A Study to Gain Information How Well Dexpanthenol Dermal Spray Helps the Skin to Recover After a Peeling in the External Genital Area of Women

NCT ID: NCT03853512

Last Updated: 2020-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-12

Study Completion Date

2019-03-13

Brief Summary

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In this study, researchers want to learn more about the effect of dexpanthenol dermal spray on skin recovery after a dermatological procedure (peeling) in the intimate area of women.

After the peeling, participants will return within 3 weeks for 4 visits to the study center to investigate the skin conditions such redness, irritation, softness and possible side effects. In addition, study participants will be asked about their general acceptance of dexpanthenol dermal spray.

Detailed Description

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The primary objective is to evaluate the efficacy of the test product to aid skin recovery after peeling in the female intima and inguinal region.

Secondary objectives comprise clinical efficacy with respect to skin hydration, softness, vitality, appearance etc. and skin recovery, consumer judgement of product performance and acceptability, and safety.

Conditions

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Skin Recovery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Women_Inguinal side BAY207543

Adult women apply BAY207543 to one side of the inguinal region, and semisolid vaseline to the the opposite side after skin peeling. The area with BAY207543 will be investigated.

Group Type EXPERIMENTAL

BAY207543 (Bepanthol, Bepantol® Derma Spray)

Intervention Type DRUG

Product is applied to one side of the inguinal region.

Semisolid vaseline

Intervention Type OTHER

Product is applied to the other side of the inguinal region.

Women_Inguinal side Vaseline

Adult women apply BAY207543 to one side of the inguinal region, and semisolid vaseline to the the opposite side after skin peeling. The area with the vaseline will be investigated.

Group Type ACTIVE_COMPARATOR

BAY207543 (Bepanthol, Bepantol® Derma Spray)

Intervention Type DRUG

Product is applied to one side of the inguinal region.

Semisolid vaseline

Intervention Type OTHER

Product is applied to the other side of the inguinal region.

Interventions

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BAY207543 (Bepanthol, Bepantol® Derma Spray)

Product is applied to one side of the inguinal region.

Intervention Type DRUG

Semisolid vaseline

Product is applied to the other side of the inguinal region.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Phototypes I and II according to the Fitzpatrick scale;
* Participants willing to have peeling in the genital area to improve the general appearance of the skin and bleaching of spots.

Exclusion Criteria

* Pathologies and/or skin injuries, such as psoriasis, sensitive skin, skin cancer, atopic dermatitis or other medical criteria to be considered at the time of evaluation
* Hyperpigmentation in the test area that interfere with the evaluation of possible reactions (vascular malformations, scars, increase of pilosity and large amount of nevi)
* Pathologies and/or active skin injuries (local and/or disseminated) in the evaluation area
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Medcin Instituto da Pele

São Paulo, , Brazil

Site Status

Countries

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Brazil

Related Links

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https://clinicaltrials.bayer.com/

Click here to find results for studies related to Bayer products

Other Identifiers

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20507

Identifier Type: -

Identifier Source: org_study_id

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