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NCT Number: NCT07771998

Dermal and Ophthalmological Acceptability Assessment in Sensitive Skin

This is a single-center, single-blind clinical study designed to evaluate the safety of the investigational product through dermatological and ophthalmological clinical assessments. A total of 33 female participants, aged 18 to 60 years, with a clinical diagnosis of sensitive skin confirmed by the Stinging Test, will be enrolled. Safety evaluations will be performed throughout the study period using standardized clinical assessments.

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Grupo Medcin

Osasco, São Paulo, 06023-070, Brazil

Location status: Recruiting

Location contact

Camila Canale

CONTACT

[email protected]

+55 (11) 98343 6952

Sergio Schalka

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female participants aged 18 to 60 years.
  • Participants with any skin type, with at least 25% representation of each skin type.
  • Participants with sensitive skin, clinically confirmed by the Stinging Test.
  • Intact skin in the assessment area.
  • Willingness to comply with all study procedures and attend scheduled visits and assessments.
  • Ability to understand, provide written informed consent, and sign the Informed Consent Form (ICF).

Exclusion criteria

  • Pregnant or breastfeeding women, or women at risk of becoming pregnant during the study.
  • Use of anti-inflammatory, immunosuppressive, or antihistamine medications within 3 weeks prior to screening.
  • Skin marks or conditions in the study area that may interfere with the evaluation of skin reactions, including vascular malformations, scars, excessive hair growth, multiple nevi, or sunburn.
  • History of atopic disease or allergy to cosmetic products.
  • Active skin diseases and/or lesions in the assessment area or elsewhere on the body.
  • Immunosuppression due to medication use or active disease.
  • Uncontrolled endocrine disorders.
  • Relevant medical history or current evidence of alcohol or drug abuse.
  • Known history or suspected intolerance to products of the same category as the investigational product.
  • Intense sun exposure within 15 days prior to assessment.
  • Aesthetic or dermatological treatments within 4 weeks prior to assessment.
  • Any other condition that, in the investigator's opinion, may justify exclusion from the study. Reasons for exclusion will be documented in the clinical record.
  • Participants with entropion, ectropion, hordeolum (stye), conjunctivitis, uveitis, or other active ocular diseases at screening.
  • Participants with corneal ulceration, blepharitis, meibomitis, pterygium, trichiasis, distichiasis, or other moderate to severe ocular disorders.
  • Initiation of contact lens use within 1 week prior to screening.
  • Use of ophthalmic products, including eye drops and/or ophthalmic ointments, within 3 weeks prior to screening.
  • Any other ocular condition that, in the investigator's opinion, may justify exclusion from the study. Reasons for exclusion will be documented in the clinical record.

Treatment and study plan

Blancy Pro

Other

Blancy Pro is a cosmetic product evaluated for safety and tolerability in female participants with clinically confirmed sensitive skin through dermatological and ophthalmological assessments.

Primary outcomes

  1. Dermatological and Ophthalmological Safety Assessment

    Time frame: Baseline (D0); D21

    Evaluation of the safety of the investigational product under real-world conditions of use by assessing the absence of dermatological and ophthalmological irritation and capturing participant-reported discomfort sensations in individuals with sensitive skin.

Study contacts

Contact information is provided by the study sponsor or research team.

Beatriz Santos Arnoni

CONTACT

[email protected]

+55 (11) 94742 3610

Sponsors and collaborators

Lead sponsor

Brainfarma Industria Química e Farmacêutica S/A

Industry

Registry information

Official study title

Evaluation of the Dermal and Ophthalmological Acceptability of Blancy Pro in Subjects With Sensitive Skin

Acronym: ADOPS

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 19, 2026
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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