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

Skin Recovery Clinical Trial

Official title:

Safety Assessment, Instrumental and Perceived Efficacy 21 Days of Use at Home - Bepantol Derma Spray® Dermal and Gynecological Acceptability Assessment.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03853512
• Other study ID #: 20507
• Status: Completed
• Phase: Phase 4
• Start date: February 12, 2019
• Est. completion date: March 13, 2019

Study information

• Verified date: March 2020
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: March 13, 2019
• Est. primary completion date: March 13, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Skin Recovery

Intervention

Drug:
• BAY207543 (Bepanthol, Bepantol® Derma Spray)
Product is applied to one side of the inguinal region.

Other:
• Semisolid vaseline
Product is applied to the other side of the inguinal region.

Locations

Country	Name	City	State
Brazil	Medcin Instituto da Pele	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transepidermal water loss by TEWL probe	The transepidermal water loss (TEWL) is measured in g m2 h-1 with a Tewameter TM300.	Up to 23 days
Secondary	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).	Up to 23 days
Secondary	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).	Up to 23 days
Secondary	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).	Up to 23 days
Secondary	Number of adverse events by dermatological evaluation		Up to 23 days
Secondary	Number of adverse events by gynecological evaluation		Up to 23 days
Secondary	Severity of adverse events by dermatological evaluation		Up to 23 days
Secondary	Severity of adverse events by gynecological evaluation		Up to 23 days

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