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NCT Number: NCT07797192

Evaluation of Allergenicity by HRIPT and Phototest

This clinical study will evaluate the dermatological safety and allergenic potential of a cosmetic product. The study will use the Human Repeat Insult Patch Test (HRIPT) and phototest procedures to assess whether the product may cause skin irritation, allergic reactions, photoirritation, or photosensitization after repeated use and exposure to ultraviolet light.

Participants will receive applications of the investigational product under controlled conditions and will undergo dermatological evaluations throughout the study. The results will help determine the product's skin compatibility and safety for consumer use.

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Key information

Conditions

Safety

Age range

18 year–70 year

Sex eligibility

All sexes

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

About this study

This is a single-center, single-blind, non-comparative clinical study designed to evaluate the dermal compatibility and allergenic potential of an investigational cosmetic product using the Human Repeat Insult Patch Test (HRIPT) and phototest procedures.

The HRIPT phase will assess primary dermal irritation, cumulative irritation, and skin sensitization potential through repeated applications of patches containing the investigational product to the participants' backs under maximized conditions. The practical phase lasts six weeks and includes three weeks of product application, two weeks of rest, and one challenge week with product reapplication on a previously untreated skin site.

The phototest phase will assess the photoirritant and photosensitizing potential of the investigational product following controlled exposure to ultraviolet radiation. Product-containing patches will be applied to the skin and, after removal, the test sites will undergo controlled ultraviolet irradiation. The practical phase lasts five weeks and includes induction, rest, and challenge phases.

Dermatological evaluations will be performed according to standardized criteria, including assessments based on the International Contact Dermatitis Research Group (ICDRG) scale, to confirm the absence of clinically significant irritant, allergenic, photoirritant, or photosensitizing reactions.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male and female participants aged 18 to 70 years.
  • Fitzpatrick skin phototypes I, II, III, or IV.
  • Intact skin at the application site.
  • Willingness to comply with all study procedures and attend scheduled clinic visits for medical assessments, patch applications, and patch readings.
  • Ability to understand the study requirements, provide written informed consent, and sign the Informed Consent Form (ICF).

For the phototest procedure, only participants with Fitzpatrick skin phototypes II and III will be eligible.

Exclusion criteria

  • Pregnant or breastfeeding women, or women at risk of becoming pregnant during the study.
  • Use of anti-inflammatory medications within 30 days prior to screening or immunosuppressive medications within 3 months prior to screening.
  • Immunosuppression due to medication use or active disease.
  • Uncontrolled endocrine disorders.
  • Personal history of atopy.
  • Intense sun exposure or tanning sessions within 15 days prior to assessment or during the study period.
  • Planned intense sun exposure or tanning sessions during the study period.
  • Planned sea bathing, swimming pool use, or sauna sessions during the study period.
  • Participation in water sports during the study period.
  • Dermographism.
  • Use of oral or topical vitamin A acid (retinoids) or related derivatives within 1 week prior to study initiation.
  • Aesthetic and/or dermatological body treatments within 3 weeks prior to screening.
  • Scheduled vaccination during the study period or within 3 weeks prior to screening.
  • History of sensitization, irritation, or photosensitization to topical products.
  • Active local or generalized skin diseases that may interfere with study assessments.
  • Skin hyperreactivity.
  • Initiation of new medications during the study period.
  • Previous participation in studies involving the same investigational product.
  • Congenital or acquired immunodeficiency.
  • Relevant medical history or current evidence of alcohol or substance abuse.
  • Known or suspected intolerance to any ingredient contained in the investigational or comparator products.
  • History of poor compliance or unwillingness to comply with the study protocol.
  • Employees of the study site, sponsor, or their immediate family members directly involved in the study.
  • Any other condition that, in the investigator's opinion, may interfere with study participation or justify exclusion from the study.

Additional Exclusion Criteria for the Phototest:

  • History of diseases aggravated or triggered by ultraviolet radiation.
  • Use of photosensitizing medications.
  • History or current presence of photodermatoses.
  • Personal or family history of skin cancer.
  • Presence of precancerous skin lesions, including melanocytic nevi or actinic keratoses, that may interfere with study assessments.

Treatment and study plan

Blancy Pro

Other

Blancy Pro is a cosmetic product evaluated for dermatological safety, skin sensitization, photoirritation, and photosensitization potential. Participants will undergo Human Repeat Insult Patch Test (HRIPT) and phototest procedures involving repeated applications of the product under controlled conditions, followed by dermatological assessments to evaluate skin compatibility and the absence of allergenic reactions.

