A Study to Gain Information How Well Dexpanthenol Dermal Spray Helps the Skin to Recover After Laser Hair Removal in the Groin and Intimate Area

Bayer

Status and phase: Completed; Phase 4

Conditions: Skin Recovery

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT03853525

20506

Details and patient eligibility

About

In this study, researchers want to learn more about the effect of dexpanthenol dermal spray on skin recovery after a dermatological procedure for hair removal (laser depilation) in the groin and intimate area in adult women.

After the hair removal procedure, participants will return within 3 weeks for 3 visits to the study center to investigate the skin condition such as redness, irritation, softness of skin and possible side effects. Study participants will also be asked about their general acceptance of dexpanthenol dermal spray.

Full description

The primary objective is to evaluate the efficacy of the test product to aid skin recovery after lasering depilation in the 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.

Enrollment: 35 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Phototypes I and II according to the Fitzpatrick scale
• Participants willing to have a dermatological procedure (laser depilation) in the inguinal region to remove hairs in the region

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
• Hyperpigmentations 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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35 participants in 2 patient groups

Women_Inguinal side BAY207543

Experimental group

Description:

Adult women apply BAY207543 randomized to one side of the inguinal region and semisolid vaseline to the other side of the inguinal region after laser depilation. The side with BAY207543 is investigated.

Treatment:

Drug: BAY207543 (Bepanthol, Bepantol® Derma Spray)

Other: Semisolid vaseline

Women_Inguinal side Vaseline

Active Comparator group

Description:

Adult women apply BAY207543 randomized to one side of the inguinal region and semisolid vaseline to the other side of the inguinal region after laser depilation. The side with vaseline is investigated.

Treatment:

Drug: BAY207543 (Bepanthol, Bepantol® Derma Spray)

Other: Semisolid vaseline