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

Bayer33 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Skin Recovery

Interventions

BAY207543 (Bepanthol, Bepantol® Derma Spray)DRUG

Product is applied to one side of the inguinal region.

Semisolid vaselineOTHER

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Medcin Instituto da Pele

São Paulo, Brazil

Outcomes

Primary Outcomes

Transepidermal water loss by TEWL probe

The transepidermal water loss (TEWL) is measured in g m2 h-1 with a Tewameter TM300.

Time frame: Up to 23 days

Secondary Outcomes

Skin properties of the participants

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).

Time frame: Up to 23 days

Treatment satisfaction

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).

Time frame: Up to 23 days

Product evaluation

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).

Time frame: Up to 23 days

Number of adverse events by dermatological evaluation

Time frame: Up to 23 days

Number of adverse events by gynecological evaluation

Time frame: Up to 23 days

Severity of adverse events by dermatological evaluation

Time frame: Up to 23 days

Severity of adverse events by gynecological evaluation

Data from ClinicalTrials.gov

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