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Dermatological Assessment of Photoallergy and Phototoxicity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04250623
Recruitment Status : Not yet recruiting
First Posted : January 31, 2020
Last Update Posted : January 31, 2020
Information provided by (Responsible Party):
Herbarium Laboratorio Botanico Ltda

Brief Summary:

This is a clinical study for health care product safety assessment. The research will be conducted with 40 subjects, aged 18 to 70 years. The product will be applied on the right and/or left participant back for 3 consecutive weeks. After 10 days, will have another application of the same product, which will be removed in 24 hours. Medical evaluation will be available throughout the study to assess possible adverse events.

The objective of the study is to observe the effects of the application of the product on the skin and prove the absence of photoallergy and phototoxicity.

Condition or disease Intervention/treatment Phase
Sensitivity, Contact Other: Health care product (gel) Not Applicable

Detailed Description:
40 subjects, aged 18 to 70 years, phototypes II to III (according to Fitzpatrick classification). The patch test will be used to verify the absence of photoallergy and phototoxicity by the investigational products. The products will be applied twice a week for 3 consecutive weeks, as they are over semi-occlusive dressings. The product will remain in contact with the skin for 24 hours, after product removal the area will be irradiated with ultraviolet lamp A and B (UVA/UVB). Then, the procedure will be repeated after 10 days of wash out.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Clinical trial, single-arm
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Dermatological Assessment of Photoallergy and Phototoxicity Under Controlled and Maximised Conditions.
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Arm Intervention/treatment
Experimental: subjects, 18-70 y, healthy
subjects, 18-70 y, healthy
Other: Health care product (gel)
hyaluronic acid intimate moisturizing gel (to be applied on the subject's skin)

Primary Outcome Measures :
  1. Absence [ Time Frame: 6 weeks ]
    Absence occurence of phototoxicity and photoallergy

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy participants;
  • Non-injured skin in the test region;
  • Agreement to adhere to the test procedures and requirements and to attend the institute on the day(s) and at the time(s) determined for the evaluations;
  • Ability to consent to participation in the study;
  • Age from 18 to 70 years;
  • Phototype (Fitzpatrick): II and III;
  • Any gender

Exclusion Criteria:

  • Skin marks in the experimental area;
  • Active dermatoses (local or widespread);
  • Pregnant or breastfeeding women;
  • History of allergic reactions, irritation or intense feelings of discomfort to topical products;
  • History of phototoxic or photoallergic reactions;
  • History of allergy to materials used in the study;
  • History of atopy;
  • Personal or family pathological history of skin cancer;
  • History of pathologies aggravated or triggered by ultraviolet radiation;
  • Carriers of immunodeficiencies;
  • Intense sun exposure or tanning session up to 15 days before the initial evaluation;
  • Predicted intense sun exposure or tanning session during the course of the study;
  • Predicted bathing in the sea, pool or bathtub during the study;
  • Participants who practice water sports;
  • Dermography;
  • Use of the following topical or systemic drugs: immunosuppressants, antihistamines, non-hormonal anti-inflammatory drugs and corticoids up to 2 weeks prior to selection or, considering deposit corticoids, the interval shall be 1 month prior to selection;
  • Use of topical or systemic photosensitizing drugs;
  • Treatment with acid vitamin A and/or its derivatives via oral or topical until 1 month before the beginning of the study;
  • Aesthetic and/or body dermatological treatment until 3 weeks before selection;
  • Vaccination during the study or until 3 weeks before the study;
  • Being or having participated in another clinical trial terminated less than 7 days before selection, in case the previous trial is acceptable in use;
  • Being or having participated in another clinical trial terminated less than 21 days ago, in case the previous trial is compatible or Adverse Reaction investigative;
  • History of absence of adherence or unwillingness to adhere to the study protocol;
  • Professionals directly involved in the execution of this protocol and their relatives.
  • Any condition not mentioned above that, in the opinion of the investigator, may compromise the evaluation of the study.
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Responsible Party: Herbarium Laboratorio Botanico Ltda Identifier: NCT04250623    
Other Study ID Numbers: All-S-FA-FT-SO-PAD-074832
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: January 31, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermatitis, Phototoxic
Dermatitis, Photoallergic
Dermatitis, Contact
Immune System Diseases
Dermatitis, Irritant
Skin Diseases
Photosensitivity Disorders
Skin Diseases, Eczematous
Dermatitis, Allergic Contact
Hypersensitivity, Delayed