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Clinical Trials/CTRI/2019/12/022244
CTRI/2019/12/022244CompletedPhase 3

A multicentre, double-blind, randomized, single-period, placebo-controlled, parallel group study of Adapalene 0.1% and Benzoyl Peroxide 2.5% Topical Gel of BELUPO Inc., Croatia (Test) and Epiduo Gel (Adapalene 0.1% and Benzoyl Peroxide 2.5%) (Reference) of Galderma (EU) in subjects with mild to moderate facial acne vulgaris

BELUPO Pharmaceuticals and Cosmetics Incorporated0 sites650 target enrollmentStarted: TBDLast updated:
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Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Enrollment
650
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Ba/be

Eligibility Criteria

Inclusion Criteria

  • •1.Healthy male or non-pregnant female aged between >= 12 and <= 40 years with a clinical diagnosis of facial acne vulgaris
  • •2.Subject having >= 30 to <= 100 non-inflammatory lesions (i.e., open and closed comedones) and >= 20 to <= 50 inflammatory lesions (i.e. papules and pustules) and or <= 1 nodulocystic lesions (i.e., nodules and cysts) on the face which will be evaluated as per the Format of Appendix 4 by Principal investigator/Co-Investigator
  • •3.Subject having clinical diagnosis of facial acne vulgaris severity grade 2 or 3 as per IGA(Appendix7)
  • •4.Subject willing to refrain from use of all other topical acne medications or antibiotics during the 84 days treatment period
  • •5.Subject/ LAR/ parent/ guardian/ Impartial Witness willing to give their written informed consent and written informed assent (in case of subject < 18 years) to participate in the study
  • •6.Subject used the same brand of make-up for a minimum period of 2 weeks prior to randomization and willing to agree to not change the make-up brands or types during the study
  • •7.Females must use acceptable and effective methods of contraception such as the following:
  • •A)Sexual abstinence
  • •B)Double barrier method
  • •C)Intrauterine Device (IUD)
  • •D)Progestin Implant (i.e. Implanon or its equivalent)
  • •E)Oral contraceptives
  • •8.Medical history and physical examination without clinically relevant abnormalities
  • •9.All vital signs (i.e. blood pressure, body temperature, heart and respiration rate) within the normal range:
  • •systolic blood pressure: 100 - 140 mmHg
  • •diastolic blood pressure: 60 - 90 mmHg
  • •body temperature: for axillary readings [97°F (36.1°C) - 99°F (37.2°C)], or for oral readings [98°F (36.7°C) - 100°F (37.8°C)]
  • •heart rate (pulse): 60 - 100 bpm
  • •respiration rate: 12 - 20 breaths/min
  • •Blood pressure will be measured after the subject has rested for at least 5 minutes in supine position

Exclusion Criteria

  • •1.Subject having presence of any skin condition that would interfere with the diagnosis or assessment of facial acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acne form eruptions caused by medications, steroid acne, steroid folliculitis or bacterial folliculitis)
  • •2. Subject having excessive facial hair (e.g. beards, sideburns, moustaches etc.) that would interfere with diagnosis or assessment of acne vulgaris as per the discretion of Principal investigator (PI)
  • •3. Subject with history of hypersensitivity or allergy to any medication (regardless the method of administration) and/or cosmetic product.
  • •4. Subject used oral retinoids (e.g. Isotretinoin) or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed) within 6 months prior to baseline
  • •5. Subject used estrogens or oral contraceptives for less than 3 months prior to baseline; use of such therapy must remain constant throughout the study
  • •6. Subject used cryodestruction or chemodestruction, dermabrasion, photodynamic therapy, acne surgery, intralesional steroids, or x-ray therapy on face within 1 month prior to baseline or planning to use during the study
  • •7. Subject used systemic steroids, systemic antibiotics, systemic treatment for acne vulgaris (other than oral retinoids, which require a 6 month washout), systemic anti-inflammatory agents or immunosuppressive drugs within 1 month prior to baseline or planning to use during the study
  • •8. Subject used topical steroids, topical retinoids, topical acne treatments including over-the-counter preparations, topical anti-inflammatory agents, or topical antibiotics on the face within 2 weeks prior to baseline or planning to use during the study
  • •9. Subject used tanning booths, sunbathing or excessive exposure to the sun or planning to use during the study
  • •10. Subject with damaged skin on his/her face, either broken (cuts or abrasions), eczematous or sunburned.
  • •11. Subject who is planning to use spironolactone during the study
  • •12. Subject who had participated in another investigational drug or device research study within 30 days of enrolment
  • •13. Subject who used any medication or has any disease which in the judgment of the Investigator will interfere with the conduct or interpretation of the study
  • •14. Female subject who is pregnant, nursing or planning a pregnancy during the study
  • •15. Any reason for which, in the opinion of the Investigator, the subject should not participate in the study.

Investigators

Sponsor
BELUPO Pharmaceuticals and Cosmetics Incorporated

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