepidermal water loss, based on a statistically significant finding with a 95% confidence interval.	—

Measure

Time frame

Decrease in skin toxicity promoted by topical application of retinoic acid carried in formulations of nanostructured lipid carriers (NLC) and solid lipid nanoparticles (SLN) when compared to the conventional formulation of commercially available retinoic acid (Vitanol®, Stiefel), verified by the reduction of transepidermal water loss, based on a statistically significant finding with a 95% confidence interval.

—

Secondary

Measure	Time frame
Secondary outcomes are not expected	—

Countries

Brazil

Contacts

Public ContactFlávia;Gisele Lima;Goulart

Faculdade de Farmácia da Universidade Federal de Minas Gerais;Faculdade de Farmácia da Universidade Federal de Minas Gerais

flavialima09@gmail.com;giseleacgoulart@gmail.com+55-31-987588527;+55-31-34096993

Outcome results

None listed

Source: REBEC (via WHO ICTRP)