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

NCT03853512 | Completed Phase 4

• 1 other identifier: 20507
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Recovery

Keywords

Dermal spray; Peeling; Skin hydration; Consumer satisfaction; Sensorial perception

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Skin properties of the participants

  Up to 23 days

• Treatment satisfaction

  Up to 23 days

• Product evaluation

  Up to 23 days

• Number of adverse events by dermatological evaluation

  Up to 23 days

• Number of adverse events by gynecological evaluation

  Up to 23 days

Study Arms (2)

Women_Inguinal side BAY207543

EXPERIMENTAL

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.

Drug: BAY207543 (Bepanthol, Bepantol® Derma Spray); Other: Semisolid vaseline

Women_Inguinal side Vaseline

ACTIVE COMPARATOR

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.

Drug: BAY207543 (Bepanthol, Bepantol® Derma Spray); Other: Semisolid vaseline

Interventions

BAY207543 (Bepanthol, Bepantol® Derma Spray) DRUG

Product is applied to one side of the inguinal region.

Women_Inguinal side BAY207543; Women_Inguinal side Vaseline

Semisolid vaseline OTHER

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

Women_Inguinal side BAY207543; Women_Inguinal side Vaseline

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Medcin Instituto da Pele

São Paulo, 06023-070, Brazil

Location

Related Links

• Click here to find results for studies related to Bayer products

MeSH Terms

Conditions

Consumer Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2019
• First Posted: February 25, 2019
• Study Start: February 12, 2019
• Primary Completion: March 13, 2019
• Study Completion: March 13, 2019
• Last Updated: March 11, 2020

Record last verified: 2020-03

Locations

BR (1)