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

Phase 4

Completed

• Conditions: Skin Recovery
• Interventions: Drug: BAY207543 (Bepanthol, Bepantol® Derma Spray); Other: Semisolid vaseline

• Registration Number: NCT03853512
• Lead Sponsor: Bayer

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-02-12
• Study First Submitted: 2019-02-15
• Study First Submitted QC: 2019-02-22
• Study First Posted: 2019-02-25
• Primary Completion: 2019-03-13
• Study Completion: 2019-03-13
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-10
• Last Update Posted: 2020-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 33

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Women_Inguinal side BAY207543	BAY207543 (Bepanthol, Bepantol® Derma Spray)	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.
Women_Inguinal side BAY207543	Semisolid 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 BAY207543 will be investigated.
Women_Inguinal side Vaseline	BAY207543 (Bepanthol, Bepantol® Derma Spray)	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.
Women_Inguinal side Vaseline	Semisolid 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.

Primary Outcome Measures

Name	Time	Method
Transepidermal water loss by TEWL probe	Up to 23 days	The transepidermal water loss (TEWL) is measured in g m2 h-1 with a Tewameter TM300.

Secondary Outcome Measures

Name	Time	Method
Skin properties of the participants	Up to 23 days	Investigators assess various skin properties of the participants with a questionnaire (each scored from 1 to 5), resulting in an overall efficacy score from 12 to 60 (a higher score represents higher efficacy).
Treatment satisfaction	Up to 23 days	Participants assess their treatment satisfaction with a questionnaire consisting of 19 items (each item is scored from 1-5) resulting in a score range of 19 to 95 (a higher score represents better treatment satisfaction).
Product evaluation	Up to 23 days	Participants assess their sensorial perception of different product attributes (e.g. smell, absorption) with a questionnaire consisting of 6 items (each item is scored from 1-5) resulting in a score range from 6 to 30 (a higher score represents higher product satisfaction).
Number of adverse events by gynecological evaluation	Up to 23 days
Severity of adverse events by dermatological evaluation	Up to 23 days
Number of adverse events by dermatological evaluation	Up to 23 days
Severity of adverse events by gynecological evaluation	Up to 23 days

Trial Locations

Locations (1)

Medcin Instituto da Pele; 🇧🇷 Sao Paulo, Brazil