Primary outcomes

  1. Dermal Irritation Assessed by Human Repeat Insult Patch Test (HRIPT) Using ICDRG Criteria

    Time frame: Day 3 and Day 5

    Dermal irritation following application of Blancy Pro will be assessed using the Human Repeat Insult Patch Test (HRIPT). Patches containing the investigational product and control patches (saline solution, mineral oil, patch without product, and adhesive tape control) will be applied to the lateral back. Skin reactions will be evaluated 48 hours (Day 3) and 96 hours (Day 5) after application according to the International Contact Dermatitis Research Group (ICDRG) grading scale. Skin reactions will be graded according to the International Contact Dermatitis Research Group (ICDRG) criteria, ranging from 0 (negative reaction) to 4 (strong positive reaction). Higher grades indicate greater skin reactivity.

  2. Cumulative Dermal Irritation Assessed by Human Repeat Insult Patch Test (HRIPT) Using ICDRG Criteria

    Time frame: Day 3, Day 5, Day 8, Day 10, Day 12, Day 15, Day 17, and Day 19

    Cumulative dermal irritation following repeated applications of Blancy Pro will be assessed using the Human Repeat Insult Patch Test (HRIPT). Patches containing the investigational product and control materials will be repeatedly applied to the lateral back over a 3-week induction period. Skin reactions will be evaluated 15 to 30 minutes after patch removal and graded according to the International Contact Dermatitis Research Group (ICDRG) criteria. Skin reactions will be graded according to the International Contact Dermatitis Research Group (ICDRG) criteria, ranging from 0 (negative reaction) to 4 (strong positive reaction). Higher grades indicate greater skin reactivity.

  3. Dermal Sensitization Assessed by Human Repeat Insult Patch Test (HRIPT) Challenge Phase Using ICDRG Criteria

    Time frame: Day 38 and Day 39

    Dermal sensitization following repeated application of Blancy Pro will be assessed during the Human Repeat Insult Patch Test (HRIPT) challenge phase. After a two-week rest period, patches containing the investigational product and control materials will be applied to previously unexposed skin sites. Skin reactions will be evaluated 15 to 30 minutes after patch removal and graded according to the International Contact Dermatitis Research Group (ICDRG) criteria. Skin reactions will be graded according to the International Contact Dermatitis Research Group (ICDRG) criteria, ranging from 0 (negative reaction) to 4 (strong positive reaction). Higher grades indicate greater skin reactivity.

  4. Dermal Photoirritation Assessed by Phototest Using ICDRG Criteria

    Time frame: Day 2 and Day 4

    Dermal photoirritation following application of Blancy Pro will be assessed using phototest procedures. Patches containing the investigational product and control materials (saline solution, mineral oil, patch without product, and adhesive tape control) will be applied to the medial back. After 24 hours, patches will be removed, skin reactions will be assessed, and the test sites will be exposed to ultraviolet A (UVA) radiation at a dose of 5 J/cm². Additional assessments will be performed 48 hours after irradiation according to the International Contact Dermatitis Research Group (ICDRG) grading criteria. Skin reactions will be graded according to the International Contact Dermatitis Research Group (ICDRG) criteria, ranging from 0 (negative reaction) to 4 (strong positive reaction). Higher grades indicate greater skin reactivity.

  5. Dermal Photosensitization Assessed by Phototest Induction Phase Using ICDRG Criteria

    Time frame: Day 2, Day 4, Day 5, Day 8, Day 10, and Day 12

    Dermal photosensitization following repeated application of Blancy Pro and controlled ultraviolet A (UVA) exposure will be assessed during the phototest induction phase. Patches containing the investigational product and control materials will be applied to the medial back and irradiated with UVA at a dose of 5 J/cm². Skin reactions will be evaluated 15 to 30 minutes after patch removal and graded according to the International Contact Dermatitis Research Group (ICDRG) criteria. Skin reactions will be graded according to the International Contact Dermatitis Research Group (ICDRG) criteria, ranging from 0 (negative reaction) to 4 (strong positive reaction). Higher grades indicate greater skin reactivity.

  6. Dermal Photosensitization Assessed by Phototest Challenge Phase Using ICDRG Criteria

    Time frame: Day 30 and Day 32

    Dermal photosensitization following repeated application of Blancy Pro will be assessed during the phototest challenge phase. After a two-week rest period, patches containing the investigational product and control materials will be applied to two previously unexposed skin sites. One test area will be irradiated with ultraviolet A (UVA) radiation at a dose of 5 J/cm². Skin reactions in both test areas will be evaluated 15 to 30 minutes after patch removal and graded according to the International Contact Dermatitis Research Group (ICDRG) criteria. Skin reactions will be graded according to the International Contact Dermatitis Research Group (ICDRG) criteria, ranging from 0 (negative reaction) to 4 (strong positive reaction). Higher grades indicate greater skin reactivity.

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

Clinical Evaluation of the Allergenic Potential of a Cosmetic Product Using the Human Repeat Insult Patch Test (HRIPT) and Phototest

Acronym: HRIPT + FOTO

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 1, 2026
Registry last updated
Sep 1, 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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